Parastomal hernia: investigation and treatment

Pia Näsvall

Department of Surgery and Perioperative Sciences

Umeå 2015

Responsible publisher under swedish law: the Dean of the Medical Faculty

This work is protected by the Swedish Copyright Legislation (Act 1960:729)

Umeå University Medical Dissertations

New Series No 1707

Copyright: Pia Näsvall

ISBN: 978-91-7601-241-3

ISSN: 0346-6612

Cover picture by Åsa Lundin

Electronic version available at://umu.diva-portal.org/

Printed by: Print & Media

Umeå University, SE-901 87 Umeå, Sweden

“Never measure the height of a mountain, until you have reached the top.

Then you will see how low it was.”

Dag Hammarskjöld

i

Table of Contents

Table of Contents i Abstract ii List of Abbreviations iv Sammanfattning på svenska vii Introduction and background 11

Investigation 3 Surgical treatment 5 Quality of life 8

List of Publications 10 Aims of this Thesis 11 Patients and methods 120

Studies I and II 1Fel! Bokmärket är inte definierat. Study I 1Fel! Bokmärket är inte definierat. Study II 14 Study III 14 Study IV 15

Results 17 Study I 17 Study II 18 Study III 19 Study IV 22

Discussion and Future aspects 23 Acknowledgements 28 References 29

ii

Abstract

Background

Parastomal hernia is a common stoma complication causing the patient

considerable inconvenience. The patient becomes aware of a bulge around

the stoma, but a bulge is not always a parastomal hernia and diagnostics

must be performed to enable differential treatment. It is difficult to

distinguish between a bulge and a hernia. Results based on clinical

examination and computerised tomography (CT) in the supine position, have

not been convincing. Three-dimensional intrastomal ultrasonography (3D

US) is a novel technique shown to be promising in the assessment of stoma

complaints. Two studies were performed to determine inter- and intra-

observer reliability as well as the validity of 3D US as an alternative to CT

when assessing stoma complaints.

There are numerous options for the treatment of parastomal hernia, but

none has been shown superior. In the recent decades the use of mesh in the

repair of incisional and inguinal hernia has become routine. New materials

must be evaluated as there are potential morbidity and even mortality risks

with mesh repair. As recurrence of a parastomal hernia is an even greater

challenge, the method of choice should have a low risk for recurrence. A

prospective multicenter study was performed to evaluate safety and

recurrence rate when using Parastomal Hernia Patch BARDTM (PHP), a

mesh specially designed for parastomal hernia repair,.

A stoma has a profound impact on the patient´s daily life, both physical and

psychological. A parastomal hernia with its associated risk for leakage and

incarceration worsens the situation. Patient driven assessment of healthcare

outcome is important if we are to improve medical care. A quality of life

(QoL) survey was performed to assess the impact of parastomal bulging and

hernia on the patient´s daily life.

Methods

Forty patients were investigated and the 3D US images were twice evaluated

by two or three physicians to assess inter- and intra-observer reliability.

Totally 20 patients with stoma complaints requiring surgery were examined

with CT and 3D US prior to surgery. The findings were compared with the

intraoperative findings – regarded as the true outcome.

iii

Fifty patients with parastomal hernia requiring surgery were enrolled from

three hospitals. Patients were followed up one month and one year after

repair using PHP.

Patients still alive in 2008 who had been operated between1996 and 2004

for rectal cancer in Uppsala/Örebro-, Stockholm/Gotland-, and Northern

Regions (986 patients) and registered in the Swedish Rectal Cancer Registry

(SRCR) were invited to fill in four QoL questionnaires.

Results

Inter-observer agreement using 3D US reached 80% for the last 10 patients

examined, with a kappa value of 0.70. Intra-observer agreement for two

examiners was 80% and 95%. The learning curve levelled out at 30 patients.

Both CT and 3D US showed high sensitivity and specificity when compared

with intraoperative findings.

After surgery for parastomal hernia with a PHP, the complication rate at one

month was 30% and recurrence rate at one year was 22%. Twelve patients

were reoperated within one year.

In the QoL study, 31.5% of the patients with a stoma reported a bulging or a

hernia. 11.7% had been operated for parastomal hernia. A hernia or a bulge

gave rise to significantly more pain and impaired stoma function. Overall

QoL was inferior in patients with a permanent stoma compared to a group

without a stoma.

iv

List of Abbreviations

3D US Three-dimensional intrastomal ultrasonography

AP Loss of appetite

ASA American Society of Anesthesiologists physical classification

system

BI Body image

BMI Body mass index

BP Bodily pain

CF Cognitive function

cIH Concomitant incisional hernia

CO Constipation

CT Chemotherapy side-effects

DF Defaecation problems

DI Diarrhoea

DY Dyspnoea

EHS European Hernia Society

EORTC European Organisation for Research and Treatment of Cancer

QLQ-C30 Quality-of-Life Questionnaire for Cancer

QLQ-C38 Quality-of-Life Questionnaire for Colorectal

cancer

ePTFE Polytetrafluoroethylene

ERF Emotional role function

v

FA Fatigue

FI Financial impact

FP Future perspective

FSX Female sexual problems

Gen General health

GI Gastrointestinal symptoms

HA Hartmann’s operation

HAL Health Assessment Lab

HRQoL Health-related quality-of-life

IPOM Intraperitoneal on-lay mesh

LR+ Positive likelihood ratio

mcs Mental component summary

MH Mental health

MHz Megahertz

MI Micturating problems

MOT Medical Outcome Trust

NPV Negative predictive value

MSX Male sexual problems

NV Nausea and vomiting¨

PA Pain

pcs Physical component summary

PF Physical function

vi

PHP Parastomal Hernia Patch BARDTM

PPV Positive predictive value

PRF Physical role function

QoL Quality-of-life

RF Role function

SE Sexual enjoyment

SF Social function

SF-36 Short Form 36 questionnaire

SL Insomnia

SQ Stoma Questionnaire

SRCR Swedish Rectal Cancer Register

STO Stoma-related problems

SX Sexual function

USB Universal serial bus

V Vitality

WL Weight loss

vii

Sammanfattning på svenska

En stomi innebär att en tarmände dragits fram genom bukväggen och fästs i

huden för att avföringen ska komma ut den vägen. I akuta situationer med

svår infektion i bukhålan kan en stomi vara livräddande och i många fall

tillfällig. Dock förblir en stor andel av dessa permanenta. Behandling av

ändtarmscancer innebär i ungefär 30 % av fallen att patienten får en

permanent stomi efter operation, andra orsaker till stomi-operation är

inflammatorisk tarmsjukdom (Crohns sjukdom och ulcerös kolit),

inkontinens m fl. I Norrbotten får ungefär 130 patienter årligen en stomi och

om man extrapolerar antalet för hela Sverige landar man på fler än 4500

varje år. Det finns en mängd olika stomipåsar för bandagering och de flesta

sjukhus har stomi-terapeuter som kan stötta patienten och hjälpa till med

utprovning av lämpliga hjälpmedel. Själva placeringen av stomin på

bukväggen är viktig för att påsen ska sitta bra och inte orsaka läckage som i

sig kan vara mycket besvärande och generande.

I många fall fungerar stomin mycket bra men det finns komplikationer

kopplade till stomier. Ett bråck vid stomin kallas parastomalt bråck. Bråck

förekommer på lokalisationer där det finns en försvagning av bukväggen till

exempel i ljumskar och vid naveln där ofta medfödda försvagningar finns.

Bråck kan också uppstå vid förvärvade försvagningar efter tidigare

operationer och stomiöppningar då ett hål skapas genom bukväggen för

stomitarmen. Detta kan ge besvär i form av att det putar ut, att det smärtar

och det finns risk för inklämning av tarm eller annan del av bukhålans

innehåll, oftast fett. Inklämning kan kräva akut operation då cirkulationen

till den vävnad som klämts in kan vara hotad.

Parastomala bråck är vanliga, men riktigt hur vanliga är inte med säkerhet

fastställt. I litteraturen förekommer uppgifter att mellan några få procent

upp till drygt 70 procent av patienter med stomi utvecklar parastomalt

bråck. Om den sanna siffran är 50 % skulle drygt 2000 patienter utveckla

parastomala bråck i Sverige varje år. Det patienten märker av är oftast en

buktning kring själva stomin men om det är ett bråck eller en buktning utan

samtidigt bråck kan är svårt att avgöra med endast klinisk undersökning. Då

behandlingen av ett parastomalt bråck och en buktning bör skiljas åt bör

också diagnostiken av parastomala bråck vara god. Skiktröntgen av buken

(CT) är idag en rutinundersökning och ingår som utredning inför behandling

av och uppföljning efter ändtarmscancer, liksom vid en mängd andra

tillstånd. De studier man gjort avseende CT i ryggläge för diagnostik av

parastomala bråck visar dock på svårighetermed diagnostiken. Man har

också studerat CT liggande på mage och då visat på en högre känslighet för

viii

att upptäcka bråck. Nackdelar med CT är det faktum att patienten utsätts för

strålning samt att rutinmässiga undersökningar utförs i ryggläge.

Ultraljudsundersökningar har fördelen att inte utsätta patienten för

strålning. Tre-dimensionellt ultraljud har under en längre tid använts för

endoanala och endorektala undersökningar. Tre-dimensionellt intrastomalt

ultraljud (3D US) är en ny utveckling av metoden för att undersöka stomala

besvär. Undersökningen kan utföras dynamiskt, dvs. om bråck/buktning

uppkommer vid t ex hostning kan själva bildupptagningen göras under

hoststöt, och i direkt anslutning till den kliniska undersökningen.

De två första arbetena i avhandlingen handlar om 3D US och parastomala

besvär.

Arbete ett är en undersökning av hur stor överensstämmelsen var vid

bedömning av bilder vid upprepade tolkningstillfällen hos samma bedömare,

den sk intrabedömar-reliabiliteten, och mellan två olika bedömare –

interbedömar-reliabilitet. Totalt 40 patienter med besvär kopplade till sin

stomi deltog i studien. Samtliga undersöktes med 3D US och bildmaterialet

bedömdes därefter av två bedömare vid två tillfällen med en månads

mellanrum. Slutsatsen var att efter ca trettio undersökningar nåddes

inlärningskurvans platå och man hade en god överensstämmelse mellan

bedömningar både för samma bedömare och mellan de två bedömarna.

I delarbete två fastställdes validiteten av 3D US dvs.: mäter 3D US det vi vill

eller önskar mäta. Tjugo patienter med besvär kopplade till stomin som

grund för beslut om operativ åtgärd inkluderades i undersökningen.

Samtliga patienter undersöktes innan operation kliniskt, med CT i ryggläge

och med 3D US. Fynden vid operationen betraktades som det sanna utfallet

och jämfördes sedan med fynden på CT och 3D US. Resultaten visade på hög

känslighet (sensitivitet) för parastomala bråck både för CT och 3D US. Även

specificiteten var god. Dock kan man inte säkert säga att ett normalt

undersökningsfynd också utesluter parastomalt bråck (specificitet) då det

endast var patienter med besvär som ingick i studien.

Behandlingsalternativen för parastomala bråck är många, men inget har

visat sig vara överlägset. Under de senaste decennierna har olika nät-

metoder blivit rutin för att behandla ärrbråck och ljumskbråck. Nya

varianter av nät och nätmaterial utvecklas ständigt och det är viktigt att

utvärdera nyttan och riskerna med dessa då det finns möjlig risk för både

komplikationer och död kopplat till användande av nät. Nät som behandling

av parastomala bråck finns beskrivet redan 1977 och även inom detta

område sker en ständig utveckling. Olika nät har testats i relativt små studier

ix

utan att något visat sig vara överlägset. Risken för komplikationer kopplat

till näten har visat sig vara betydande liksom även risken för att på nytt

utveckla ett parastomalt bråck, sk recidiv.

I det tredje arbetet i avhandlingen undersöks säkerhet och recidivrisk med

ett nät designat för behandling av parastomala bråck: Parastomal Hernia

Patch BARDTM (PHP). Femtio patienter med parastomala bråck opereras

med PHP under perioden 2008 till januari 2014. Patienterna följs sedan upp

efter en månad med klinisk undersökning och efter ett år med klinisk

undersökning och CT. Resultaten var nedslående med recidiv av parastomalt

bråck hos 30 % av patienterna redan efter ett år. 22 % av patienterna fick

någon form av komplikation och 12 % blev omopererade inom ett år.

Slutsaten blev att PHP inte tycks vara det optimala nätet för behandling av

parastomala bråck. Dock skiljer sig resultaten inte avsevärt från tidigare

studier.

Att leva med en stomi påverkar livskvaliten för många patienter. Livskvalité

är dock ett svårt mått och en högst personlig upplevelse och upplevd god

livskvalité måste inte innebära perfekt hälsa. Det finns ett talesätt: ”Det är

inte hur man har det, utan hur man tar det” som påverkar hur man upplever

sin situation. Trots detta är det av stor vikt att förstå hur olika sjukdomar och

behandlingar påverkar patienterna för att kunna förbättra vården ytterligare.

Ett antal olika frågeformulär har utvecklats för att mäta livskvalité (QoL).

Det fjärde arbetet är en QoL-studie av patienter vid liv 2008, som under

perioden 1996-2004 opererats för ändtarmscancer med eller utan

permanent stomi. Särskild tonvikt lades på de som hade bråck/buktning

kring sin stomi. 986 patienter (768 med stomi och 218 utan) fick 4 olika

QoL-formulär, totalt 453 patienter (336 med stomi och 117 utan) svarade på

enkäterna. Svarsfrekvensen, 46 %, gör att viss försiktighet bör iakttas om

resultaten generaliseras. En tredjedel hade ett bråck eller en buktning kring

sin stomi och 12 % hade opererats på grund av parastomalt bråck. Mental

hälsa, kroppsuppfattning liksom känslomässig funktion var sämre i gruppen

med stomi. Tidigare studier har visat på sexuella problem hos patienter med

stomi, den här studien visade dock sämre funktion hos individer utan stomi.

Däremot tycktes bråck/buktning ha negativ påverkan på den sexuella

funktionen. Bråck/buktning var förknippad med smärta och en oro för

läckage från stomin påverkade hur man upplevde stomifunktionen.

Övergripande QoL var sämre i gruppen med permanent stomi jämfört med

gruppen utan stomi och ett bråck eller buktning försämrade ytterligare QoL.

x

Parastomala bråck är svårbehandlade och det är viktigt att nya metoder

utvecklas och utvärderas. Lovande material är biologiska material och

patientegen vävnad. Diagnostiken bör också förfinas och ytterligare

utvärdering av 3D US är planerad. En studie planeras där patienter med

stomi, med och utan problem relaterade till stomin, undersöks med 3D US

innan planerad bukkirurgi. Att kunna förebygga uppkomst av parastomala

bråck vore bra. Studier har visat lovande resultat med ett nät för att skydda

mot bråck i samband med den primära stomioperationen. Dock har det

under senaste året kommit en rapport om oförändrad frekvens parastomala

bråck med eller utan nät. STOMAMESH är en stor svensk studie, utgående

från Sunderby sjukhus, där lottning sker mellan nät eller inte i samband med

den primära stomioperationen. Flera sjukhus deltar och målet för inklusion

bör nås under 2015 och den första rapporten kan sedan komma under 2016.

11

Introduction and Background

In a story that took place 1750 in Värmland Sweden, a farm-worker was impaled by accident on a broomstick

“in genom veka lifvet til tarmarna” (through the abdominal wall and into the intestines) resulting in a

spontaneous stoma. The man used a homemade leather bag as a stoma dressing. The story ends with “

Drängen är nu för öfrigt aldeles frisk, och kan göra hvarjehanda bondearbeten.” (the farm-worker is now

perfectly healthy and can perform all sorts of work on the farm). This description can be found in the

archives of the Royal Swedish Academy of Sciences1.

This story is one of several descriptions of spontaneous stoma-formation after an accident, or as a fistula

after incarcerated hernia2,3. Littré was probably the first to propose a stoma as part of treatment for

imperforate anus in infants in 1710, but the very first description of stoma-surgey was of an operation

performed in 1793 by Duret on a child with anal atresia2. The first stages in the history of surgery were

surrounded by risk. Mortality and morbidity rate were high, and just surviving was an enormous success. In

Copy with permission from the

Royal Swedish Academy of

Sciences. Author: Johan Hesselius

in the year 1750.

12

the beginning of the surgical era it was most important task to perform surgery quickly since anaesthesia was

not an option. Courageousness, and maybe madness, was probably necessary as well.

Over the last century, considerable progress has been made. Anaesthesiology has made it possible to perform

major surgery. Antibiotics and our knowledge of bacteria and antiseptics has significantly reduced

postoperative mortality and morbidity. Surgery has been refined with the development of minimally invasive

techniques and laparoscopy. Medical equipment is constantly being improved, and materials used for

different kinds of implants, such as hernia mesh, are continually being invented and improved.

The description from Värmland 1750 above describes a man who survived an accident with an expected

mortality close to 100%. He was lucky; the stoma-formation probably saved his life by preventing peritonitis.

Even today stoma-formation can save lives, especially in emergency situations with faecal peritonitis and/or

intestinal obstruction. There are many reasons for stoma-surgerys; cancer, Crohns disease, ulcerative colitis,

diverticulitis, urinary disorders and faecal incontinence to name but some. The total number of new stomas

each year in the county of Norrbotten in Sweden is approximately 130. Extrapolating from this figure the

number of new stomas in the whole of Sweden exceeds 4500 procedures each year.

Rectal cancer is common, and in Sweden approximately 2000 patients are diagnosed each year4. More than

one third of these patients will have a permanent stoma after their operation. Sweden seems to have a higher

proportion of permanent stomas after rectal cancer surgery compared to countries in southern Europa. The

use of very low anastomoses is probably more common in these countries, though the reason for this is not

fully understood, but social and emotional factors probably play an important role. Even within Sweden there

are differences, with a higher proportion of permanent stomas in the northern compared to the southern

part4.

A stoma requires appropriate stoma dressing and a proper placement on the abdominal wall if it is be

handled easily. Leakage and fear for leakage causes the patient considerable inconvenience and

embarrassment. Bad placement of the stoma will result in problems in changing dressings and trouble with

clothes5. The farm worker in 1750, with the stoma located at the site of the injury, arranged his stoma

dressing with a leather bag. The story does not tell whether or not its location on the abdominal wall was

optimal, but on the other hand, he had no choice.

The side-effects of a stoma include the risk of developing a parastomal hernia which might cause additional

problems with dressing and clothing as well as the risk for incarceration6,7. There is no standard definition of

a parastomal hernia. In some studies it is defined as a palpable bulge around the stoma during a Valsalva

maneuver8 whereas in other studies no definition is given9. Another definition of parastomal hernia is

protrusion of a peritoneal sack beside the stoma10. The sack may contain a part of the bowel other than the

stoma segment, or other intra-abdominal content. The incidence of parastomal hernia varies in studies from

a few percent up to 78%11,12. If one assumes the true figure to be 50%, more than 2000 patients in Sweden

will develop a parastomal hernia each year.

Quality-of-life (QoL) has become more important as an endpoint after surgery since survival after cancer has

improved as a result of chemotherapy and radiotherapy together with refined surgery and anaesthesia.

Patients expect a good QoL after surgery and we must develop ways of assessing the patient´s own

experience. The farm worker in 1750 was perfectly healthy and could perform all sorts of work on the farm

after his accident. It be that quality of life is judged differently nowadays, but to be able to perform MANY

activities after surgery is a high goal even today. Efforts aimed at giving patients the best possible QoL are

essential and should be given high priority.

This thesis focuses on patients with stoma and parastomal hernia. The incidence is still a matter of debate as

it is difficult to make the diagnosis. A bulge around the stoma is not always a hernia and should probably not

be treated as such. New diagnostic tools improve diagnostic accuracy. Several treatment options are

available, but at yet none has been shown to be superior. Is implantation of a mesh the solution? Finally, in

our efforts to attain a better outcome, the patient’s experience of HRQoL is important, and this aspect

requires more investigation.

13

Investigation

The human body may be examined in various ways. Our senses have been used throughout the history.

Manual examination, palpation, is still very important. A change in status can often be revealed by repeated

palpation over a short or long period of time. Auscultation can detect a pneumonia or heart disease. General

inspection often gives a good picture of the patient´s general condition. In former times doctors even used

their sense of taste to diagnose diabetes mellitus by the sweet taste of urine.

Radiology, laboratory tests and other techniques have evolved over the last century. It is now possible to

store, confirm and reproduce findings in large populations thanks to computers.

Investigation of stoma complaints can be done by inspection of the stoma. Location of the stoma is important

for easy dressing. A bulge around or above the stoma may cause considerable disability. Iirritation, or even

ulcerations, of the skin around the stoma may be a sign of inappropriate stoma appliances5,13.

Palpation is essential when examining a stoma. Difficulties in evacuation can be caused by a tight stoma

orifice or dislocation between the fascia and muscle layers causing a valve effect. Bulging and parastomal

herniation often leads to problems with leakage and stoma dressing14-16. It also affects body image and fitting

of clothes. Incarceration and the need for emergency surgical intervention can occur in the event of

herniation17,18.

To clinically distinguish between a bulge and a hernia is difficult19. A possible cause of bulge can be

denervation of parts of the abdominal wall when constructing the stoma, or after other abdominal

procedures. The bulge can also be caused by a part of the stoma segment protruding, or telescoping, through

the abdominal wall. A hernia can involve a part of the intestine other than the stoma segment - fatty tissue,

part of the omentum or other intra-abdominal content - herniating alongside the stoma. The European

Hernia Society´s (EHS) classification of parastomal hernias is a helpful when clinically assessing a

parastomal hernia20. This classification divide parastomal hernias into four groups; I and II up to 5 cm with

or without concomitant incisional hernia (cIH), respectively whereas III and IV more than 5 cm with or

without cIH. A radiological classification of parastomal hernia, based on CT-scan, divides the

bulging/hernias into five groups: 0 – no formation of a hernia sack, I a and b - the bowel forming the stoma

with a sack smaller or larger than 5 cm respectively, II – peritoneal sack containing omentum and finally III

– an intestinal loop, not the stoma segment in the sack, where class I b, II and III are regarded as parastomal

hernia10. Class I a describes a protruding/telescoping part of the bowel segment forming the stoma. Palpation

alone is not sufficient to differentiate between a bulge, a protrusion and a parastomal hernia19.

Computed tomography (CT) can be a helpful tool when examining patients. Studies have shown the

incidence of parastomal hernia to range between a few percent and 78% when combining CT and clinical

examination11,12. A Kappa index value of 0.4, when comparing diagnostics of parastomal hernia by CT scan

and clinical assessment, illustrate the diagnostic difficulties10. CT may underestimate clinical findings as

shown by Emanuelson et al21. A negative aspect of CT is exposure to radiation. CT in the prone position might

provide a more accurate information22 especially using the Valsalva manoeuver. However, in clinical practice

CT is performed in the supine position without a Valsalva manoeuver. The clinical significance of a

subclinical hernia, detected by CT, is not clear. On the other hand, the ability to distinguish a hernia from a

bulge or protrusion is very helpful when making decisions about treatment.

Ultrasonography does not expose the patient to radiation. Ordinary two-dimensional ultrasound is

dependent on the examiner. Second opinion of the images is often not possible. Three-dimensional

ultrasonography has been developed for endoanal and endorectal examinations. In the rectum, adenomas

can be examined and the depth of tumour growth can be measured, making it possible to stage the

14

tumour23,24. Endoanal ultrasonography is a good diagnostic tool for perianal fistulae and abscesses25,26. An

advantage is the possibility to get a second opinion of the images. Three-dimensional intrastomal

ultrasonography (3D US) is a novel development of this technique providing the possibility to examine

parastomal complaints including the possibility and to revise interpretation27,28.

3D examination in erect position.

Subcutaneous tissue

Fascia

Muscle layer

Normal 3D US image with the probe in

the stoma.

15

However, this novel technique has to be scientifically evaluated. CT, on the other is hand, is an established

imaging technique and today a routine investigation.

Two papers in this thesis evaluate the validity and reliability of 3D US as an alternative to CT for the

assessment of parastomal complaints including evaluation of inter- and intra-observer evaluation.

Surgical treatment

The word stoma means mouth or opening, and natural stomas are, for example, the mouth and the anus.

Artificial intestinal stomas include an opening through the fascia and muscles of the abdominal wall. This

causes a weakening and thus possible locus for herniation29.

Operations that include ileo-colic, colic-colic, colo-rectal or other anastomoses are at risk for healing

disturbances, resulting in anastomotic leakage. Reasons for this include infection or poor perfusion. In such

circumstances, stoma deviation may be necessary. In other cases a stoma is required after resection of a very

low rectal cancer where anastomosis is not possible, or as part of palliative treatment.

A stoma may be permanent or temporary. Hartmann´s procedure (HA) (resection of the sigmoid colon,

blind closure of the distal bowel and an end-colostomy of the proximal bowel segment) is often planned with

a temporary stoma, but up to 40-50% eventually become permanent30. When HA is performed for low rectal

cancer, the stoma is permanent. Loop-stomas are mostly planned as temporary, but occasionally they are not

reversed and end up as permanent stomas. Between 25 and 40% of transverse loop colostomies are not

reversed18.

Meticulous surgical technique and precision is important when creating a stoma17. Stoma formation is often

undertaken at the end of a long operation to quote Shellito “there is a tendency at that point to rush the

process or leave it to a junior member of the surgical team”18. After radically resecting cancer, the patient’s

life may be saved, but a poorly constructed stoma can make a major difference to the patient’s QoL.

Poor stoma positioning can result in difficulties with stoma dressing, in term of both fitting and function5,31.

Leakage of faeces with soiling of clothes is not only embarrassing but can also cause irritation and even

3D US image, modulated in render-

mode. A parastomal hernia can be

seen.

Parastomal hernia

16

ulceration of the skin surrounding32. Special stomal barriers and frequent visits to the stoma nurse may be

necessary. From an economical point of view, a stoma that requires special dressings and barriers is

expensive and the cost for the community can be three times that of a well-functioning stoma13. Patients may

need to take time off work to visit the stoma nurse, affecting the patient’s economic situation16.

Not paying attention to the perfusion of the bowel when forming the stoma may result in ischaemia and

necrosis requiring emergency intervention17. Ischaemia, not requiring acute surgery may result in subsequent

stoma stenosis18. Other complications of stoma formation are prolapse of the stoma and peristomal fistula.

Patients with underlying disease, such as Crohn´s, are more likely to develop both fistulae33 and stenosis.

Parastomal herniation is a common complication to stomas; by some authors even claimed as not

avoidable34. Incidence figures range from a few percent up to 78%, but due to the difficulties of diagnosing

these figures must be considered difficult to interpret11. Asymptomatic hernias are common. A not negligible

proportion of patients have discomfort and complaints from a bulging stoma6. Parastomal hernia can

develop up to 20 years after the index operation, although in most cases much earlier7,35.

Occurrence of parastomal hernia is probably influenced both by habitual and technical factors. Malnutrition,

obesity, elevated intra-abdominal pressure and immunosuppressive drugs such as corticosteroids are all

likely to increase the risk for developing both incisional and parastomal hernias, though there is no stronger

scientific evidence than the opinion of authors11. Surgically, technical factors proposed to influence on

parastomal herniation include; size of trephine hole in the abdominal wall; closure of the lateral space;

fixation to the fascia; location of the opening through the rectus muscle and the use of intraperitoneal or

extraperitoneal technique. Contact with a stoma therapist has also been proposed having influence.

There is no robust evidence in support of stoma passage through or lateral to the rectus muscle to reduce the

rate of parastomal herniation36. Size of the opening in the abdominal wall has been much debated, and a

trephine allowing one or two fingers to pass is usually suggested11, despite the fact that finger size varies.

Some recommendations of the size of the aperture in centimeters have been made37,38 and specially designed

devices to enable a reproducible aperture have been designed39,40. There are reports showing that larger

apertures are associated with a higher incidence of parastomal hernia41. However, the aperture need

probably not be wider than that necessary to allow the bowel to pass without causing perfusion

embarresment.

Extraperitoneal techniques have been suggested to reduce the risk for parastomal hernia formation. Studies

comparing transperitoneal and extraperitoneal end colostomy formation have reported a lower parastomal

hernia rate with the extraperitoneal route11,42. However, only one of five studies showed a statistically

significant difference7. None of these studies was randomised or controlled.

Stomal necrosis

17

Fixation of the bowel to the fascia or abdominal wall has not been shown to prevent hernia formation11. An

acute surgical intervention that includes a stoma has been proposed as a factor contributing to hernia

formation. A retrospective study, however, could not show any difference between the elective and

emergency setting43. The employment of a stoma therapist in choosing a suitable location for the stoma on

the abdominal wall may play an important role16, though this has not been confirmed44.

There have been a few small studies on the use of prophylactic mesh reinforcement at the primary stoma

operation to reduce the rate of parastomal hernia formation. Mesh material varied between the studies as

well as the placement of the mesh – onlay, sublay or intraperitoneal42. A meta-analysis including three,

though small, randomised controlled studies, including in all 128 patients, showed promising results with a

hernia rate of 12.5% in the mesh group compared to 53% in the control group45. In contrast a retrospective

study from Västerås, Sweden, showed no change in parastomal hernia rate (23%) before and after the

introduction of prophylactic mesh in routine practice46.

There are several ways of treating parastomal hernia, but the results are usually disappointing. Local tissue

repair represents s convenient way to reduce and treat a hernia. The stoma can be maintained in its position

and laparotomy can be avoided. The recurrence rate, however, is disheartening, ranging from 48.4 to 66.4%

according to data published in a meta-analysis47. Postoperative complications were reported in 14.1% of the

patients in the same meta-analysis. One study compared local tissue repair with stoma relocation, revealing

recurrence rates of 76% and 33% respectively48.

Stoma relocation is sometimes needed due to unsatisfactory placement at the index operation, resulting in

leakage and problems with stoma dressing. In eight small studies, including only 91 patients11, stoma

relocation to treat parastomal hernia, had a reported recurrence rate a ranging from 0 to 76.2%. It may be

that a new location on the contralateral side of the abdominal wall can give a lower recurrence rate49, but the

collagen characteristics are still the same.

Mesh is an established method to treat inguinal as well as incisional hernia. In 1977, an early report described

polypropylene mesh, applied as a fascial on-lay prosthesis, to be an option in parastomal hernia repair50.

Since then, several studies have described mesh in the sub-lay and intraperitonal on-lay (IPOM) positions in

parastomal hernia repair42. In a meta-analysis, on-lay mesh repair was shown to have a recurrence rate of

14.8% (median follow-up 40 months) and a complication rate of 11.1% 47. Mesh in the sublay position had a

recurrence rate of 7.9%, and a total complication rate of 14.5%, but the median follow-up time was short; 24

months with a range of 12-32 months47.

The IPOM technique is often used laparoscopically when repairing incisional hernia. Meshes designed for

parastomal hernias can be used both in open and laparoscopic surgery. The meshes are often of the

composite type consisting of one non-adhering material facing the bowel, and one adhering material towards

the abdominal wall. The stoma bowel is passed through an aperture in the mesh – “key-hole” – or lateral to

and between the mesh and the abdominal wall – the “Sugarbaker´s method”51. There are small studies

comparing the Sugarbaker and key-hole techniques performed laparoscopically, with a slightly lower

recurrence rates for Sugarbaker (Sugarbaker 11.6% and key-hole 20.8%), though the follow-up time was

relatively short; 24-36 months52. A combination of both Sugarbaker and key-hole – the sandwich technique –

has a reported hernia recurrence rate of 2.1% in one single-centre study, after a median follow-up of 20

months53.

Mesh material has varied between the studies and including: polytertrafluoroethylen (ePTFE),

polypropylene, biological implants and various composite meshes. The studies have been small and there is

no strong evidence supporting one technique in over another. New materials must be evaluated and the

safety profile is of paramount importance.

One paper in this thesis reports a prospective study evaluating safety and the recurrence rate using an IPOM

specially designed for the repair of parastomal hernia.

18

Quality of life

The farm-worker in Värmland could do all sorts of work and was in good health after his accident. His QoL is

described in a few words, but what he actually experienced cannot be interpreted from this story. QoL is a

personal experience, nevertheless it is important to assess how the patient experiences daily life and health.

Legislation on patient involvement in their own healthcare has also made health-related QoL (HRQoL) an

important ednpoint. Studies have shown that QoL assessment leads to more patient involvement in surgical

treatment decisions54. Good QoL is not always equivalent with a perfect health. There is a saying “it is not

how are, but how you feel” impying that even though a person has a serious or severe medical condition his

perceived QoL can be very good. In 1948 the World Health Organisation (WHO) stated health as being “the

state of complete physical, mental and social wellbeing and not merely the absence of disease or infirmity”55.

Many factors, social, emotional, physical, religious just to name a few, play an important role in a person’s

life. The WHO defines QoL as “individuals´ perception of their position in life in the context of the culture

and value system in which they live and in relation to their goals, expectations, standards and concerns”56.

Morbidity and mortality are important outcome measurements in medical care, but over recent decades

there has been a rise in interest in measuring and assessing health beyond these traditional indicators.

Several tools to measure the impact of disease and impairment on daily life have been developed and

validated. There is a lack of solid criteria on how to construct and validate health scales57. Validations of QoL

module tests among patients have been performed on several occasions. Test-retest reliability can be

obtained by a group of patients answering the test questionnaires two or three times58. Focus groups can be

used to obtain relevant questions59.

Patient interviews, often used in qualitative research, can add in-depth information of the perceived QoL and

provide additional information. This methodology focuses on smaller samples, often strategically chosen, in

contrast QoL questionnaires that are used for larger populations.

There are tools focusing on overall QoL and other more disease-specific tools. The overall QoL tools cover

topics of physical, psychological and social function, wellbeing and physical symptoms. Disease-specific tools

Ice-covered Luleå river 15th of March

2015.

19

focus on aspects of the disease and the treatment that may affect QoL. These tools often complement each

other, providing additional information about the patient’s situation and perceived QoL60.

Living with a stoma can evoke both anxiety and embarrassment, leading to changes in life quality61. Surgical

technique and placement of the stoma not too near the belt level or the waistband line were obviously

important, but patients successively adapt to the change in situation5,15,62. Leakage and difficulties in

applying and keeping stoma bags in place are reported to reduce QoL5 as do bulging and parastomal hernia6.

In the fourth paper in this thesis, patients operated for rectal-cancer answered four different HRQoL

questionnaires, providing information about their perception of living with or without a stoma. Special focus

was placed on the influence of a bulge or a parastomal hernia on QoL.

20

List of Publications

Strigård K, Gurmu A, Näsvall P, Påhlman L, Gunnarsson U.

Intrastomal 3D ultrasound; an inter- and intra-observer evaluation.

Int J Colorectal Dis 2013; 28: 43-47

Näsvall P, Wikner F, Gunnarsson U, Rutegård J, Strigård K.

A comparison between intrastomal 3D ultrasonography, CT scanning and findings at surgery in patients with

stomal complaints.

Int J Colorectal Dis 2014; 29: 1263-1266

Näsvall P, Rutegård J, Dahlberg M, Gunnarsson U, Strigård K.

Parastomal hernia repair with intraperitoneal mesh.

Submitted

Näsvall P, Rutegård J, Dahlstrand U, Löwenmark T, Gunnarsson U, Strigård K.

Quality of life with permanent stoma after rectal cancer surgery

Manuscript

21

Aims of this Thesis

Parastomal hernia is difficult to diagnose and the treatment options are numerous. No repair technique has

shown to be superior. Patient experience is of paramount importance if we are to be able to offer the best

possible treatment. This thesis focuses on three aspects of parastomal hernia;

the development of accurate diagnostic tools, enabling correct surgical decisions

the treatment of diagnosed parastomal hernia

the patient´s own experience of living with a stoma and its impact on daily life, with particular

emphasis on bulging and parastomal hernia

Paper I

To determine the inter- and intraobserver reliability of three-dimensional ultrasonography imaging in the

diagnosis parastomal hernia.

Paper II

To assess the validity of intrastomal three-dimensional ultrasonography as an alternative to computed

tomography for the assessment of stoma complaints

Paper III

To evaluate the safety and recurrence rate of parastomal hernia repair using a Parastomal Hernia Patch

BARDTM.

Paper IV

To evaluate the quality of life of patients living with a permanent stoma after rectal-cancer surgery, and the

prevalence and effect of parastomal hernia or bulging on QoL.

22

Patients and Methods

Studies I and II

3D US - three-dimensional intrastomal ultrasonography

3D US is a technique producing images which can be rotated and scrolled in different projections during

interpretation. The possibility of saving images and sending them to another investigator enables second

opinion. The images can be remodulated in render mode (computer-aided reconstruction of the images)

which provides better visualisation of structures by augmenting some and diminishing others63,64. The

investigation can be performed at the time of clinical examination, and the patient can be examined in both

the supine and erect position. The clinical investigation and imaging technique can thereby complement one

another. If the patient has stoma complaints in a specific position or during straining, the ultrasound-

examination can be performed in that specific situation. Study I focus on the reliability, and Study II on the

validity of 3D US.

Study I

Patients seeking healthcare due to stoma complaints i.e. bulging, suspected hernia, leakage, pain or other

stoma-related problems, were invited and signed informed consent obtained. Patients were recruited from

three hospitals; Sunderby Hospital, Karolinska University Hospital and Norrlands University Hospital, and

all, but a few with an ileostomy, had a colostomy.

According to the study protocol, patients were divided into a baseline group of twenty patients, and groups of

ten thereafter. Two or three physicians examined all patients clinically. 3D US performed by one of the

clinicians with the patient in both supine and erect positions, with and without a Valsalva manoeuver. The

images were transferred to USB memory sticks and interpreted by each physician separately. A protocol was

followed and each one of the examiners personally completed separate protocol-forms, both for the clinical

examination and 3D US investigation (Figure 1). Assessments according to the protocol were made after each

examination sequence, and a second assessment of the 3D US protocol was made one month later. Before the

second assessment, the first protocol was sent to a study nurse as to avoid bias at the second 3D US

assessment.

In the protocol differentiation between a bulge, a protrusion and a hernia was made. Hernia was defined as a

peritoneal sack protruding through a fascial defect beside the stoma-bowel. Any content in the hernia sack

was described as bowel, omentum or other. Protrusion was defined as subcutaneous excess of bowel forming

the stoma with no fascial defect. A bulge was what that seen clinically with the patient usually in erect

position. The reason for a bulge could be a hernia, protrusion or a bulging of the abdominal wall without

hernia or protrusion.

The physicians in this study had different degrees of experience in endoanal and endorectal 3D ÙS

examination, one with extensive experience and the other two with short period of previous training. The

ultrasound machine used was Profocus 2202 (BK Medical, Herlev, Denmark) with a 2050 transducer. The

transducer, fitted for enodanal and endorectal 3D US examinations, was covered with a water-filled balloon

and taped individually to fit the subcutaneous fatty tissue of each patient27. Normally 30-40 ml of water was

needed to fill the balloon, and the rectal setting with 9 MHz was used for the probe.

23

Statistical analyses were performed using Fleiss´ kappa, calculating inter-rater reliability with more than two

observers. Table 1 shows interpretation of the Fleiss´ kappa values. Congruence between investigators was

calculated as the proportion of unanimous assessments.

Figure 1 Protocol used for clinical and 3D US evaluation.

Table 1 Fleiss´kappa value and the interpretation of level of

agreement

< 0 Poor agreement

0.01 – 0.20 Slight agreement

0.21 – 0.40 Fair agreement

0.41 – 0.60 Moderate agreement

0.61 – 0.80 Substantial agreement

0.81 – 1.00 Almost perfect agreement

Investigator Patient name

Clinical investigation

Inspection; Erect bulge □ no bulge □

Position 9-12 □ 12-3 □ 3-6 □ 6-9 □

Supine bulge □ no bulge □

Position 9-12 □ 12-3 □ 3-6 □ 6-9 □

Palpation Normal □

Weakness □

Position 9-12 □ 12-3 □ 3-6 □ 6-9 □

Protrusion □

Hernia □

Position 9-12 □ 12-3 □ 3-6 □ 6-9 □

Ultrasound Normal □

Protrusion □

Hernia □

Position 9-12 □ 12-3 □ 3-6 □ 6-9 □

Intestine yes □ no □

Fascia circ. □ partial □ no ass. □

Rectus circ. □ partial □ no ass. □

Mesh no □ onlay □ sublay □

Comments □…………………......................

24

Study II

Twenty patients with stoma-related symptoms - hernia, protrusion, fistula related to implanted mesh - to

such a degree that surgery was judged necessary were enrolled into the study. Three hospitals recruited

patients; Sunderby hospital, Umeå University hospital and Karolinska University hospital Huddinge.

Preoperative assessment including CT of the abdomen, 3D US and clinical examination was performed.

Intraoperative findings, seen as the true outcome, were compared to findings at CT and 3D US. Three

investigators experienced in endoanal and endorectal ultrasonography performed the 3D US examination,

and two investigators blinded to the other interpretation evaluated all 3D US images. The ultrasound

machine was the same brand as in Study I and the technique described in a study by Gurmu et al27.

CT examinations were performed at the radiology department of each hospital participating, with the patient

in the supine position. Twice two radiologists blinded to each other’s evaluation interpreted the images, first

as a routine evaluation by an experienced radiologist and then a second time by a dedicated radiologist.

Surgery was performed at each hospital by experienced colorectal surgeons. All had a special interest in

stoma complaints and hernia. Findings at surgery were registered for later comparison with findings at the

preoperative assessment.

Statistical analyses for sensitivity, specificity, positive likelihood ratio (LR+), negative (NPV) and positive

predictive value (PPV) were planned using cross-tables in IBM SPSS Statistics 22 software packages.

Study III

Fifty consecutive patients seeking medical care due to parastomal hernia and symptoms related to the hernia

requiring surgery were invited to take part in the study. Symptoms included leakage, problems with stoma

dressings, bulging and signs of incarceration. Patients who did not agree to participation in the study was

offered surgery according to each department´s routine; stoma-relocation, narrowing of the stoma aperture,

or implant of a mesh in a sub-lay position. Demographic patient-related data including gender, body mass

index (BMI), ASA, presence of incisional hernia, peroperative blood loss, and type of stoma were recorded.

Preoperative assessment included CT of the abdomen in the supine position at each hospital´s radiology

department. The images were interpreted as a routine investigation by experienced radiologists. Repair was

performed using an intraperitoneal on-lay mesh (IPOM) technique with Parastomal Hernia Patch BRADTM

(PHP), specially designed mesh for parastomal hernia. This mesh consists of two layers; one of

polypropylene which is placed facing the abdominal wall to allow ingrowth and adherence to the peritoneum,

the other of polytetrafluoroethylene (ePTFE) with the property not adhere to the bowel or other intra-

abdominal content, and thus placed facing the bowel. The mesh is oval shaped with a key-hole aperture

allowing the intestine forming the stoma to pass through, and there are four ePTFE flaps around the hole by

which the intestine may be anchored, each with one suture (Figure 2). It is manufactured in two sizes; 12.5 x

15.5 cm and 15.5 x 20.5 cm.

25

After repositioning the content in the hernia and measuring the size of the hernia opening, the PHP was

placed with overlapping of the key-hole opening lateral to the stoma bowel. The mesh was tacked in place

through slits in the ePTFE-layer.

The operations were performed at the four participating hospitals by surgeons with good experience of using

the PHP. After postoperative mobilisation according to each hospital´s routine, patients were followed up at

one month and one year postoperatively. Clinical assessment for early complication at one month and

possible recurrence of parastomal hernia and late complications at one year was performed. CT was also

performed at one year.

Statistical analyses regarding hernia recurrence rate, early and late complications were performed using IBM

SPSS Statistics 22 software packages.

Study IV

There are several HRQoL forms available and in this study four different ones were used: the EORTC QLQ-

C30, the EORTC QLQ-C38, the SF-36 and the Stoma Questionnaire (SQ). Both the EORTC QLQ and SF-36

forms require a license for use, and these were obtained.

The European Organisation for Research and Treatment of Cancer (EORTC) is a non-profit organisation that

was started over 30 years ago by a group of experts interested in the field of QoL. Their aim was to develop

tools for measuring QoL in cancer trials. So far the EORTC has validated numerous HRQoL modules specific

for different cancer diagnoses, colorectal cancer being one of these58,65. The EORTC QLQ-C38 is a specific

module for used in colorectal cancer surveys66. The modules are translated into several languages, including

Swedish. It comprises 38 items grouped according to: a. function - body image (BI), future perspectives (FP),

sexual functioning (SX) and sexual enjoyment (SE): – and b. symptom – micturing problems (MI),

gastrointestinal symptoms (GI), chemotherapy side-effects (CT), defaecation problems (DF), stoma-related

problems (STO),weight loss (WL), male (MSX) and female (FSX) sexual problems. Each item is rated on a

scale by the patient.

PTFE flaps

Key-hole opening

ePTFE-layer to face the

bowel

Figure 2. Picture of the Parastomal

Hernia Patch BARDTM

26

The EORTC QLQ-C30 module must be used in conjunction with the EORTC QLQ-C38. The QLQ-C30

module is a general QoL questionnaire designed for cancer patients65,67. It comprises 30 questions covering

general well-being and is divided into: a. function groups (physical function (PF), role function (RF),

cognitive function (CF), emotional function (EF) and social function (SF)) b. symptom groups (fatigue (FA),

pain (PA), nausea and vomiting (NV)) and six single-item questions concerning dyspnoea (DY), insomnia

(SL), loss of appetite (AP), constipation (CO), diarrhoea (DI) and financial impact (FI). Global health status

is measured by combining the last two questions in the questionnaire.

The EORTC questionnaires were analysed according to the manual68 and the answers to the questions were

rescaled from 1 to 100. High scores in function and global QoL indicate healthy or high function level and

high QoL. In the symptom and the single item questions a high score indicates many symptoms.

The Medical Outcome Trust (MOT) started in 1992, and has been affiliate of the Health Assessment Lab

(HAL) since 2008 and is based in Boston, USA. It is a non-profit organisation aimed at improving healthcare

through promoting research on outcome measures. The Short Form 36 (SF-36) is a validated QoL

instrument translated into Swedish and produced by the MOT57,69. It comprises of 36 questions concerning:

physical functioning (PF), physical role functioning (PRF), bodily pain (BP), vitality (V), general health

(Gen), social functioning (SF), emotional role functioning (ERF), mental health (MH), physical component

summary (pcs) and mental component summary (mcs).

Software for the rescaling and scoring of data from the SF-36 comes together with the license agreement.

Rescaling converts the scores to a scale 1-100, were 100 indicates best possible health or no disability.

The SQ is a validated 15-item questionnaire designed for stoma-patients19. It focuses on how the stoma

affects the patients’ daily activities, sexuality, body appearance and any limitations to daily life.

Available data from Swedish “normal population” were used for comparison with both the SF-36 and EORTC

QLQ-C30 67,70,71. Comparisons of the data were performed by comparing mean values between groups using

Student´s independent t-test, p-values < 0.05 were considered significant. All analyses were performed with

IBM SPSS Statistics 22 software package.

Patients included in the study were identified in the SRCR. They were operated with resection surgery and

permanent colostomy (APR and HA) for rectal cancer between 1996 and 2004 in the Uppsala/Örebro,

Stockholm/Gotland and Northern Regions in Sweden. Patients operated in the Karolinska University Solna

and Sundsvall hospitals were excluded, since they had already adopted the use of prophylactic mesh around

the stoma. A control cohort of 275 patients operated with AR without permanent stoma in the Northern

Region was used as a control. In this group 57 (21%) still had a diverting loop-ileostomy in 2008 and were

thus regarded as having permanent stomas.

The HRQoL forms, with a stamped addressed envelope, were sent by mail to 986 patients (768 with and 218

without a permanent stoma) via the Mailit company. One reminder was sent to those not responding.

27

Results

Study I

Forty patients were included in the study, twenty in the base-line group and ten in each of two subsequent

groups. 3D US-images from the baseline group were assessed by all three investigators, and from the

following two groups by two investigators. A stepwise improvement in inter-observer agreement was

observed; from 70% in the baseline group, to 80% in the second group of ten patients. The Fleiss´kappa

value was 0.41 for the first twenty patients reaching 0.7 in the last ten, with a mean of 0.59 for the entire

cohort.

Intra-observer agreement was calculated for the most experienced and one for the other two investigators.

Despite the shorter training period for one investigator, the intra-observer agreement increased from

moderate to substantial. Intra-observer agreement also increased between each additional group. After 30

patients, reliability had reached “good” and “excellent” respectively. Results from the last ten patients

revealed that the learning curve levelled out at 30 patients (Table 2).

Table 2

Patient number

1-20 21-30 31-40 Total

Inter-observerreliability

Fless`kappa 0.41 0.55 0.70 0.59

Agreement 70% 70% 80% 72.5%

Intra-observer

reliability

Observer 1 Fleiss`kappa 0.66 1.0 0.76 0.79

Agreement 80% 100% 90% 93%

Observer 2 Fleiss´kappa 0.19 0.53 1.0 0.39

Agreement 70% 70% 100% 80%

28

Study II

Eight men and 12 women were included in the study. Table 3 shows demographic data. Findings at surgery

revealed 18 cases with a parastomal hernia. The other two patients were shown to have fistulae related to a

mesh implanted around the stoma. The fistulae had been detected at the preoperative 3D US examination.

Two of the 18 patients with a parastomal hernia had previously had a mesh implanted around the stoma. All

four previously implanted meshes were removed at surgery.

Nineteen patients were operated with a mesh; 17 applied as IPOM, one stoma-relocation in combination with

IPOM, and one with a mesh in the sub-lay position. The twentieth patient had the stoma moved without a

mesh.

The results of comparison between findings at surgery and those at the preoperative assessments (CT and 3D

US) are shown in Table 4. The sensitivities when comparing CTs evaluated the second time by a dedicated

radiologist, and 3D US, with findings at surgery were both 15/18 (83%). CTs evaluated in the routine setting

showed a sensitivity of 17/18 (94%). Specificity for both routine and dedicated CT evaluations was 1/2 and for

3D US 2/2. Positive predictive value (PPV) was 15/15 for 3D US, 17/18 for routine CT and 16/17 in the

dedicated CT evaluation. Negative predictive value (NPV) was 2/5 for 3D US, 1/2 for routine CT and 1/4 for

the dedicated CT evaluation. The positive likelihood ratio (LR+) value was 1.88 for the routine and 1.66

second for the dedicated CT evaluation of CT. LR+ was infinite for 3D US.

Table 3 Demographic data

Gender

Female/male 12/8

Age (years)

Median (range) 67 (19-91)

BMI

Median (range) 26 (19-35)

Reason for

stoma

Cancer 12

Diverticulitis 1

IBD 4

Other 3

29

Table 4 Cross-table comparing findings at surgery with the preoperative assessments.

Findings at surgery

Findings at 3D US interpretation No hernia Hernia

No hernia 2 3 5

Hernia 0 15 15

2 18 20

Findings at routine interpretation of CT

No hernia 1 1 2

Hernia 1 17 18

2 18 20

Findings at dedicated interpretation of CT

No hernia 1 3 4

Hernia 1 15 16

2 18 20

Study III

Fifty patients were enrolled in this study and demographic data are shown in Table 5. All patients were

operated with PHP in an elective setting. Means for operating time, blood loss and length of postoperative

stay are shown in Table 5. The smaller mesh was used in 35 patients whereas the remaining 15 cases were

reconstructed using the larger mesh.

The complication rate at one-month follow up was 16/50 (32%), all but one (pneumonia in conjunction with

a urinary tract infection) were considered surgical complications; six wound infections, five deep infections,

one stoma prolapse and three with postoperative intestinal obstruction. One of the deep infections proved to

be caused by leakage from the small intestine. At the one-month follow-up, seven (14%) patients had been

reoperated; two cases due to incarcerated recurrent parastomal hernia, and one, as mentioned above, due to

leakage of the small intestine (Table 6).

The clinically identified parastomal hernia recurrence rate at one-year follow-up was 11/50 (22%), and 17/50

had parastomal bulging. Due to meshes having been removed at reoperation already within one month, three

patients were censored and not followed up with CT at one year. Of the 47 patients examined with CT, a

recurrent parastomal hernia was found in 7/47 (15%); parts of the bowel other than the stoma segment was

found in the hernia in six patients, and omentum in the seventh. In eight patients, a stoma segment

protruding subcutaneously in the abdominal wall was seen on CT. A further five patients had been

reoperated by the one-year follow-up due to recurrent parastomal hernia, obstruction of small intestine,

incarcerated parastomal hernia, and ventral hernia (not related to the stoma). A total of 12/50 (24%) were

reoperated within one year after surgery (Table 6).

30

Table 5 Demographic and perioperative data

Patient gender Male/Female 27/23

Age (year) Median (range) 72 (23-93)

BMI Median (range) 27 (15-38)

ASA ASA 1 2

ASA 2 30

ASA 3 17

ASA 4 1

Smoking habits Smoker/Non-smoker 3/47

Type of stoma Colostomy 33

Ileostomy 8

Urostomy 9

Operating time (min) Mean (range) 110 (40-

377)

Blood loss (ml) Mean (range) 66 (0-750)

Postoperative stay (days) Median (range) 4 (1-22)

31

Table 6 Postoperative complications

Postoperative complication at one

month 16 (32%) Pneumonia and urinary tract infection 1

Wound infection 6

Deep infection 5

Postoperative intestinal obstruction 3

Prolapse of the stoma 1

Reoperation at one month 7 (14%) Mesh removed due to infection 2

Small bowel leakage 1

Laparotomy 3

Wound-incision due to infection 1

Reoperation at one year 5 (10%) Parastomal hernia recurrence 1

Small bowel obstruction 2

Incarcerated parastomal hernia 1

Ventral hernia (not related to the stoma) 1

Recurrence of parastomal hernia 11 (22%) Found clinically 11/50 (22%)

7 (15%) CT Found by CT 7/47 (15%)

Parastomal bulging found cliniclly 17/50 (34%)

Protrusion of stoma bowel found by CT 8/47 (17%)

n=50. CT was performed in 47/50 (three cases censored), thus n=47 regarding CT.

32

Study IV

Answers were obtained from 336 patients with and 117 without a stoma, resulting in a response rate of 46%

(453/986). Median follow-up time after rectal cancer surgery was 90.6 months (48-155) and median-age in

the responding group was 71 years (35-97). A slightly higher proportion of males (57.6%) answered the

questionnaires, which reflects the initial male/female distribution (55%/45%. Figure 3 illustrates the

distribution of responders for each QoL questionnaire.

The SF-36 and the EORTC QLQ-C30 are general QoL surveys and comparison between the groups with and

without stoma showed better mental health (MH; p=0.007), physical (PF; p=0.016) and emotional function

(EF; p=0.003) as well as slightly better global QoL (p=0.052) in the non-stoma group. The stoma group had

more pronounced fatigue (FA; p=0.019) and poor appetite (AP; p=0.027) and financial situation was to some

degree affected (FI; p=0.081). On the other hand, having an anastomosis (no stoma) gave rise to more

constipation (CO; p=0.017) and diarrhoea (DI; p=0.012).

Comparison with the “normal” Swedish population´s scores in SF-36 indicated that the non-stoma group

experienced similar QoL, except for items vitality (VT) and general health (GH), where the Swedish

background population scored higher. The stoma group scored generally lower than the “normal” population.

Both the stoma and non-stoma group had a lower QoL in the EORTC QLQ-C30 compared to the background

population.

Figure 3 Diagram showing distribution of responses for each QoL questionnaire

Although the perceived body image (BI; p<0.001) was inferior, sexual function (SX; p=0.034) was better in

the stoma group according to the EORTC QLQ-CR38. Answers to the CQ indicated negative impact on

sexuality (p=0.004) when having a parastomal bulging or hernia around the stoma, as well as impaired

psychological wellbeing (p=0.002). A hernia or a bulge around the stoma was associated with pain (p<0.001)

and fear for leakage from the stoma significantly (p<0.001) impaired the perceived function of the stoma.

Nearly one third (31.5%) of patients stated that they had a bulge or a hernia around the stoma, and almost

12% had been operated due to parastomal hernia. Stoma-related complaints forced more than 20% of the

stoma patients to seek acute medical care.

050

100150200250300350400450500

SF-36 EORTCQLQ C-30

EORTCQLQ-CR38

CQ Totalnumber of

patientsincluded

Stoma

Non-stoma

Total

33

Discussion and future aspects

Having a stoma affects QoL, and parastomal bulging or hernia further reduces the quality of daily life. Mesh

repair of parastomal hernia has the potential to be the method of choice, though with its high recurrence and

complication rate, the PHP does not seem to be optimal.

A stoma can be a saving factor in the critically ill patient, providing a temporary or definitive solution. A

stoma operation is often a planned procedure and something the patients have to live with for the rest of

their lives. Stoma complications and just adapting to the new situation affect the patient in many respects.

Care must be taken when constructing a stoma to assure good circulation and proper placement on the

abdominal wall. Parastomal hernia is a common complication where the true incidence is still a matter of

debate, reports in the literature range from a few percent up to 78%11,12. The patient experiences a bulging

around the stoma, which can complicate stoma dressings and increase the risk for leakage. A parastomal

hernia may lead to incarceration, necessitating emergency surgery. To clinically distinguish between a bulge

and a hernia is difficult19 but important as treatment of these two conditions differs.

Three-dimensional ultrasonography, an established technique in endo-anal and endo-rectal examinations,

has been further developed for examinations of stoma problms27. 3D US have been shown to provide the

ability to differentiate between a bulge and a hernia. In Study I in this thesis, the reliability of 3D US was

evaluated. The conclusion was that3D US has a reasonable learning curve and is a reliable method to

distinguish between a bulge and a hernia.

In that study, both an experienced and two less experienced investigators in assessment of endo-anal and

endo-rectal ultrasonography participated. To assess the learning curve, patients were consecutively divided

into groups; a baseline group of 20 patients followed by two groups of 10 making total of forty patients.

Doubts still exist as to whether or not the top of the learning-curve was actually reached since the inter-

observer reliability still differed between the last two groups. Kappa values may be calculated according to

Cohen, which measures nominal scale agreement between two fixed raters, or as Fleiss´, as in this study,

which measures agreement between more than two raters72. A Kappa-value of 0.7, rated as “substantial

agreement” (0.61-0.80), was reached in the last cohort, whereas the overall Kappa-value was 0.59 –

“moderate agreement”. This indicates a valid conclusion that the plateau of the learning curve had been

reached. Intra-observer agreement points in the same direction. The inclusion of both experienced and less

experienced raters in the study makes the results more trustworthy regarding generalisability.

Distinction between a hernia, a protrusion and a bulge was made when evaluating the images. The definition

of a hernia was a peritoneal sack with part of the bowel other than the stoma, or other intra-abdominal

content, such like fatty tissue or omentum, protruding out through the fascia-opening beside the stoma

(Figures 4 and 5). If excessive stoma-bowel was present in the subcutis or protruded out through the fascia

opening during Valsalva manoeuver, it was considered as a protrusion (Figures 6 and 7). A bulge, on the

other hand was an observed bulging of the abdominal wall but with no hernia or protrusion on 3D US. The

radiologic classification by Moreno-Matias et al, based on CT-scan, is quite similar73.

34

To further evaluate 3D US, a study was performed to assess its validity. In Study II the findings at 3D US and

abdominal CT were compared with each other and with the actual diagnosis made at surgery. This must be

regarded as a phase two study as only patients with pronounced symptoms requiring surgical intervention

Figure 6 Render mode 3D US image

showing protrusion of stoma bowel

Figure 7 Schematic illustration of

protrusion of stoma bowel

Muscle layer

Fascia

Skin

Figure 4 3D US image showing a

parastomal hernia

Figure 5 Schematic illustration of a

parastomal hernia

Skin

Parastomal hernia

Fascia

Parastomal hernia

Muscle layer

Stoma-bowel

35

were included making the expected rate of negative finding low. There was a high correlation between CT and

3D US findings expressed as sensitivity. The true specificity and negative predictive value, on the other hand,

cannot be established in this study due to the low rate of negative findings.

Comparison of findings by experienced radiologists and physicians performing 3D US is perhaps

questionable. All 3D US images were evaluated twice by doctors experienced in three-dimensional

ultrasonography, having performed and evaluated at least 50 3D-examinations before. In contrast to earlier

ultrasonography techniques, 3D US provides the possibility to store images for a second evaluation making it

equivalent to the CT-scan. It has been suggested that a higher sensitivity for parastomal hernia can be

achived with CT taken in the prone position22, but this technique requires a special protocol and in routine

practice CT is performed in the supine position.

Ultrasonography has the further advantage of not exposing the patient to irradiation, and 3D US is a

convenient and easily accessible method when used in direct association with the clinical examination. CT

may reveal a subclinical herniation74 that the 3D US probe might reduce. However, the use of a Valsalva

manoeuver will probably reduces that risk. On the other hand, the clinical impact of subclinical herniation is

probably not important8. To establish specificity and further evaluate 3D US, a study is planned where stoma

patients planned for abdominal surgery, with or without symptoms related to the stoma, will be included. In

conclusion, Studies I and II show 3D US to be a promising, reliable and valid tool to distinguish between a

bulge and a hernia.

As yet no technique has been shown to be superior in the treatment of parastomal hernia. The use of mesh

has been proposed as a promising option.

In Study III, a specially designed IPOM-mesh, PHP, was used treating in fifty consecutive patients being

operated for parastomal hernia. The pre-study clinical experience was good, and this was the first prospective

controlled study using this mesh. Results were disappointing with high recurrence rate, high reoperation rate

and a high complication rate. These results, however, do not differ from those most existing methods using

different forms of synthetic mesh. A known property of ePTFE is its tendency to shrink75 which may be one

explanation for parastomal hernia recurrences as the aperture of the mesh might increase. On the other

hand, shrinking could also result in a narrower aperture, which might have contributed to the complication

with strangulated bowel and subsequent leakage. There are concerns about PHP and similar prosthetic

materials, but these are still manufactured and thus this study is important. The use of ePTFE is debatedable,

but in a recent study, published in February 2015, ePTFE was used in open surgery for parastomal hernia

using the Sugarbaker technique76. This is a very small study, but it does confirm that ePTFE is still being used

for intra-abdominal implantation.

Fifty patients were consecutively recruited over a fairly long period of six years. In the first two years the

inclusion rate was higher, but then declined with time. A probable reason for this was the experience of

complications making the indication for surgery stricter as time progressed. A prospective non-randomised

study design was chosen to evaluate safety and recurrence rate, to be used as a base for future power

calculations as there was no available standard at that time. The study underlined the difficulty in

differentiating between a bulge and a hernia, with a clinical recurrence rate of 22%. Based on CT, the

recurrence rate was 15% and if a bulge was considered a hernia the corresponding rate was 34%.

With a 15% complication rate within one month, a 22% recurrence rate, and a 24% reoperation rate already

at one-year repair, PHP does not seem to be the optimal treatment for parastomal hernia. New mesh

materials are constantly being introduced. Early reports often show promising results but often with a short

follow-up time77. Hotouras et al conclude that large prospective controlled studies are required when

comparing surgical techniques78. Parastomal hernia has been described up to twenty years after the index

operation7. Biological implants are also promising, but studies have been small, often single-center, that

report favourable results 79. A problem is that these implants are expensive.

Mesh repair has become the gold standard in the treatment of incisional hernia. Aquina et al claim mesh to

be the gold standard treatment of parastomal hernias as well42. Fascia repair or relocation of the stoma

36

should be avoided due to the high recurrence rate. Mesh repair does seem to have potential to be the method

of choice. However, the most favourable placement of a mesh in the abdominal wall has yet to be determined.

Another key question is whether biological or synthetic material is the most suitable for parastomal hernia

repair. Both materials have shown promising results but biological material is very expensive. The patient´s

own tissue is another potential material that may be used. Obviously further studies in this field are required.

Good QoL is important and is a very personal experience. Tools currently available to assess HRQoL describe

what a group of patients experience and conclusions about QoL outcomes can be made on a group-basis.

However each patient is an individual and QoL depends on factors such as social, emotional, and religious

background as well as the society where he or she lives. Changes in life affect QoL and a cancer diagnosis

often changes the patient´s perspective fundamentally. If a person is cured of a potentially fatal disease he or

she might rejoice at having a new chance in life. Over time most people adapt to the new situation and

probably expect a good QoL.

After rectal cancer surgery nearly 50% of the patients4,80 end up with a permanent stoma and thus a

completely new situation in life. Stoma therapists play an important role in helping the patient to learn how

to change dressings and assist in individually fitting the stoma-dressing14. The fourth study focuses on the

HRQoL when living with a stoma after rectal cancer surgery. Earlier studies have shown QoL to be reduced in

stoma patients 16,31,81,82 with further reduction if there is a bulge or a hernia around the stoma6. The rate of

permanent stomas differs between regions in Sweden4 and some claim that patients with a stoma do not have

an inferior QoL. A Cochrane report from 2012 challenges the opinion that stoma patients have an inferior

QoL83 and calls for better prospective studies. That review included studies showing a better QoL among

stoma patients. In Study IV, QoL in patients with a stoma was lower than in patients not having a stoma after

surgery for rectal cancer. The fairly low response rate in this study must be taken in consideration. However,

all patients operated for rectal cancer between 1996 and 2004 in the catchment area and alive 2008 were

invited to participate. Other studies have often exclude patients with recurrent or metastatic disease or

patients who are expected to have difficulties understanding questions or the language.

Compared to normal Swedish population, the entire group operated for rectal cancer had an inferior QoL in

several respects, this being more pronounced among patients with a stoma.

In the stoma group, a bulge or a hernia around the stoma had additional impact on HRQoL and pain

associated with the stoma was significantly more pronounced in this group. Previous studies have shown sex

life and body image to be affected when having a stoma16,62,84,85. Stoma patients rated body image was rated

significantly inferior, and an expected consequence might be interference with sex-life, but this was not

shown in the present study. Patients without a stoma had significantly more sexual problems, which has also

have been shown in earlier studies86. On the other hand, a bulge/hernia in the stoma group was associated

with considerable sexual problems.

Previous studies have reported that a stoma affects the patient´s financial situation16. In our study the

financial situation only tended to be affected by having a stoma. Reasons for this might be taking time off

work due to visits to medical care and stoma-therapists, and the fact that 20% of stoma-patients needed

acute medical care due to the stoma. Having a stoma had a negative effect on appetite. The reason for this is

not known but it might depend on having to change the stoma dressing, and a feeling of being unclean.

Constipation and diarrhoea affected patients without a stoma more than stoma patients, in agreement with

the report by Digennaro et al85.

The incidence of parastomal hernia incidence has not been established and reports range between a few

percent to more than seventy11. In this cohort, the prevalence was at least 31.5%, though the true proportion

was probably higher as one third of the stoma patients did not answer that question. However, the true

prevalence was certainly not below 12% as 12% had been reoperated due to parastomal hernia. In this

reoperated group, half of the patients stated that they still had a bulge or a hernia which might correspond to

a recurrence of their parastomal hernia. Repair of recurrence of a previously operated parastomal hernia is

even more challenging, but there are few studies in the literature covering this aspect11.

37

In conclusion a stoma had a negative impact on overall QoL and a situation with a bulge or a hernia around

the stoma further aggravated this negative influence. Pain and sexual problems were more pronounced when

having a bulge/hernia, and fear for leakage from the stoma significantly impaired the patient´s perception of

function of the stoma. However, the fairly low response rate must be taken into consideration when

interpreting the results. The prospective collection of HRQoL data would probably give invaluable

information and should be given priority.

Improving the ability to correctly diagnose a parastomal hernia is essential, and 3D US is a promising

alternative to CT. In order to evaluate the negative predictive value of this technique, a larger study cohort in

need of surgery with or without s parastomal problem is planned.

None of the current methods used to treat parastomal hernia has shown to be superior. Recurrence and

complication rates are. Mesh repair is probably the most promising method, but we have still to find the most

suitable material and placement of the mesh. The PHP showed no advantage over other meshes. Future mesh

studies are needed, and promising materials include biological implants as well as implantation of

autologous tissue as prosthetic material.

The most appealing is to avoid parastomal hernia developing after the index operation. Studies on

prophylactic mesh have shown low parastomal hernia rates, but these studies are small with differing mesh

materials45. There are reports claiming no difference in rate of parastomal hernia with or without

prophylactic mesh46.Furthermore, the potential negative side effects have not been sufficiently evaluated.

Larger randomised studies are called for. STOMAMESH, a randomised controlled multicentre study

currently running in Sweden, randomises patients to prophylactic reinforcement with sub-lay mesh or not

when creating a permanent stoma. The inclusion goal will be reached during 2015 and a first report from

one-year follow-up data can be published in 2016. Beside the primary endpoint, parastomal hernia,

secondary end-points include mesh-related complications and HRQoL. A future study will involve plan in-

depth interviews using of qualitative methodology, and will include patients from the randomised cohort. We

hope this will further add to our understanding of the patient´s perspective.

A farm-worker impaled on a broomstick in 1750 was probably saved by the spontaneous development of a

stoma. The early days of were overshadowed by the enormous risk of fatal outcome, and in retrospect

enormous progress has been made in reducing risk, improving survival and reducing morbidity. Today a

stoma can be avoided in many cases, but is unavoidable in others. A stoma has great impact on the patient´s

life and in this thesis QoL was clearly shown to be reduced. HRQoL is important and must be taken into

account in all form of healthcare if we are to give the patient the best QoL possible. Hippocrates oath for good

medical care was stipulated centuries ago and a modern version states: “Never do harm, if possible cure,

often palliate and always comfort”. This must surely direct our choice of method for treatment and the use of

PHP does not fulfill these criteria. To find an effective low-risk treatment for parastomal hernia is of

paramount importance and this should be a field of research that is given high priority.

38

Acknowledgements

A PhD thesis is nothing one can accomplish without the support and help of others. I would like to thank all

those who gave me this vital endorsement and support.

Jörgen Rutegård; my first supervisor who persuaded me to start on this journey. You have been a great

support, believing in my ability when I doubted. AND Karin Strigård; my present supervisor who has always

been there to help and support. Thank you for all the stimulating conversations and sharing of thoughts over

meals.You have both given me critical feed-back and shared your knowledge while I climbed the learning

curve of scientific research.

Our research group, with Professor Ulf Gunnarsson as its founder, has beenan important forum for

challenging debate that has sharpened our arguments and objectives in the field of colo-rectal research. My

thanks go to all of you who participated in the meetings of this extraordinary group. Ulf – thank you for

inviting me to join this group. You have been one of my co-supervisors and I have really been impressed by

your capacity to maintain the focus of such a large group or workers, and remain always eager to help

whenever I send an e-mail.

Michael Dahlberg; co-supervisor and colleague. Thank you for making it possible for me to accomplish my

research in a reality where every-day work can be a great obstacle. You have given me time necessary for me

to reach the goal.

My co-writers Ambatchew Gurmu, Thyra Löwenmark, Ursula Dahstrand, Lars Påhlman and Franciska

Wikner; thank you all for your participation and fruitful discussions.

Research nurse Lisa Eskilsson. It was your appearance on the scene that actually gave me the strength to

continue my research. Thank you for being a phenomenal organiser and for all your thoughtfulness. When I

rushed into things you always came with a new point of view after taking a lot of aspects into consideration.

Robert Lundqvist. Statistics was a quite new area for me, and your knowledge is a bit more thorough than

mine – well actually you outclass me. But over the past few years I have learned a lot from you and you have

been a tremendous help with SPSS and work with the data-base – thank you!

An important base on which to build research is its economic funding. I would like to send a bunch of roses

to Karin Jones, head of the Centre for Research and Education (FoU) in Norrbotten and her co-workers. The

Centre provided economic funding for all the weeks designated for research and for the equipment, travels

and meetings necessary. Special thanks to Therese Sundbom and Annsofie Nilsson for all forms of

administrative help.

Eva Borin, my dear friend and former colleague. Your support throughout the years has been priceless.

Christoffer Odensten - thank you for being my co-worker and for all small-talk at numerous coffee breaks.

Ulf Öhrvall – thank you for your efforts to place research on the agenda at our department. I would also like

to take the opportunity to thank all surgical colleagues, nurses and all other personnel at Sunderby hospital.

Having close friends is a gift that gives strength and support in life. Bengt and Marie, Anders and Lena, Åsa

and Arne, Caroline and Martin, just to mention a few – I am grateful to each and everyone. A special thanks

to Jeanette Johansson, my close friend and Associate Professor, the Department of Business Administration,

LTU, for all “fika” small-talk and all scientific and work-related discussions.

Anna and Sune, my dear parents, without your support and trust in my ability, I would probably not have

become what I am today. Åsa and Pär and your families are very important to me. Birgit and Kenneth I know

I always can come to you with my worries and happiness. Thank you all! Finally, Erik, Emil, Johan, Oskar

and Olof – you are the joy and most important part of my life. I know I probably work too much, and I know I

am often away from home – thank you for accepting this and letting me take the time to complete my thesis.

1

2

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