How to Prevent Tissue Adhesions in Gynaecological Endoscopic Surgery .pdf

UNIVERSITÄTSKLINIKUM

Schleswig-Holstein

Campus Kiel

KIEL SCHOOL // Zertifiziertes Ausbildungszentrum der AGE

How to prevent tissue adhesions in

gynecological endoscopic surgery

Liselotte Mettler Department of Obstetrics and Gynecology

Kiel School of Gyne. Endoscopy

University of Schleswig-Holstein,Campus Kiel

Kiel, Germany

“ [email protected]“


Schleswig-Holstein

Campus Kiel


From Kiel,

Germany

To

Singapore

SICOG 2013


Schleswig-Holstein

Campus Kiel


Adhesions:

Do we need to prevent?

Yes!

Do we need to treat?

Yes?


Schleswig-Holstein

Campus Kiel


Paradox of surgery

The method proposed to treat adhesions is the one that induces

adhesions.

Need for clinical & cost-effective agents

to reduce adhesion development


Schleswig-Holstein

Campus Kiel


Formation of Adhesions

Bleeding

Adhesions

Injury

Fibrindeposition

Inflammation

Steps to reduce adhesions

during surgery

•Increase vascular permeability

•Reduce infection risk

•Minimize tissue handling

•Careful technique

•Microsurgery

•Reduce drying of tissues

•Lubrication

•Limit use of cautery

•Limit use of sutures

•Avoid materials with fibres

•Use starch-free gloves


Schleswig-Holstein

Campus Kiel


Steps to reduce adhesions

Careful surgical technique

Minimize inflammatory response

Augmentation of fibrinolysis

Adhesion-reduction agents


Schleswig-Holstein

Campus Kiel


Applying adjuvants: solutions / drugs

NSAIDs Non steroidal Anti inflammatory Disease agents

Most widely studied; clinical efficacy is questionable

Corticosteroids

Poor efficacy; associated with immunosuppression and delayed wound healing

Fibrinolytics

Risk of impaired wound healing and/or bleeding

Risberg B. Eur J Surg Suppl. 1997


Schleswig-Holstein

Campus Kiel


Adhesion Reduction Agents: The ideal agent

Safety

Easy to use

General surgery

Gynaecological surgery

Open

Laparoscopic

Efficacy

Operation site

Throughout the cavity

Economical

ESHRE 2002 Survey, EACP 2002 Survey

According to recent surveys of surgeons the four key attributes are:


Schleswig-Holstein

Campus Kiel


Adhesion Reduction Agents

Site Specific

Preclude* expanded polytetrafluoroethylene Gore-Tex sheet Generally unavailable

Interceed oxidised regenerated cellulose

fabric

Seprafilm hyaluronic acid carboxymethylcellulose

film

SprayGel/Shield polyethylene glycol

hydrogel

SurgiWrap copolymer 70:30 Poly(L-lactide-co-D, L-lactide) sheet

Hyacorp endogel Cross linked Sodium hyaluronate

Intercoat Polyethylen oxide (PEO) /sodium carboxymethyl cellulose (CMC), 30 days to clear the

peritoneal cavity

Broad Coverage

Crystalloids Ringer’s lactate/saline +/- Heparin

Hyskon 32% dextran 70 solution Generally unavailable

Sepracoat 0.04% hyaluronic acid-phosphate-buffered saline Withdrawn

Intergel 0.5% ferric hyaluronate gel Withdrawn

Adept icodextrin 4% solution


Schleswig-Holstein

Campus Kiel


Most Widely Used Adhesion Prevention Adjuvants

Crystalloid instillates

Lactated Ringer’s

Saline

Hartmann’s Solution

Limitations:

Absorbed within 24 hours

They don’t prevent adhesions!


Schleswig-Holstein

Campus Kiel


Interceed Barrier(Oxidized Cellulose, Gynecare)

First FDA approved adhesion reduction adjuvant

Most clinical studies (24)

Widely applicable

all intraperitoneal locations

all surgical procedures

Compatible with laparoscopy

Limited use in colorectal surgery

Limitations:

Blood oozing renders it ineffective

Irrigants must be removed

Technical application challenges!


Schleswig-Holstein

Campus Kiel


Seprafilm Membrane (HA+CMC, Genzyme)

Widely applicable

covers all intraperitoneal locations

all surgical procedures

Used in general surgery

Limitations:

Handling

Residual irrigation fluid must be removed

Cannot be used via laparoscopy

Cost!!

Beck et al Dis Colon Rectum 2003;46:1310-1319


Schleswig-Holstein

Campus Kiel


Polymerization

Methylene blue to show where it is used

SprayGel / Shield (Polyethylene Glycol Polymer, Confluent)


Schleswig-Holstein

Campus Kiel


Laparoscopic Kit

Requires specialised air pump



Schleswig-Holstein

Campus Kiel


SprayShield(Polyethylene Glycol Polymer, Covidien)

Limitations

complex set-up

time consuming

cost……


Schleswig-Holstein

Campus Kiel


Adept®

- new solution to adhesion reduction?


Schleswig-Holstein

Campus Kiel


Adept - icodextrin 4% solution

1,4 linked glucose polymer

Icodextrin 4% solution

isosmolar

biocompatible

well-established safety profile at 7.5% concentration

>36,000 patient years safety data from renal use

~50,000 patients treated with Adept

persists in peritoneal cavity

reduces adhesion formation through physical action

‘hydroflotation’


Schleswig-Holstein

Campus Kiel


Adept hydroflotation mechanism

Residual Volume in Abdomen

0

500

1000

1500

2000

2500

0 20 40 60 80 100 120

Time (hours)

ml

4% icodextrin

Saline

Glucose


Schleswig-Holstein

Campus Kiel


Adept use

Irrigation

minimum 100ml / 30min

Laparoscopy through the scope

Laparotomy via a syringe

Instillation

1000 ml at closure


Schleswig-Holstein

Campus Kiel


Adept (Icodextrin 4%, Baxter Pharmaceuticals)

Covers all intraperitoneal locations

Easy to use

laparotomy registry feedback

Not constrained by oozing

Residual irrigation solution is not a problem

Extensive safety experience at 7.5%

ARIEL Registry of routine use in >4,600 patients

feedback of use and safety good

Modest cost

The first powered RCT providing evidence for the use of Adept for adhesion prevention

Brown et al.: Adept reduces adhesions after laparoscopic surgery...Fertil Steril (2007) 88:1413-26


Schleswig-Holstein

Campus Kiel


HYA corp ENDO GEL cross linked Sodium

hyaluronate

• Reduces adhesion formation particularly after peritoneal defects

which provoke normally severe adhesion formation with pain and

sometimes bowel obstruction.

• Mettler et al. MITAT, 2013 online published


Schleswig-Holstein

Campus Kiel


Adopt use of anti-adhesion agents in ‘High Risk’ surgery

• Myomectomy

Suturing and Spray Shield or easier and cheaper Hya-Corp

endogelPeriovarian Adhesions

Remove the ovaries out of this field

Spray Shield or easier and cheaper Hya-Corp endogel in

fossa ovarica

Endometriosis

Adept and Hya-Corp endogelAdhesiolysis

Adept and Hya-Corp endogel

• Easy to use in open surgery, caesarean section,

oncology,etc.


Schleswig-Holstein

Campus Kiel


Surgical procedures and adjuvant use

Adhesion

Type

Fertility Surgery Gynaecology General

Surgery

De

novo

Reform Open Laparoscope Open Scope Open Scope

Uterus Adnexa Uterus Adnexa Uterus Adnexa Uterus Adnexa

Site

Specific

Preclude +++ +++ √ X X X √ X X X √ X

Interceed +++ +++ √ √ √ √ √ √ √ √ O O

Seprafilm +++ +++ √ X X X √ X X X √ X

SprayGel +++ +++ √ √ √ √ √ √ √ √ ? ?

SurgiWrap ? ? ? ? ? ? ? ? ? ? ? ?

Broad

Coverage

Hyskon ++ ++ O O O O O O O O O O

Sepracoat ++ ++ Withdrawn

Intergel +++ +++ Withdrawn

Adept +++ +++ √ √ √ √ √ √ √ √ √ √

O = not used/recommended


Schleswig-Holstein

Campus Kiel


Informed consent

• International Adhesions Society Patient Survey*

• In only 10.4% of cases are adhesions mentioned as part of informed

consent process

• In 14.4% of cases adhesions discussed but not part of consent

• Adhesiolysis patients

• 54% given some information before surgery

• 46% given specific information about anti-adhesion agents

• In non-adhesiolysis procedures only 10% patients advised about

adhesions

• Only 6% given information on anti-adhesion agents

Wiseman, Adhesions News & Views 4 2003 and PAX Meeting 2003


Schleswig-Holstein

Campus Kiel


Adhesions are inevitable

High risk of adhesion-related problems

• Small bowel obstruction

• Female infertility

• Chronic and debilitating pelvic pain

• Reoperative complications

Do we tell our patients when we obtain consent?


Schleswig-Holstein

Campus Kiel


Adoption of routine prophylaxis

depends on impact of strategy on

adhesion-related readmissions

and cost of strategy

Prophylaxis?


Schleswig-Holstein

Campus Kiel


Cost-effectiveness

Menzies, Parker et al. Ann Roy Coll Surg Engl. 2001

Costs of adhesion-related Small Bowel Obstruction

Conservatively treated £1,606 (mean stay 7 days)

Surgically treated £4,677 (mean stay 16 days)

Adhesion reduction technologies may reduce costs


Schleswig-Holstein

Campus Kiel


Influence of surgery – It's our job

reduce coagulation

reduce bleeding

perform a good approximation (peritoneum)

reduce the use of drainage

Some examples ...


Schleswig-Holstein

Campus Kiel


Paracervical Fibroid


Schleswig-Holstein

Campus Kiel


Laparoscopic supracervical hysterectomy (LASH)


Schleswig-Holstein

Campus Kiel


Myomectomy – anterior wall and fundus uteri


Schleswig-Holstein

Campus Kiel


Myomectomy – posterior wall left side


Schleswig-Holstein

Campus Kiel


Myomectomy – posterior wall left side


Schleswig-Holstein

Campus Kiel


Adhesiolysis


Schleswig-Holstein

Campus Kiel


Role of laparoscopy in identifying the clinical significance and cause of

adhesions and chronic pelvic pain: a retrospective review at the Kiel School of

Gynecological Endoscopy.JSLS 2007; 11:303-308

L. Mettler and M. Al Hujeily


Schleswig-Holstein

Campus Kiel


Table 1. Reason for admission vs. presence of adhesions among all patients (n = 462)

Reason for Admission Vs. Presence of Adhesions

Presence of AdhesionsTotal

Yes No

Reason for

Admission

Ovarian Surgery 94(34.2%) 61(32.6%) 155(33.5%)

Pelvic Pain 84(30.5%)* 22(11.8%) 106(22.9%)

Myomectomy 37(13.5%) 44(23.5%) 81(17.5%)

Infertility 29(10.5%) 21(11.2%) 50(10.8%)

Tubal Surgery 17(6.2%) 21(11.2%) 38(8.2%)

Hysterectomy 9(3.3%) 7(3.7%) 16(3.5%)

Rest of Procedures 5(1.8%) 11(5.9%) 16(3.5%)

Total 275(100%) 187(100%) 462(100%)

* P < 0.0005


Schleswig-Holstein

Campus Kiel


Table 2. Relation between timing and type of the previous surgery among all patients with adhesions (n = 193).

Time Interval of Previous

Surgery Total

0-5 yrs 5-10 yrs > 10 yrs

Past

Surgical

History

> One Previous

Surgery9(4.7%) 4(2.1%)

56(29.0%)

*69(35.8%

)

Appendectomy 2(1.0%) 3(1.6%) 47(24.4%)52(26.9%

)

Myomectomy 7(3.6%) 3(1.6%) 5(2.6%) 15(7.8%)

Diagnostic

Laparoscopy6(3.1%) 3(1.6%) 4(2.1%) 13(6.7%)

Ovarian Surgery 2(1.0%) 2(1.0%) 7(3.6%) 11(5.7%)

Tubal Ligation 1(0.5%) 2(1.0%) 4(2.1%) 7(3.6%)

Hysterectomy 1(0.5%) 1(0.5%) 3(1.6%) 5(2.6%)

Ectopic Pregnancy 1(0.5%) 0(0.0%) 3(1.6%) 4(2.1%)

Other Surgical

Procedures1(0.5%) 3(1.6%) 13(6.7%) 17(8.8%)

Total30(15.5

%)

21(10.9

%)

142(73.6

%)

193(100

%)

*P < 0.0005


Schleswig-Holstein

Campus Kiel


Table 3. Relation between timing and type of the previous surgery among patients with pelvic pain.

Time Interval of Previous Surgery

Total1-5 yrs

5-10

yrs> 10 yrs

Past

Surgical

History

> One Previous Surgery 7(10.4%) 1(1.5%) 25(37.3%) 33(49.3%)

Appendectomy 2(3.0%) 0(0.0%) 9(13.4%) 11(16.4%)

Myomectomy 2(3.0%) 1(1.5%) 2(3.0%) 5(7.5%)

Tubal Ligation 1(1.5%) 1(1.5%) 3(4.5%) 5(7.5%)

Diagnostic Laparoscopy 1(1.5%) 0(0.0%) 2(3.0%) 3(4.5%)

Ovarian Surgery 1(1.5%) 0(0.0%) 1(1.5%) 2(3.0%)

Hysterectomy 1(1.5%) 0(0.0%) 0(0.0%) 1(1.5%)

Other Surgical

Procedures0(0.0%) 1(1.5%) 6(9.0%) 7(10.4%)

Total 15(22.4%) 4(6.0%) 48(71.6%) 67(100%)


Schleswig-Holstein

Campus Kiel


Figure 1. Reason for admission vs. presence of adhesions among all patients (n = 462)


Schleswig-Holstein

Campus Kiel


Site of Adhesions

Multi Sites

Pelvis

Mid Abdom

en

UpperAbdomen

Co

unt

50

40

30

20

10

0

Type of Adhesions

Thin

Thick

P <

0.005

Figure 3. Relation between the type and site of adhesions among patients with chronic pelvic pain


Schleswig-Holstein

Campus Kiel


Let me report on 4 studies, we performed, investigating adhesion reducing agents

1.COSEAL (BAXTER)2.ADEPT (BAXTER)

3. SPRAY SHIELD (COVIDIEN)

4. HYA Corp Endogel(BIO SCIENCE)


Schleswig-Holstein

Campus Kiel


Adhesion Prevention - Does it work?

Objective of the study:

The management of fibroids and the surgical

treatment of endometriosis is closely related to adhesion

prevention, as consecutive adhesions may hinder the

desired aim of the surgery

pain relieve, fertility and conception as much as the

fibroid or endometriosis


Schleswig-Holstein

Campus Kiel



Material and Methods:

In two randomised controlled studies with

SprayShield (COVIDIEN BioSurgery) former SprayGel

and Adhibit/COSEAL (BAXTER) and in one double-

blind randomised controlled study with Adept (

Baxter)

the potential efficacy of the barrier gels and Adept

(0,4% icodextrin solution) to reduce post-operative

adhesions was evaluated.


Schleswig-Holstein

Campus Kiel




After the initial myomectomy or endometrioma

enucleation by operative laparoscopy in trial and control

patients, a second-look laparoscopy was performed 6 –

8 weeks after the primary surgery to assess the

incidence of new adhesions, their extent and their

tenacity score.


Schleswig-Holstein

Campus Kiel


COSEAL


Schleswig-Holstein

Campus Kiel


Human Reproduction Vol. 23, No. 5, pp. 1093-1100,

2008

COSEAL

A Safety and Efficacy Study of a Resorbable Hydrogel for Reduction of Postoperative Adhesions Following

Myomectomy

Running title: Hydrogel for Adhesion Reduction Post-Myomectomy

L. Mettler, MD, PhD (1); J. Hucke, MD, PhD (2); B. Bojahr, MD, PhD (3);

H.-R. Tinneberg, MD, PhD (4); N. Leyland, MD (5); R. Avelar, MD (6)


Schleswig-Holstein

Campus Kiel


COSEAL -Adhesion Prevention Gel

Component 1

Component 2

PEG Solution

BackboneBuffer

In Situ Polymerization

FLUI

D


Schleswig-Holstein

Campus Kiel



Schleswig-Holstein

Campus Kiel


49

Pre-clinical Safety and Effectiveness Studies

Effectiveness

- Complete

Studies provide evidence that

COSEAL group performed better

than Control group in adhesion

prevention

Safety

- Complete

Cytotoxicity

Sensitization

Implantation

Toxicity

Genotoxicity

ADME Biodegradation

Safety (Pre-Clinical)

- Complete

Reproductive Toxicity (IDE)

Infection Potentiation (IDE)


Schleswig-Holstein

Campus Kiel


Table I: Modified AFS Scoring Method for Adhesions

Finding mAFS Score

Severity Grade

Tenacity None, Extent None 0 None

Tenacity Filmy, Extent < 25% 1 Mild

Tenacity Filmy, Extent 25 – 50% 2 Mild

Tenacity Filmy, Extent 51% 3 Moderate

Tenacity Dense, Extent < 25% 4 Moderate

Tenacity Dense, Extent 25 – 50% 5 Severe

Tenacity Dense, Extent 51% 6 Severe

mAFS=modified American Fertility Society


Schleswig-Holstein

Campus Kiel


51

COSEAL(ITT)

Control(ITT)

P-value*

Primary surgery 0.5 ±1.4

(N=48)

0.0±0.0

(N=23)

0.140

Second-look 1.1±1.9

(N=38)

2.6±2.2

(N=20)

0.024

Change from baseline

0.8±2.0

(N=38)

2.6±2.2

(N=20)

0.010

Change from baseline, p-value

0.014 < 0.001

Mean mAFS at the Posterior Uterus Site

Cohesion Myomectomy Study

* ANOVA p-values


Schleswig-Holstein

Campus Kiel


52

1st Surgery

COSEAL(N=38)

Control(N=20)

P-value*

None 92.1% (35) 100.0% (20) 0.2086

< 25% 2.6% (1) 0.0% (0)

25-50% 5.3% (2) 0.0% (0)

> 51% 0.0% (0) 0.0% (0)

2nd Surgery

None 65.8% (25) 35.0% (7) 0.0277

< 25% 21.1% (8) 30.0% (6)

25-50 % 5.3% (2) 30.0% (6)

> 51% 7.9% (3) 5.0% (1)

Extent Score at the Posterior Uterus Site


* Mann-Whitney test p-values


Schleswig-Holstein

Campus Kiel


53


2nd SurgeryCOSEAL(N=38)

Control(N=20)

P-value*

Adhesions 34.2% (13) 65.0% (13) 0.0245

No

adhesions

65.8% (25) 35.0% (7)

* Likelihood-ratio chi-square test p-value (two-sided)

Incidence of Adhesions at the Posterior Uterus Site


Schleswig-Holstein

Campus Kiel


54

Effectiveness Assessment

71% of COSEAL subjects were treated at < 3 of the 15 pelvic

sites.

The vast majority of sites compared between COSEAL and

control were not treated with COSEAL.

However,

Most incisions were located at the posterior uterus from

myoma removal (84.5%)

Almost all randomized COSEAL subjects (47 of 48) received

COSEAL on the posterior uterus

Therefore the primary and secondary endpoints were redirected

to the posterior uterus only.

Coseal Myomectomy Study


Schleswig-Holstein

Campus Kiel



Results:

Adhibit (COSEAL) applied under air pressure shows a good

trend towards adhesion prevention (>65% efficacy

As the drug went from Cohesion to Angiotech and now to Baxter

as Coseal, which was the original name , the company

plans a new promotion.

Table 3

Adhesion scores exspressed in severity – extent and

incidence (0 – 3) after endoscopic surgery in a second

look endoscopic evaluation


Schleswig-Holstein

Campus Kiel


ADEPT and GENEVA STUDY


Schleswig-Holstein

Campus Kiel


ADEPT and GENEVA STUDY

The Geneva study with Adept has demonstrated with us so far

ONLY in endometrioma surgery a certain adhesion reduction (65%

efficacy).


Schleswig-Holstein

Campus Kiel


Adept and its efficacy

The only statistical differency in a

comparison of Adept to Ringer‘s

lactate was the really better

adhesion protective effect on the

posterior side of the uterus

G. Trew , G. Pistofidis, G. Pados,A. Lower, L. Mettler, D.

Wallwiener et al, Human Reproduction, 2011, Vol.

26,8


Schleswig-Holstein

Campus Kiel


Adept®

- new solution to adhesion reduction?


Schleswig-Holstein

Campus Kiel


Adept - icodextrin 4% solution

1,4 linked glucose polymer

Icodextrin 4% solution

isosmolar

biocompatible

well-established safety profile at 7.5% concentration

>36,000 patient years safety data from renal use

~50,000 patients treated with Adept

persists in peritoneal cavity

reduces adhesion formation through physical action

‘hydroflotation’


Schleswig-Holstein

Campus Kiel


Adept hydroflotation mechanism

Residual Volume in Abdomen

0

500

1000

1500

2000

2500

0 20 40 60 80 100 120

Time (hours)

ml

4% icodextrin

Saline

Glucose


Schleswig-Holstein

Campus Kiel


Adept use

Irrigation

minimum 100ml / 30min

Laparoscopy through the scope

Laparotomy via a syringe

Instillation

1000 ml at closure


Schleswig-Holstein

Campus Kiel


Adept (Icodextrin 4%, Baxter Pharmaceuticals)

Covers all intraperitoneal locations

Easy to use

laparotomy registry feedback

Not constrained by oozing

Residual irrigation solution is not a problem

Extensive safety experience at 7.5%

ARIEL Registry of routine use in >4,600 patients

feedback of use and safety good

Modest cost

The first powered RCT providing evidence for the use of Adept for adhesion prevention

Brown et al.: Adept reduces adhesions after laparoscopic surgery...Fertil Steril (2007) 88:1413-26

Trew et al: GENEVA Study Human Reproduction, Vol 26, 8, 2011


Schleswig-Holstein

Campus Kiel



Schleswig-Holstein

Campus Kiel



Schleswig-Holstein

Campus Kiel


SPRAY SHIELD


Schleswig-Holstein

Campus Kiel


Mettler L, Audebert A, Lehmann-Willenbrock E, Schive-Peterhansl K, Jacobs VR.

A randomized, prospective, controlled, multicenter clinical trial of a sprayable, site-specific adhesion barrier system in

patients undergoing myomectomy.Fertil Steril. 2004; 82(2): 398-404.


Schleswig-Holstein

Campus Kiel


Current uses of PEG

in the body

• Eye drops

• Pharmaceuticals

• Injectables

• Surgical sealants

Route of clearance

• Kidneys, excreted in urine

Polyethylene glycol (PEG)

Time (hours)

0

20

40

60

80

100

Perc

ent

rem

ain

ing

0 1 2 3 4 5 6 7

Absorption over 7 days

Then rapid systemic clearance

I-labeled

20k MW PEG

125

Yamaoka, et al: J. Pharm. Sci.,

Vol 83, No. 4, Apr 1994, p 601


Schleswig-Holstein

Campus Kiel


69

66

3

2

64

54 10

26 C 28 T 4 C 6 T

N=18/30 C

60%

N=22/34 T

64,7%

Number of patients enrolled

withdrawn

Number of patients

in safety evaluation

Excluded prior randomization

Training patients

(one at each site)

(patients who were from the study)

Number of patients randomised and

included in efficacy evaluation

University Frauenklinik

(OB/GYN) Kiel Bordeaux Clinic

Randomization

distribution

(C=control,

T=treatment)

Returned second-look

laparoscopy

Flow Chart:

Distribution of Patients in the SprayShield Trial


Schleswig-Holstein

Campus Kiel


Treated Group (ÒTÓ) SD Control Group (ÒCÓ) SD

Randomized [n] 34 30

Mean Age [years] 34.9 (28-52) 5.2 35.0 (23-45) 5.9

Mean Height [cm] 168.6 (157.0-179.0) 5.7 168.5 (155.0-180.0) 6.8

Mean Weight [kg] 64.8 (49-90) 9.5 63.6 (44-92.5) 11.8

Prior Myomectomy [n] 5 (14.7%) 1 (3.3%)

Prior Adhesiolysis [n] 3 (8.8%) 0 (0.0%)

Primary Cause of Surgery:

Infertility [n] 11 (32.4%) 9 (30.0%)

Pain [n] 16 (47.1%) 16 (53.3%)

Other [n] 7 (20.6%) 5 (16.7%)

Leiomyoma removed:

Mean Number [n] 2.6 (0-18) 3.2 2.6 (0-14) 3.2

Mean Weight [g] 115.0 (0-452) 121 101.1 (0-520) 104

Uterine Incisions:

Mean Number [n] 1.9 (1-8) 1.5 1.5 (1-6) 1.2

Mean length [cm] 7.4 (3-28) 4.9 7.0 (3-26) 4.6

Completed Second-LookLaparoscopy [n]

22 (64.7%) 18 (60.0%)

Patient Demographics

for Treatment and Control Groups


Schleswig-Holstein

Campus Kiel


Schedule of Events

Informed Consent

Medical History

Physical Exam

Pregnancy Test

Patient Weight

Adverse Events

Concomitant

Medication

Health questions

Blood Chemistry

Urinalysis

Pre-

Op

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Phon

e call

2nd Look

Laparosco

py

Exam

Discharg

e


Schleswig-Holstein

Campus Kiel


Polymerization

Methylene blue to show where it is used



Schleswig-Holstein

Campus Kiel


Laparoscopic Kit

Requires specialised air pump

SprayGel / Shield (Polyethylene Glycol Polymer, COVIDIEN)


Schleswig-Holstein

Campus Kiel


SprayShield(Polyethylene Glycol Polymer, Covidien)

Limitations

complex set-up

time consuming

cost……


Schleswig-Holstein

Campus Kiel



Schleswig-Holstein

Campus Kiel



Schleswig-Holstein

Campus Kiel



Schleswig-Holstein

Campus Kiel



Schleswig-Holstein

Campus Kiel



Schleswig-Holstein

Campus Kiel



Both adhaesion barrier gels

SpryShield and Coseal were

safe,well tolerated and

demonstrated efficacy in a

population of patients at risk for

adhesion formation.

Adept -was safe AND WAS

APPLIED WITHOUT SIDE

EFECTS

Mettler et al. Fertil,Steril.

2004

Mettler et al. Human

Reproduction, 2008

Trew et al. Human

Reprod.2011


Schleswig-Holstein

Campus Kiel


HYA corp Endo Gel


Schleswig-Holstein

Campus Kiel


HyaCorp Endo Gel

Represents a Hyaluronic Acid (HA) and sodium

carboxymethylcellulose (CME) lyophilized solution crosslinked with

1.ethyl-3-(3-dimethylaminopropyl) carbodiimide

which proved to be an excellent Anti-Adhesion Barrier Gel in animal

studies since 5 years :

Sang-Mook Lee et al. The effects of Hyaluronic acid-

carboxymethylcellulose membraner (Guardix-MB) barriers on

prevention of post-operation peritoneal adhesions : Vet. Clin

25,6:494-500,2008 - (mongrel dogs)

Hye Seong Ahn et al. Efficacy of an Injectable Thermosensitive Gel

on Postoperative Adhesion in Rat Model J. Korean Surg Soc.

79,239 – 245, 2010


Schleswig-Holstein

Campus Kiel


Hya Corp ENDO GEL

Is accredited in Europe (CE0297) and is at present used in clinical

studies

-- At the Dept. Obstet Gynec. Univ. Kiel, GERMANY ( n=120 )

-- At the German Medical Center, Dpt. Obstet. Gynecology, Dubai,

Healthcare City ( n= 50)

--The gel is easy to apply, through a simle applicator introduced

through the 5 mm trocar , with simple mechanical pressure.

No side effects were observed.

-- 35 patients had a second look laparoscopy within 8 weeks and

showed no adhesions on the suspected areras.


Schleswig-Holstein

Campus Kiel


Cross-linked sodium

hyaluronate, an anti-adhesion

barrier gel in gynecological

endoscopic surgery,

Mettler, L.epub. MITAT,2013


Schleswig-Holstein

Campus Kiel


Abstract

Objectives:

In the context of common adhesion prevention in laparotomic,

laparoscopic and hysteroscopic surgery this article details the effects of

a cross-linked sodium hyaluronate anti-adhesion barrier gel. The

observed adhesion score is expressed in the following threee

measurements: severity, extent and incidents of adhesions.


Schleswig-Holstein

Campus Kiel



From a total of 85 patients treated by laparoscopy or hysteroscopy

,where HYA CORP Endo Gel was applied, a

second look endoscopic procedure could be performed in 35 cases.

Results

Our preliminary, short evaluation of 35 patients submitted to a second

look laparoscopy or hysteroscopy revealed the beneficial effect of the

applied HYAcorp Endo Gel, showing only a minimal amount of

adhesions at the second look observation.


Schleswig-Holstein

Campus Kiel


Conclusion:

Cross-linked sodium hyaluronate is highly effective in the prevention of

adhesions at laparoscopic and hysteroscopic surgery.


Schleswig-Holstein

Campus Kiel


Schematic presentation of genital adhesiolysis via laparoscopy

180 x 157 mm (300 x 300 DPI)


Schleswig-Holstein

Campus Kiel


Consequences of operative injury

254 x 190 mm (96 x 96 DPI)


Schleswig-Holstein

Campus Kiel


Table 1

Adhesion prophylaxis in 85 gynaecological endoscopic cases (2011 –

2012)

Laparoscopies n

Myoma enucleations

Endometriomas

Ovarian Cysts

Hysterectomies (TLH)

24

16

20

15

Total 75

Hysteroscopies n

Septum resections

Myoma enucleations

5

5

Total 10


Schleswig-Holstein

Campus Kiel


Table 2: Qualitative and quantitative composition of HYAcorp endo gel

1ml of HYAcorp endo gel contains:

Na-hyaluronate, cross-linked hylan gel 20 mg

Na-hyaluronate 10 mg

Sodium chloride 6,9 mg

Water for injection add 1 ml


Schleswig-Holstein

Campus Kiel


Table 3

Adhesion scores exspressed in severity – extent and incidence

(0 – 3) after endoscopic surgery applying Hyacorp endogel in a

second look endoscopic evaluation


Schleswig-Holstein

Campus Kiel


Experience of using Hya Corp Endo Gel in

Gynaecology OPEN Surgery

• 1. Caesarian sections

• 2. Oncology Surgery as ovarian cervial and uterine

cancer

• 3. Laparotomy for large fibroids, bowel re-section and

endometrosis.

• 4. Paragynaecological procedures : Appendectomy,

adhesionlysis and etopic pregnancy treatment.


Schleswig-Holstein

Campus Kiel


Summary for the studies on Adhesesion prevention

with Hydro Gels and Hydro Flotation

The formation of postoperative adhesions is a significant

cause of morbidity and burdens healthcare systems and even

best surgical practise cannot avoid adhesion format

SprayShield™ is a site-specific adhesion barrier that

polymerizes within seconds of spraying it on tissues and

protects tissues from adhesion formation while the tissues

heals, it allows immediate irrigation.

The blue colorant of the SprayShield™ barrier enables the

surgeon to visualize the area of application for better cont


Schleswig-Holstein

Campus Kiel


Summary for the studies on Adhesesion prevention

with Hydro Gels and Hydro Flotation

An equivalent adhesion barrier is COSEAL, with no coulor for vision

The hydroflotation principle od ADEPT is very good but should best

be used in a combined approasch with PEG’s or the absorbable ant-

adhesion barrier on “hyaluronidase basis” Hya-Corp endogel.

Hya-Corp endogel is a potent physical barrier

against the contact between adjacent tissues for at least 7 days.


Schleswig-Holstein

Campus Kiel


Adhesions - can we prevent or attack

them??

Yes we can by

1. careful, good surgery, preventing larger traumas, infection ,

irritation spilling and immune response

2. adhesion prevention with PEG‘s may be improved by adding

medications

3. The rinsing solution „Adept“ is complimentory to PEG‘s and

substitute Ringer‘s lactate to optimize a full concept of

surgical adhesion prevention

4. Hya-Corp endo gel , obtained by crosslinking special

designed hyaluronic acid , is a promising new agent and

may also be combined with ADEPT

,


Schleswig-Holstein

Campus Kiel


Literature of Liselotte Mettler

over 500 publications, 20 text books

• 1. From air insufflation to robotic endoscopic surgery: a rocky

road. Mettler L. J Minim Invasive Gynecol; 2011 May-

Jun;18(3):275-83.

the AAGL journal

• 2. Practical Manual for Laparoscopic and Hysteroscopic

Surgery

( Atlas and textbook with 32chapters and integrated DVD’s )

Schollmeyer, Th, Mettler, L, Ruether,D. and I. Alkatout

Jaypee Broth. 2012


Schleswig-Holstein

Campus Kiel



Schleswig-Holstein

Campus Kiel


Vielen Dank to

SICOG 2013

SKIN MD PTE LTD

&

MEDICAL REVOLUTION TECHNOLOGY

The End

Date post:	07-Feb-2016
Category:	Documents
Upload:	hector-cordero
View:	41 times
Download:	2 times

How to Prevent Tissue Adhesions in Gynaecological Endoscopic Surgery .pdf

Documents