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EndoTHeF: Endovascular Treatment of
Hemorrhoids with Foam
M. Ronconi, M.D.
E. Cervi, M.D.
A. Frullini, M.D.
XVII°World Meeting
of the
Union Internationale de Phlébologie
Polidocanol foam as referred to in this talk
has not been approved for use by the
Federal Drug Administration (FDA).
Disclosure of
conflicts of interest
I do not have any relevant financial relationships with any commercial interests.
Disclosure of non-FDA
approved drugs
Maurizio Ronconi, M.D.
• Haemorrhoids are normal anatomical structures present in healthy
people from birth, recognizable even in uterine life.
• When these vascular cushions generate symptoms, we erroneously
speak of “haemorrhoids”
When we use the term “haemorroids” we
generally refer to the symptoms caused by
haemorrhoids
Misunderstanding
• Bleeding, anemization
• Prolapse
» ulceration
»sepsis
»strangulation
• Pain
• Thromboflebitis
• Pruritus
Most frequent symptoms
Epidemiology
Western countries:
- 5% of the whole population is affected by haemorrhoids
USA:
- 10 million people complained of haemorrhoids, leading to
a prevalence rate of
4.4% (National Center for Health Statistics)
Italy
- there are 1,000,000 new cases per year
(2% of the population)
- every year 35,000 operations are carried out to
treat
haemorrhoidal diseases
Classification of internal hemorrhoids
• 1st grade : venous ectasies which bleed, but do not prolapse
• 2nd grade: haemorrhoidal prolapse during defecation, spontaneously reductable
• 3rd grade: haemorrhoidal prolapse during defecation, reductable only manually
• 4th grade: permanent external haemorrhoidal prolapse, non reductable
Goligher, 1975
Option therapy
medical topical medication
orally administered medication
surgical
Milligan-Morgan haemorrhoidectomy
Ferguson haemorrhoidectomy
haemorrhoidopexy using a stapler
Transanal Haemorrhoidal Dearterization (THD)
rubber band ligation
diathermal coagulation
sclerotherapy
outpatient care
Mean volume per knot:
•0.93 ml (first session)
•0.5 ml (others sessions)
abandoned for the high
number of relapses
2nd European Consensus Meeting on Foam Sclerotherapy -Tegernsee, Germany
F. X. Breu et al., Supplement 71, February 2008, 3 VASA 2008; S/71: 3–29
Monitoring of the vital functions using an oxypulsemeter
Technique
Patient in left lateral position
• Rectal exploration
• Introduction of the endoscope into the rectum
• “retroversion” (or inversion) manoeuvre
• Visualization of the hemorrhoidal plexus origin
• puncure into the haemorroid with a 25g needle
Injecting the 3% Polidocanol foam, prepared in according to Tessari
method:
- two luer-lock syringes (10 and 5 cc)
- 3-way cock
- gas (air)/liquid 4:1
- 20 passages using 2 syringes alternatively.
max 3 cc. foam / each globe
max 8 cc foam /session
new session after 3 weeks
usually at least 3 sessions
Protocol
EndoTHeFEndovascular Treatment of Hemorrhoids with Foam
Average duration
8 minutes (range 5-12).
Direct injection
Direct injection of hemorrhoids
CasesJanuary 2009 – June 2013
290 patients rectal bleeding
No. %
males 122 58,1
females 88 41,9
80 exluded for other causes of bleeding
210 enrolled
No. %
1st grade 5 2.5
2nd grade 108 51.4
3rd grade 86 40.9
4th grade 11 5.2
12 patients, already operated on:
6 - Longo
5 - Milligan-Morgan
1 - double Millogan-Morgan + Longo.
32 patients (12,7%)
severe hypocromic microcytic anaemia
( Hgb < 8 g/dL, MCV < 70)
Characteristics of the patients according to the Goligher
classification
Results
765 procedures in 210 patients( means: 3.6 sessions per patient)
Follow-up
12 cases (4,8%) : more than five sessions due to persistant bleeding
2 cases: patients opted for surgical haemorrhoidectomy.
32 patients suffering from severe anaemia
- 3 transfusion of two units of autologous blood
- 29 normalization of haematocrit within 30 days after the 1st treatment
Disappearance of rectal bleeding in
83% of the cases
after the first session
176 patients available
(means: 12 months)
4 patients (1.6 %): local itching
6 patients (1.8 %): local heaviness for a week after
treatment
Adverse effect
No major complications
No major side-effects
Score
4 3 2 1
Bleeding > 1 episode/week < 1 episode/week <1 episode/month never
VAS* 10-8 7-5 4-2 1-0
Discomfort alwais > 7 days/month < 7 days/month <3 days/month
Information obtained insufficient sufficient exhaustive
reasons for recommending the method
Before the first procedure
Before the first procedure and after the last procedure
Questionnaire
After the last procedure
*VAS : visual analogue scale for pain
insufficient sufficient exhaustive
Information obtained - 2.4% 97.6%
Answers to the questionnaire
Reason for recommending the method
Stop the bleeding 98.8%
Absence of pain 98.3%
Get back to usual activities within a day 94.7%
Answers to the questionnaire
proctorragy VAS discomfort
P< 0,0015
Conclusions
• simple, feasable and safe procedure
• painless procedure
• good control of symptoms
Foam endoscopic sclerotherapy:
Recurrence rate
Prospective, randomized, multicentric study needed
?
2. What’s the recurrence rate of hemorrhoids after
hemorroidectomy?
1. Wich are complications after
hemorroidectomy?
Open questions
1. Wich are complications after hemorroidectomy?
2. What’s the recurrence rate of hemorrhoids
after hemorroidectomy?
Open questions
To cure or to operate hemorrhoids…
… that is the question