Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

Phase 4

Completed

Brief Summary: The purpose of this study was to evaluate clinically the efficacy of the PREVADH® Film in the prevention of adhesions in gynaecologic surgery, and to assess post-operative complications related to adhesions and pregnancy rate after myomectomy by open surgery.

Detailed Description: This study was addressed to patients having an immediate or differed pregnancy desire and presenting a symptomatic or asymptomatic fibroma being able to interfere with fertility.

* The primary end point was the assessment of adhesion rate to the uterine surgical sites during a laparoscopic second look performed 10 to 20 weeks post-surgery.

* The secondary end points were the assessment, throughout a 3 years follow-up period, of:

* pregnancy rate,

* adverse events related to adhesions,

* adnexal adhesions according to American Fertility Society score,

* abdomino-pelvic adhesions according to the modified American Fertility Society score.

Recruitment & Eligibility

Inclusion Criteria

Symptomatic(s) or asymptomatic(s) uterin(s) fibroma(s) being able to interfere with the fertility by the patient who having an immediate or differed desire of pregnancy.
Size: diameter ≥ 6 cm at echographia (for the highest diameter)
Location interstitial and / or subserosa
planned laparotomic surgery
negative pregnancy test within 48 hours of surgery
signed inform consent

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Ringer solution	Ringer lactate solution	Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
Prevadh film	Prevadh film	Patient randomized in this arm have been treated with Prevadh film applied on the uterine surgical sites, at the end of the myomectomy surgery to prevent post-surgey adhesion formation.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Adhesions to Uterine Scars	10 to 20 weeks post surgery	The primary endpoint was the assessment of adhesions to uterine scars and comprised the incidence (expressed per patient and per uterine scar), extent, and severity of adhesions observed during the second-look laparoscopy performed 10 to 20 weeks after the myomectomy. This assessment was made by the surgeon (investigator) on the one hand and by two independent surgeons who reviewed the video recordings on the other hand.

Secondary Outcome Measures

Name	Time	Method
Fertility	3 years	Fertility was assessed by pregnancy and deliveries rates at 3 years.
mAFS Abdominopelvic Adhesion Score	10 to 20 weeks post surgery	mAFS abdominopelvic adhesion score in 23 sites (at the anterior caudal peritoneum; parietocolic gutter right; right and left colon; right and left anterior cranial peritoneum; rectosigmoid; omentum; small intestine; anterior and posterior uterus; posterior cul-de-sac; right and left ovaries \[internal and lateral sides\], pelvic side walls, ovarian fossae, tubes, and bulbs). It ranges from 0 (best possible outcome) to 16 (worse possible outcome).
Adnexal Adhesions	10 to 20 weeks post surgery	Adnexal Adhesions were assessed by AFS score. AFS (= American Fertility Society) score was developed in 1980's by the American Fertility Society in an effort to address needs for a classification scheme for adnexal adhesions suspected to be associated with infertility. 4 anatomic sites evaluated: R-tube; R-ovary; L-tube; L-ovary. Final AFS score for a patient is the score of the side with lower summed score. The higher score, representing the side with the higher adhesion burden, is dropped; Score AFS is from 0 (best possible outcome) to 32 (worse possible outcome).

Locations (11): University Hospital
🇫🇷
Angers, France
UNIVERSITY HOSPITAL Estaing
🇫🇷
Clermont-ferrand, France
University Carémeau Hospital
🇫🇷
Nimes, France
Clinique du Tondu
🇫🇷
Bordeaux, France
Centre Hospitalier des quatre villes
🇫🇷
Sevres, France
Versailles Hospital
🇫🇷
Versailles, France
South University Hospital
🇫🇷
Rennes, France
Bichat Hospital - Claude Bernard (Public Assistance of Paris Hospital)
🇫🇷
Paris, France
TROUSSEAU Hospital (Public Assistance of Paris Hospital)
🇫🇷
Paris, France
Béclère Hospital (Public Assistance of Paris Hospital)
🇫🇷
Clamart, France
TENON Hospital (Public Assistance of Paris Hospital)
🇫🇷
Paris, France