Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Prevadh™ in the Prevention of Adhesions in Gynaecological Surgery: a Multicenter, Randomized, French Study

Conditions
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Uterine Fibroids, Fertility Disorders

Intervention / Treatment
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* Other: Ringer lactate solution
* Device: Prevadh film


Participation Criteria
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Eligibility Criteria
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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: History of abdomino-pelvic surgery (except appendicectomy - cesarotomy) Pre-operative embolization Endometriosis stage >1 (American Fertility Society classification ≥ 5) Pregnant patient Diabetes Chronic corticotherapy / immuno-supressor or immuno-modulator drugs Previous analog LH-RH drug therapy for the uterine myoma

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevadh film<br>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. | Device: Prevadh film<br>* Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.<br>* Other names: Myomectomy by Laparotomy;|
| Active Comparator: Ringer solution<br>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. | Other: Ringer lactate solution<br>* Ringer lactate solution was applied directly onto the uterine surgical sites at the end of the myomectomy surgery, to prevent post-surgical adhesion formation.<br>* Other names: Myomectomy by Laparotomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Adhesions to Uterine Scars | 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. | 10 to 20 weeks post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertility | Fertility was assessed by pregnancy and deliveries rates at 3 years. | 3 years | 
| Adnexal Adhesions | 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). | 10 to 20 weeks post surgery | 
| mAFS Abdominopelvic Adhesion Score | 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). | 10 to 20 weeks post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myomectomy, adhesion prevention, pregnancy rate