Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery
|Uterine Fibroids Fertility Disorders||Other: Ringer lactate solution Device: Prevadh film||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Prevadh™ in the Prevention of Adhesions in Gynaecological Surgery: a Multicenter, Randomized, French Study|
- Number of Patients With Adhesions to Uterine Scars [ Time Frame: 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.
- Fertility [ Time Frame: 3 years ]Fertility was assessed by pregnancy and deliveries rates at 3 years.
- Adnexal Adhesions [ Time Frame: 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).
- mAFS Abdominopelvic Adhesion Score [ Time Frame: 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).
|Study Start Date:||May 2006|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Experimental: 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.
Device: Prevadh film
Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.
Other Name: Myomectomy by Laparotomy
Active Comparator: Ringer 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.
Other: Ringer lactate solution
Ringer lactate solution was applied directly onto the uterine surgical sites at the end of the myomectomy surgery, to prevent post-surgical adhesion formation.
Other Name: Myomectomy by Laparotomy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388907
|Angers, France, 49933|
|Clinique du Tondu|
|Bordeaux, France, 33000|
|Béclère Hospital (Public Assistance of Paris Hospital)|
|Clamart, France, 92141|
|UNIVERSITY HOSPITAL Estaing|
|Clermont-ferrand, France, 63003|
|University Carémeau Hospital|
|Nimes, France, 30029|
|TENON Hospital (Public Assistance of Paris Hospital)|
|Paris, France, 75020|
|TROUSSEAU Hospital (Public Assistance of Paris Hospital)|
|Paris, France, 75571|
|Bichat Hospital - Claude Bernard (Public Assistance of Paris Hospital)|
|Paris, France, 75877|
|South University Hospital|
|Rennes, France, 35023|
|Centre Hospitalier des quatre villes|
|Sevres, France, 92317|
|Versailles, France, 78157|
|Study Director:||BECKER Patrice||Sofradim Production|
|Principal Investigator:||CANIS Michel, Pr||University Hospital Estaing - 63003 CLERMONT-FERRAND Cedex|