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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
61
Ringer lactate solution was applied directly onto the uterine surgical sites at the end of the myomectomy surgery, to prevent post-surgical adhesion formation.
Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.
University Hospital
Angers, France
Clinique du Tondu
Bordeaux, France
Béclère Hospital (Public Assistance of Paris Hospital)
Clamart, France
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.
Time frame: 10 to 20 weeks post surgery
Fertility
Fertility was assessed by pregnancy and deliveries rates at 3 years.
Time frame: 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).
Time frame: 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).
Time frame: 10 to 20 weeks post surgery
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UNIVERSITY HOSPITAL Estaing
Clermont-Ferrand, France
University Carémeau Hospital
Nîmes, France
TENON Hospital (Public Assistance of Paris Hospital)
Paris, France
TROUSSEAU Hospital (Public Assistance of Paris Hospital)
Paris, France
Bichat Hospital - Claude Bernard (Public Assistance of Paris Hospital)
Paris, France
South University Hospital
Rennes, France
Centre Hospitalier des quatre villes
Sèvres, France
...and 1 more locations