Uterine Fibroids Clinical Trial
Official title:
Efficacy and Safety of Prevadh™ in the Prevention of Adhesions in Gynaecological Surgery: a Multicenter, Randomized, French Study
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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