Spots Global Cancer Trial Database for Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

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

Study ID: NCT01388907

Conditions

Uterine Fibroids

Fertility Disorders

Interventions

Ringer lactate solution

Prevadh film

Study Description

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.