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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01388907
Study type Interventional
Source Medtronic - MITG
Contact
Status Completed
Phase Phase 4
Start date May 2006
Completion date June 2011

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