Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

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.

Inclusion Criteria:

• Symptomatic(s) or asymptomatic(s) uterin(s) fibroma(s) being able to interfere with the fertility by the patient who having an immediate or differed desire of pregnancy.
• Size: diameter ≥ 6 cm at echographia (for the highest diameter)
• Location interstitial and / or subserosa
• planned laparotomic surgery
• negative pregnancy test within 48 hours of surgery
• signed inform consent

Exclusion Criteria:

• History of abdomino-pelvic surgery (except appendicectomy - cesarotomy)
• Pre-operative embolization
• Endometriosis stage >1 (American Fertility Society classification ≥ 5)
• Pregnant patient
• Diabetes
• Chronic corticotherapy / immuno-supressor or immuno-modulator drugs
• Previous analog LH-RH drug therapy for the uterine myoma