Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

Medtronic

Status and phase: Completed; Phase 4

Conditions: Fertility Disorders; Uterine Fibroids

Treatments: Other: Ringer lactate solution; Device: Prevadh film

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01388907

CLI 9821-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: Female

Ages: 20 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 2 patient groups

Prevadh film

Experimental group

Description:

Patient randomized in this arm have been treated with Prevadh film applied on the uterine surgical sites, at the end of the myomectomy surgery to prevent post-surgey adhesion formation.

Treatment:

Device: Prevadh film

Ringer solution

Active Comparator group

Description:

Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.

Treatment:

Other: Ringer lactate solution