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.

Study Overview

• Status: Completed
• Conditions: Fertility Disorders; Uterine Fibroids
• Intervention / Treatment: Device: Prevadh film; Other: Ringer lactate solution

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • University Hospital
  • Bordeaux, France, 33000
    • Clinique du Tondu
  • Clamart, France, 92141
    • Béclère Hospital (Public Assistance of Paris Hospital)
  • Clermont-ferrand, France, 63003
    • UNIVERSITY HOSPITAL Estaing
  • Nimes, France, 30029
    • University Carémeau Hospital
  • Paris, France, 75020
    • TENON Hospital (Public Assistance of Paris Hospital)
  • Paris, France, 75571
    • TROUSSEAU Hospital (Public Assistance of Paris Hospital)
  • Paris, France, 75877
    • Bichat Hospital - Claude Bernard (Public Assistance of Paris Hospital)
  • Rennes, France, 35023
    • South University Hospital
  • Sevres, France, 92317
    • Centre Hospitalier des quatre villes
  • Versailles, France, 78157
    • Versailles Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prevadh film; 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.	Device: Prevadh film; Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.; Other Names: Myomectomy by Laparotomy
Active Comparator: Ringer solution; 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.	Other: Ringer lactate solution; Ringer lactate solution was applied directly onto the uterine surgical sites at the end of the myomectomy surgery, to prevent post-surgical adhesion formation.; Other Names: Myomectomy by Laparotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Adhesions to Uterine Scars	The primary endpoint was the assessment of adhesions to uterine scars and comprised the incidence (expressed per patient and per uterine scar), extent, and severity of adhesions observed during the second-look laparoscopy performed 10 to 20 weeks after the myomectomy. This assessment was made by the surgeon (investigator) on the one hand and by two independent surgeons who reviewed the video recordings on the other hand.	10 to 20 weeks post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertility	Fertility was assessed by pregnancy and deliveries rates at 3 years.	3 years
Adnexal Adhesions	Adnexal Adhesions were assessed by AFS score. AFS (= American Fertility Society) score was developed in 1980's by the American Fertility Society in an effort to address needs for a classification scheme for adnexal adhesions suspected to be associated with infertility. 4 anatomic sites evaluated: R-tube; R-ovary; L-tube; L-ovary. Final AFS score for a patient is the score of the side with lower summed score. The higher score, representing the side with the higher adhesion burden, is dropped; Score AFS is from 0 (best possible outcome) to 32 (worse possible outcome).	10 to 20 weeks post surgery
mAFS Abdominopelvic Adhesion Score	mAFS abdominopelvic adhesion score in 23 sites (at the anterior caudal peritoneum; parietocolic gutter right; right and left colon; right and left anterior cranial peritoneum; rectosigmoid; omentum; small intestine; anterior and posterior uterus; posterior cul-de-sac; right and left ovaries [internal and lateral sides], pelvic side walls, ovarian fossae, tubes, and bulbs). It ranges from 0 (best possible outcome) to 16 (worse possible outcome).	10 to 20 weeks post surgery

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Collaborators: Registrat-Mapi
• Investigators: Study Director: BECKER Patrice, Sofradim Production; Principal Investigator: CANIS Michel, Pr, University Hospital Estaing - 63003 CLERMONT-FERRAND Cedex

Publications and helpful links

General Publications

• Canis MJ, Triopon G, Darai E, Madelenat P, LeVeque J, Panel P, Fernandez H, Audebert A, Descamps P, Castaing N, Roman H, Fauconnier A, Benifla JL. Adhesion prevention after myomectomy by laparotomy: a prospective multicenter comparative randomized single-blind study with second-look laparoscopy to assess the effectiveness of PREVADH. Eur J Obstet Gynecol Reprod Biol. 2014 Jul;178:42-7. doi: 10.1016/j.ejogrb.2014.03.020. Epub 2014 Apr 8.

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: July 5, 2011
• First Submitted That Met QC Criteria: July 5, 2011
• First Posted (Estimate): July 7, 2011

Study Record Updates

• Last Update Posted (Estimate): November 17, 2016
• Last Update Submitted That Met QC Criteria: November 16, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: pregnancy rate; myomectomy; adhesion prevention
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Fibrosis; Cicatrix; Neoplasms, Muscle Tissue; Tissue Adhesions; Leiomyoma
• Other Study ID Numbers: CLI 9821-2