Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

NCT01388907 | Completed Phase 4 Results

• 1 other identifier: CLI 9821-2
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 11

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.

Conditions

Uterine Fibroids; Fertility Disorders

Keywords

myomectomy; adhesion prevention; pregnancy rate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Fertility

  3 years

• Adnexal Adhesions

  10 to 20 weeks post surgery

• mAFS Abdominopelvic Adhesion Score

  10 to 20 weeks post surgery

Study Arms (2)

Prevadh film

EXPERIMENTAL

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

Ringer solution

ACTIVE COMPARATOR

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

Interventions

Ringer lactate solution OTHER

Ringer lactate solution was applied directly onto the uterine surgical sites at the end of the myomectomy surgery, to prevent post-surgical adhesion formation.

Also known as: Myomectomy by Laparotomy

Ringer solution

Prevadh film DEVICE

Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.

Also known as: Myomectomy by Laparotomy

Prevadh film

Eligibility Criteria

• Age: 20 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic - MITG: lead
• Registrat-Mapi: collaborator

Study Sites (11)

University Hospital

Angers, 49933, France

Location

Clinique du Tondu

Bordeaux, 33000, France

Location

Béclère Hospital (Public Assistance of Paris Hospital)

Clamart, 92141, France

Location

UNIVERSITY HOSPITAL Estaing

Clermont-Ferrand, 63003, France

Location

University Carémeau Hospital

Nîmes, 30029, France

Location

TENON Hospital (Public Assistance of Paris Hospital)

Paris, 75020, France

Location

TROUSSEAU Hospital (Public Assistance of Paris Hospital)

Paris, 75571, France

Location

Bichat Hospital - Claude Bernard (Public Assistance of Paris Hospital)

Paris, 75877, France

Location

South University Hospital

Rennes, 35023, France

Location

Centre Hospitalier des quatre villes

Sèvres, 92317, France

Location

Versailles Hospital

Versailles, 78157, France

Location

Related Publications (1)

• 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.

  PMID: 24841647 DERIVED

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Limitations and Caveats

the surgeons were not blinded to the patients' allocation group at second-look laparoscopy.Recruitment was stopped early. 2 data analyses have been performed over the study period for primary endpoint, without any error type I adjustment.

Results Point of Contact

• Title: Patrice BECKER, Global Director, Clinical Affairs
• Organization: Sofradim Production COVIDIEN

patrice.becker@covidien.com

+33 4 74 08 92 38

Study Officials

• BECKER Patrice

  Sofradim Production

  STUDY DIRECTOR

• CANIS Michel, Pr

  University Hospital Estaing - 63003 CLERMONT-FERRAND Cedex

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 7, 2011
• Study Start: May 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2011
• Last Updated: November 17, 2016
• Results First Posted: November 17, 2016

Record last verified: 2016-11

Locations

FR (11)