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Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

NCT ID: NCT01388907

Last Updated: 2016-11-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Uterine Fibroids Fertility Disorders

Keywords

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myomectomy adhesion prevention pregnancy rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Prevadh film

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Ringer lactate solution

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type DEVICE

Other Intervention Names

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Myomectomy by Laparotomy Myomectomy by Laparotomy

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Registrat-Mapi

OTHER

Sponsor Role collaborator

Medtronic - MITG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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BECKER Patrice

Role: STUDY_DIRECTOR

Sofradim Production

CANIS Michel, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital Estaing - 63003 CLERMONT-FERRAND Cedex

Locations

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University Hospital

Angers, , France

Site Status

Clinique du Tondu

Bordeaux, , France

Site Status

Béclère Hospital (Public Assistance of Paris Hospital)

Clamart, , France

Site Status

UNIVERSITY HOSPITAL Estaing

Clermont-Ferrand, , France

Site Status

University Carémeau Hospital

Nîmes, , France

Site Status

TENON Hospital (Public Assistance of Paris Hospital)

Paris, , France

Site Status

TROUSSEAU Hospital (Public Assistance of Paris Hospital)

Paris, , France

Site Status

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

Paris, , France

Site Status

South University Hospital

Rennes, , France

Site Status

Centre Hospitalier des quatre villes

Sèvres, , France

Site Status

Versailles Hospital

Versailles, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 24841647 (View on PubMed)

Other Identifiers

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CLI 9821-2

Identifier Type: -

Identifier Source: org_study_id