Clinical trial NCT01388907: Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery
Official title: Efficacy and Safety of Prevadh™ in the Prevention of Adhesions in Gynaecological Surgery: a Multicenter, Randomized, French Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Uterine Fibroids
Fertility Disorders
Keywords: myomectomy
adhesion prevention
pregnancy rate
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
Collaborators: name: Registrat-Mapi
First posted: 2011-07-07
Enrollment: 61
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Adhesions to Uterine Scars
timeFrame: 10 to 20 weeks post surgery
Secondary outcomes:
measure: Fertility
timeFrame: 3 years
measure: Adnexal Adhesions
timeFrame: 10 to 20 weeks post surgery
measure: mAFS Abdominopelvic Adhesion Score
timeFrame: 10 to 20 weeks post surgery
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
city: Bordeaux
country: France
facility: Clinique du Tondu
city: Clamart
country: France
facility: Béclère Hospital (Public Assistance of Paris Hospital)
city: Clermont-ferrand
country: France
facility: UNIVERSITY HOSPITAL Estaing
city: Nimes
country: France
facility: University Carémeau Hospital
city: Paris
country: France
facility: TENON Hospital (Public Assistance of Paris Hospital)
city: Paris
country: France
facility: TROUSSEAU Hospital (Public Assistance of Paris Hospital)
city: Paris
country: France
facility: Bichat Hospital - Claude Bernard (Public Assistance of Paris Hospital)
city: Rennes
country: France
facility: South University Hospital
city: Sevres
country: France
facility: Centre Hospitalier des quatre villes
city: Versailles
country: France
facility: Versailles Hospital
Study officials:
affiliation: Sofradim Production
name: BECKER Patrice
role: STUDY_DIRECTOR
affiliation: University Hospital Estaing - 63003 CLERMONT-FERRAND Cedex
name: CANIS Michel, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.