Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

Uterine Fibroids Clinical Trial

Official title:

Efficacy and Safety of Prevadh™ in the Prevention of Adhesions in Gynaecological Surgery: a Multicenter, Randomized, French Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01388907
• Other study ID #: CLI 9821-2
• Status: Completed
• Phase: Phase 4
• First received: July 5, 2011
• Last updated: November 16, 2016
• Start date: May 2006
• Est. completion date: June 2011

Study information

• Verified date: November 2016
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2011
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fertility Disorders
• Leiomyoma
• Tissue Adhesions
• Uterine Fibroids

Intervention

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.

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.

Locations

Country	Name	City	State
France	University Hospital	Angers
France	Clinique du Tondu	Bordeaux
France	Béclère Hospital (Public Assistance of Paris Hospital)	Clamart
France	UNIVERSITY HOSPITAL Estaing	Clermont-ferrand
France	University Carémeau Hospital	Nimes
France	Bichat Hospital - Claude Bernard (Public Assistance of Paris Hospital)	Paris
France	TENON Hospital (Public Assistance of Paris Hospital)	Paris
France	TROUSSEAU Hospital (Public Assistance of Paris Hospital)	Paris
France	South University Hospital	Rennes
France	Centre Hospitalier des quatre villes	Sevres
France	Versailles Hospital	Versailles

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic - MITG	Registrat-Mapi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Fertility	Fertility was assessed by pregnancy and deliveries rates at 3 years.	3 years	Yes
Secondary	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	No
Secondary	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	No