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Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

Primary Purpose

Uterine Fibroids, Fertility Disorders

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Ringer lactate solution
Prevadh film
Sponsored by
Medtronic - MITG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring myomectomy, adhesion prevention, pregnancy rate

Eligibility Criteria

20 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital
  • Clinique du Tondu
  • Béclère Hospital (Public Assistance of Paris Hospital)
  • UNIVERSITY HOSPITAL Estaing
  • University Carémeau Hospital
  • TENON Hospital (Public Assistance of Paris Hospital)
  • TROUSSEAU Hospital (Public Assistance of Paris Hospital)
  • Bichat Hospital - Claude Bernard (Public Assistance of Paris Hospital)
  • South University Hospital
  • Centre Hospitalier des quatre villes
  • Versailles Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prevadh film

Ringer solution

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Fertility
Fertility was assessed by pregnancy and deliveries rates at 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).
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).

Full Information

First Posted
July 5, 2011
Last Updated
November 16, 2016
Sponsor
Medtronic - MITG
Collaborators
Registrat-Mapi
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1. Study Identification

Unique Protocol Identification Number
NCT01388907
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic - MITG
Collaborators
Registrat-Mapi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids, Fertility Disorders
Keywords
myomectomy, adhesion prevention, pregnancy rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prevadh film
Arm Type
Experimental
Arm Description
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.
Arm Title
Ringer solution
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Ringer lactate solution
Other Intervention Name(s)
Myomectomy by Laparotomy
Intervention Description
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
Device
Intervention Name(s)
Prevadh film
Other Intervention Name(s)
Myomectomy by Laparotomy
Intervention Description
Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.
Primary Outcome Measure Information:
Title
Number of Patients With Adhesions to Uterine Scars
Description
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.
Time Frame
10 to 20 weeks post surgery
Secondary Outcome Measure Information:
Title
Fertility
Description
Fertility was assessed by pregnancy and deliveries rates at 3 years.
Time Frame
3 years
Title
Adnexal Adhesions
Description
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).
Time Frame
10 to 20 weeks post surgery
Title
mAFS Abdominopelvic Adhesion Score
Description
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).
Time Frame
10 to 20 weeks post surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BECKER Patrice
Organizational Affiliation
Sofradim Production
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
CANIS Michel, Pr
Organizational Affiliation
University Hospital Estaing - 63003 CLERMONT-FERRAND Cedex
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Clinique du Tondu
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Béclère Hospital (Public Assistance of Paris Hospital)
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
UNIVERSITY HOSPITAL Estaing
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
University Carémeau Hospital
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
TENON Hospital (Public Assistance of Paris Hospital)
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
TROUSSEAU Hospital (Public Assistance of Paris Hospital)
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Bichat Hospital - Claude Bernard (Public Assistance of Paris Hospital)
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
South University Hospital
City
Rennes
ZIP/Postal Code
35023
Country
France
Facility Name
Centre Hospitalier des quatre villes
City
Sevres
ZIP/Postal Code
92317
Country
France
Facility Name
Versailles Hospital
City
Versailles
ZIP/Postal Code
78157
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24841647
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.
Results Reference
derived

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Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

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