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Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

This study has been completed.
Sponsor:
Collaborator:
Registrat-Mapi
Information provided by (Responsible Party):
Medtronic - MITG
ClinicalTrials.gov Identifier:
NCT01388907
First received: July 5, 2011
Last updated: November 16, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Uterine Fibroids
Fertility Disorders
Other: Ringer lactate solution
Device: Prevadh film
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Prevadh™ in the Prevention of Adhesions in Gynaecological Surgery: a Multicenter, Randomized, French Study

Resource links provided by NLM:


Further study details as provided by Medtronic - MITG:

Primary Outcome Measures:
  • Number of Patients With Adhesions to Uterine Scars [ Time Frame: 10 to 20 weeks post surgery ] [ Designated as safety issue: No ]

    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 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Fertility was assessed by pregnancy and deliveries rates at 3 years.

  • Adnexal Adhesions [ Time Frame: 10 to 20 weeks post surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 to 20 weeks post surgery ] [ Designated as safety issue: No ]
    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).


Enrollment: 61
Study Start Date: May 2006
Study Completion Date: June 2011
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Name: Myomectomy by Laparotomy
Active Comparator: 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.
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.
Other Name: Myomectomy by Laparotomy

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

Ages Eligible for Study:   20 Years to 42 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388907

Locations
France
University Hospital
Angers, France, 49933
Clinique du Tondu
Bordeaux, France, 33000
Béclère Hospital (Public Assistance of Paris Hospital)
Clamart, France, 92141
UNIVERSITY HOSPITAL Estaing
Clermont-ferrand, France, 63003
University Carémeau Hospital
Nimes, France, 30029
TENON Hospital (Public Assistance of Paris Hospital)
Paris, France, 75020
TROUSSEAU Hospital (Public Assistance of Paris Hospital)
Paris, France, 75571
Bichat Hospital - Claude Bernard (Public Assistance of Paris Hospital)
Paris, France, 75877
South University Hospital
Rennes, France, 35023
Centre Hospitalier des quatre villes
Sevres, France, 92317
Versailles Hospital
Versailles, France, 78157
Sponsors and Collaborators
Medtronic - MITG
Registrat-Mapi
Investigators
Study Director: BECKER Patrice Sofradim Production
Principal Investigator: CANIS Michel, Pr University Hospital Estaing - 63003 CLERMONT-FERRAND Cedex
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01388907     History of Changes
Other Study ID Numbers: CLI 9821-2 
Study First Received: July 5, 2011
Results First Received: June 21, 2013
Last Updated: November 16, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Medtronic - MITG:
myomectomy
adhesion prevention
pregnancy rate

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Tissue Adhesions
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on December 02, 2016