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Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01388907
First Posted: July 7, 2011
Last Update Posted: November 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Registrat-Mapi
Information provided by (Responsible Party):
Medtronic - MITG
  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
Intervention Model: Parallel Assignment
Masking: Single (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 ]

    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 ]
    Fertility was assessed by pregnancy and deliveries rates at 3 years.

  • Adnexal Adhesions [ Time Frame: 10 to 20 weeks post surgery ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 42 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: July 5, 2011
First Posted: July 7, 2011
Results First Submitted: June 21, 2013
Results First Posted: November 17, 2016
Last Update Posted: November 17, 2016
Last Verified: November 2016

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

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