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Completed

NCT Number: NCT01388907

Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

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.

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Key information

Conditions

Uterine Fibroids Fertility Disorders Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

20 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ringer lactate solution

Other

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 names: Myomectomy by Laparotomy

Prevadh film

Device

Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.

Other names: Myomectomy by Laparotomy

Primary outcomes

  1. 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 outcomes

  1. Fertility

    Time frame: 3 years

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

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Collaborators

  • Registrat-Mapi

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2011
First posted
Jul 7, 2011
Registry last updated
Nov 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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