Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery Prospective Multicentre Randomized Comparative Study
20 Years
42 Years
Female
Uterine Fibroids, Fertility Disorders
Trial Information
Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery Prospective Multicentre Randomized Comparative 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Adhesion rate
Outcome Description:
Assessment of adhesion rate to the uterine surgical sites during a laparoscopic second look
Outcome Time Frame:
10 to 20 weeks post surgery
Safety Issue:
No
Principal Investigator
BECKER Patrice
Investigator Role:
Study Director
Investigator Affiliation:
Sofradim Production
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
CLI 9821-2
NCT ID:
NCT01388907
Start Date:
May 2006
Completion Date:
June 2011
Related Keywords:
- Uterine Fibroids
- Fertility Disorders
- myomectomy
- adhesion prevention
- pregnancy rate
- Tissue Adhesions
- Leiomyoma
- Myofibroma
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