Phase 4
N=61
Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery
Uterine Fibroids · Fertility Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01388907 ↗Enrolled (actual)
61
Serious AEs
18.0%
Results posted
Nov 2016
Primary outcome: Primary: Number of Patients With Adhesions to Uterine Scars — 12; 24 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ringer lactate solution (Other); Prevadh film (Device)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Medtronic - MITG
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adhesions to Uterine Scars |
12; 24 | — |
| SECONDARY Fertility |
14; 4; 11; 3 | — |
| SECONDARY Adnexal Adhesions |
4.0; 6.3 | — |
| SECONDARY mAFS Abdominopelvic Adhesion Score |
1.6; 2.4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01388907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.