Phase 4
Completed N=61
Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery
Uterine Fibroids · Fertility Disorders
Source: ClinicalTrials.gov NCT01388907 ↗
Enrolled (actual)
61
Serious AEs
18.0%
Results posted
Nov 2016
Primary outcomePrimary: Number of Patients With Adhesions to Uterine Scars — 12; 24 participants
◆ Published Evidence
Established
26citations · ~2 / year
Adhesion prevention after myomectomy by laparotomy: a prospective multicenter comparative randomized single-blind study with second-look laparoscopy to assess the effectiveness of PREVADH™.
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.
Linked Publications
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Adhesion prevention after myomectomy by laparotomy: a prospective multicenter comparative randomized single-blind study with second-look laparoscopy to assess the effectiveness of PREVADH™.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.