Clinical trial · Interventional
Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery
Efficacy and Safety of Prevadh™ in the Prevention of Adhesions in Gynaecological Surgery: a Multicenter, Randomized, French Study
NCT01388907CI-TRIAL-00024819completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fertility Disorders | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prevadh film | Device | — | UNRESOLVED |
| Ringer lactate solution | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prevadh film
- description
- 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.
- interventionNames
- Device: Prevadh film
- type
- ACTIVE_COMPARATOR
- label
- Ringer solution
- description
- 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.
- interventionNames
- Other: Ringer lactate solution
Primary outcomes (1)
- measure
- Number of Patients With Adhesions to Uterine Scars
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 42 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCanis MJ, Triopon G, Darai E, Madelenat P, LeVeque J, Panel P, Fernandez H, Audebert A, Descamps P, Castaing N, Roman H, Fauconnier A, Benifla JL. Adhesion prevention after myomectomy by laparotomy: a prospective multicenter comparative randomized single-blind study with second-look laparoscopy to assess the effectiveness of PREVADH. Eur J Obstet Gynecol Reprod Biol. 2014 Jul;178:42-7. doi: 10.1016/j.ejogrb.2014.03.020. Epub 2014 Apr 8. PMID 24841647