Clinical trial · Interventional
Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy
Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy by the Abdominal Route: Prospective,Randomized, Multicenter and Pilot Study.
NCT04702399CI-TRIAL-00049324PREVENDOunknownN/AClinicalTrials.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)
PREVENDO is a prospective, multicenter, pilot, and randomized study in 2 parallel arms and single blind, evaluating the proportion of endometrial synechiae 6 weeks after surgery in patients undergoing abdominal myomectomy or polymyomectomy, according to the application or not of an anti-adhesion gel (HYALOBARRIER® GEL ENDO)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patients With an Indication for Myomectomy or Polymyomectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GEL GROUP | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GEL GROUP
- description
- Intracavitary application of an anti-adhesion hyaluronic acid gel (HYALOBARRIER® GEL ENDO)
- interventionNames
- Device: GEL GROUP
- type
- NO_INTERVENTION
- label
- CONTROL GROUP
- description
- No Intervention
Primary outcomes (1)
- measure
- The proportion of patients with endometrial synechiae
- timeFrame
- 6 weeks after surgery (+/-2weeks)
- description
- The evaluation of the proportion of endometrial synechiae in patients udergoing abdominal myomectomy or polymyoomectomy, during diagnostic hysteroscopy performed 6 weeks after surgery.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 2. Of childbearing age 3. Indication of myomectomy / polymyomectomy by laparotomy / laparoscopy / robot-assisted laparoscopy 4. FIGO 2 to 6 classification myomas Exclusion Criteria: 1. History of intra uterine synechia treatment 2. Uterine malformation 3. Patients under legal protection measure (guardianship or curatorship) or under security measure 4. Pregnant or breastfeeding women 5. Absence of health insurance; or patient with AME 6. Absence of free, informed and written consent 7. Endometrial synechia before operation (grade 1-3) (assessed by systematic diagnostic hysteroscopy) 8. Patient with upper genital infection 9. Hypersensibility to hyaluronic acid
References
Publications (0)
Data not yet available
No reference posted for this study.