Clinical trial · Interventional
Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
NCT05683041CI-TRIAL-00122905PALLMrecruitingN/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)
Clinical study on the prevention of intrauterine adhesions after laparoscopic or laparotomic myomectomy. Myomas are common in women of reproductive age and myomectomy can lead to intra-uterine adhesions, which can be detrimental to fertility. This study investigates whether the use of an intrauterine gel can prevent the development of these adhesions.
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 |
|---|---|---|---|
| Myoma | Myoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyalobarrier | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- intrauterine gel application
- description
- Application of Hyalobarrier intrauterine after myomectomy.
- interventionNames
- Device: Hyalobarrier
- type
- NO_INTERVENTION
- label
- no intra-uterine gel application
- description
- No application of Halobarrier intrauterine after myomectomy.
Primary outcomes (1)
- measure
- Adhesion formation postoperatief.
- timeFrame
- 3 months post surgery
- description
- The presence of intra-uterine adhesions on a second look hysteroscopy.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * age between 18 and 45 years. * intramurale and/or subserosal myoma (FIGO 3-6), and/or hybrid myoma (with a connection to the endometrium and serosa (FIGO 2-5), who are scheduled for laparoscopic / laparotomic myomectomy. * absence of intra-uterine adhesions on preoperative diagnostic hysteroscopy Exclusion Criteria: * pregnancy. * laparoscopic or laparotomic myomectomy in combination with an operative hysteroscopy. * presence of endometritis. * other antiadhesion methods
References
Publications (0)
Data not yet available
No reference posted for this study.