Clinical trial · Interventional
ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
ABSOLUTELY: A Multicenter Randomized Controlled Trial of Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
NCT04519593CI-TRIAL-00052697unknownN/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)
A phase 3 multicenter unblinded randomized controlled trial comparing the temporary uterine blood supply occlusion with conventional approach during laparoscopic myomectomy in patients with uterine leiomyoma.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blood Loss, Surgical | — | UNRESOLVED | — |
| Fertility Issues | — | UNRESOLVED | — |
| Laparoscopic Myomectomy | — | UNRESOLVED | — |
| Leiomyoma, Uterine | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Myoma;Uterus | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
| Pregnancy Complications | — | UNRESOLVED | — |
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Uterine Leiomyoma | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional laparoscopic myomectomy | Procedure | — | UNRESOLVED |
| Laparoscopic myomectomy with prior temporary uterine blood supply occlusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laparoscopic myomectomy with temporary blood supply occlusion
- description
- Laparoscopic myomectomy is performed with prior visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries.
- interventionNames
- Procedure: Laparoscopic myomectomy with prior temporary uterine blood supply occlusion
- type
- ACTIVE_COMPARATOR
- label
- Conventional laparoscopic myomectomy
- description
- Laparoscopic myomectomy is performed without prior temporary blood supply occlusion.
- interventionNames
- Procedure: Conventional laparoscopic myomectomy
Primary outcomes (1)
- measure
- Blood loss
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Symptomatic uterine leiomyoma * Size of leiomyoma node \>5 cm based on imaging * Leiomyoma node types 3, 4, 5, 6 according to The International Federation of Gynecology and Obstetrics (FIGO) classification or type 2 not feasible to be removed during hysteroscopy * Single or multiple nodes * Absent contraindications for laparoscopic myomectomy * Voluntarily signed informed consent to participate in the study Exclusion Criteria: * Age \< 18 years * Asymptomatic uterine leiomyoma * Size of leiomyoma node \<5 cm based on imaging * Absence of leiomyoma node types 3, 4, 5, 6 according to FIGO classification and type 2 not feasible to be removed during hysteroscopy * Planned simultaneous hysteroscopy with leiomyoma node excision * Current pregnancy and breastfeeding * Suspicion of a malignant uterine tumor * Prior uterine leiomyoma surgery * Contraindications for laparoscopic myomectomy * Lack of decision-making capacity hindering signing the consent to participate in the study
References
Publications (0)
Data not yet available
No reference posted for this study.