Clinical trial · Interventional
Laparoscopic Enclosed Morcellation; Electromechanic Morcellation vs Vaginal Removal
Enclosed Electromechanical Morcellation and Vaginal Removal During Laparoscopic Myomectomy
- 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)
Laparoscopic tissue removal is one of the most challenging parts for the laparoscopic surgery. For this reason, electromechanical morcellation has long been used to facilitate the tissue removal in gynecology. However, electromechanical morcellation has long been performed inside the abdomen without any containment. Therefore, this practice has recently undergone increased scrutiny because of important concerns related to tissue dissemination during intracorporeal power morcellation. Thus, the US Food and Drug Administration released a safety communication discouraging power morcellation in laparoscopic hysterectomy and myomectomy procedures in April 2014. As a result of this serious concern, the enclosed laparoscopic power morcellation has been come into prominence in gynecological surgery. Besides the removal of the tissues through vagina with posterior colpotomy is considered an another solution for this critical problem. In the literature the comparison for the two techniques for tissue removal is considerably scarce. Therefore researchers are aiming to prepare a trial to compare the laparoscopic enclosed electromechanical morcellation and tissue removal thorough vagina with posterior colpotomy according to surgical time, postoperative pain and postoperative sexual function.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enclosed morcellation | Procedure | — | UNRESOLVED |
| vaginal morcellation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- enclosed morcellation
- description
- In this group, after extirpation of the myoma from the uterus and repair of the uterine defect, the myoma will be removed from the abdomen with an enclosed laparoscopic electromechanical morcellation as described in the literature by Akdemir et al with using surgical glove (Akdemir A et. al, Innovative technique for enclosed morcellation using a surgical glove. Obstet Gynecol. 2015 May;125(5):1145-9. doi: 10.1097/AOG.0000000000000823.).
- interventionNames
- Procedure: Enclosed morcellation
- type
- ACTIVE_COMPARATOR
- label
- vaginal morcellation
- description
- In this group, after extirpation of myoma from uterus and repair of the uterine defect, myoma will be removed through the vagina with posterior colpotomy. In this group myoma will also be removed in a enclosed fashion with using endo bag.
- interventionNames
- Procedure: vaginal morcellation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Myoma Uteri * No prior abdominal surgery Exclusion Criteria: * Suspicious for malignancy * Prior abdominal surgery * no vaginal intercourse
References
Publications (0)
Data not yet available