N/A
N=97
Laparoscopic Enclosed Morcellation; Electromechanic Morcellation vs Vaginal Removal
Myoma
Bottom Line
View on ClinicalTrials.gov: NCT02737553 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Operation Time — 146.1; 124.6 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enclosed morcellation (Procedure); vaginal morcellation (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ege University
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Operation Time |
146.1; 124.6 | — |
| SECONDARY Morcellation Time |
25.94; 20.79 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Myoma Uteri
- No prior abdominal surgery
Exclusion Criteria
- Suspicious for malignancy
- Prior abdominal surgery
- no vaginal intercourse
Data sourced from ClinicalTrials.gov (NCT02737553). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.