Laparoscopic Enclosed Morcellation; Electromechanic Morcellation vs Vaginal Removal

NCT02737553 | Completed Results DMC

• 1 other identifier: AAkdemir1
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myoma

Outcome Measures

Primary Outcomes (1)

• Operation Time

  Total operation time will be compared between two groups in seconds.

  1 day

Secondary Outcomes (1)

• Morcellation Time

  1 day

Other Outcomes (2)

• Postoperative Pain

  2 day

• Sexual Functional Assessment

  3 months

Study Arms (2)

enclosed morcellation

ACTIVE COMPARATOR

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.).

Procedure: Enclosed morcellation

vaginal morcellation

ACTIVE COMPARATOR

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.

Procedure: vaginal morcellation

Interventions

Enclosed morcellation PROCEDURE

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.).

enclosed morcellation

vaginal morcellation PROCEDURE

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.

vaginal morcellation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Myoma Uteri
• No prior abdominal surgery

You may not qualify if:

• Suspicious for malignancy
• Prior abdominal surgery
• no vaginal intercourse

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Ege University School of Medicine

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Ali Akdemir
• Organization: Ege University

md.aliakdemir@gmail.com

+905056748904

Study Officials

• Ali Akdemir, MD

  Ege University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ali Akdemir MD

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: April 14, 2016
• Study Start: October 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: January 24, 2022
• Results First Posted: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)