Laparoscopic Enclosed Morcellation; Electromechanic Morcellation vs Vaginal Removal

NCT ID: NCT02737553

Last Updated: 2022-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2020-02-29

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.

Detailed Description

In this study researchers aiming to compare the compare the laparoscopic enclosed electromechanical morcellation and tissue removal thorough vagina with posterior colpotomy according to surgical time, postoperative pain and postoperative sexual function.

Patients with an indication of myomectomy, between 18 to 40 years old, without prior abdominal surgery and without suspicious of malignancy will include into the study. Anticipated number of the patients will be 60. Participants will be randomized into two groups; group 1 enclosed electromechanical morcellation will be performed to remove the myoma out of the abdominal cavity; group 2 myoma will be removed through vagina with posterior colpotomy. In group 1, 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 with using surgical glove. In group 2, 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. Tissue removal time (for group 1 removal time is decided time between the insertion and removal of the morcellation, for group two removal time is decided time between start of the posterior colpotomy and end of the closure of the posterior colpotomy), postoperative time and sexual function of the patient and any of the complications will be compared. Visual pain score and female sexual function index questionnaire will be used to assess the postoperative pain and sexual function, respectively.

Conditions

Myoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

enclosed morcellation

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.).

Group Type: ACTIVE_COMPARATOR

Enclosed morcellation

Intervention Type: 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.).

vaginal morcellation

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.

Group Type: ACTIVE_COMPARATOR

vaginal morcellation

Intervention Type: 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.

Interventions

Enclosed morcellation

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.).

Intervention Type: PROCEDURE

vaginal morcellation

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Myoma Uteri
• No prior abdominal surgery

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Ali Akdemir

Ali Akdemir MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Akdemir, MD

Role: PRINCIPAL_INVESTIGATOR

Ege University

Locations

Department of Obstetrics and Gynecology, Ege University School of Medicine

Izmir, Bornova, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AAkdemir1

Identifier Type: -

Identifier Source: org_study_id