Clinical trial NCT02737553: Laparoscopic Enclosed Morcellation; Electromechanic Morcellation vs Vaginal Removal
Official title: Enclosed Electromechanical Morcellation and Vaginal Removal During Laparoscopic Myomectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myoma
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Myoma Uteri
* No prior abdominal surgery

Exclusion Criteria:

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

Primary outcomes:
measure: Operation Time
timeFrame: 1 day
Secondary outcomes:
measure: Morcellation Time
timeFrame: 1 day
Other outcomes:
measure: Postoperative Pain
timeFrame: 2 day
measure: Sexual Functional Assessment
timeFrame: 3 months
Locations:
city: Izmir
country: Turkey
facility: Department of Obstetrics and Gynecology, Ege University School of Medicine
state: Bornova
Study officials:
affiliation: Ege University
name: Ali Akdemir, MD
role: PRINCIPAL_INVESTIGATOR
References: