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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
118
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.).
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.
Department of Obstetrics and Gynecology, Ege University School of Medicine
Izmir, Bornova, Turkey (Türkiye)
Operation Time
Total operation time will be compared between two groups in seconds.
Time frame: 1 day
Morcellation Time
After extirpation of the myoma in group 1 the fibroid was placed into the glove within the abdomen. The morcellation was accomplished within the completely enclosed glove. In Group 2, after extirpation of the myoma, it was removed through the vagina through posterior colpotomy. An endoscopic specimen bag was placed into the abdomen following the vaginal posterior colpotomy. Then, the fibroid was placed into the endoscopic bag within the abdomen. The specimen was removed with coring technique via scalpel. Posterior colpotomy incision was then sutured vaginally. Morcellation time is decided time between the insertion and removal of the surgical glove in group 1 and time between start of the posterior colpotomy and end of the closure of the posterior colpotomy in group 2. Tissue morcellation time compared between two groups in seconds.
Time frame: 1 day
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