Enclosed Electromechanical Morcellation and Vaginal Removal During Laparoscopic Myomectomy
Phase: NA
Conditions: Myoma
Sponsor: Ege University

 
Laparoscopic Enclosed Morcellation; Electromechanic Morcellation vs Vaginal 
Removal 
 
Clinical trial registry number: NCT02737553 
Document Date: 03/21/2016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Objective 
 
To compare the laparoscopic enclosed electromechanical morcellation and 
tissue removal thorough vagina with posterior colpotomy in laparoscopic 
myomectomy procedures. 
 
 
Background 
 
 
Laparoscopic tissue removal is one of the most challenging steps for the 
laparoscopic surgery. Therefore, electromechanical morcellation has long been used 
to facilitate the tissue removal especially for myomectomy and hysterectomy. 
However, electromechanical morcellation has undergone increased scrutiny because 
of important concerns related to tissue dissemination during intracorporeal power 
morcellation according to the US Food and Drug Administration (FDA) warnings in 
November 2014.  
 
Design 
 
 
Prospective randomized interventional clinical study.  
 
Methods 
 
 
We enrolled 118 patients to the study between 18 to 40 years old with an 
indication of myomectomy. These indications were infertility, pelvic pain, 
dysmenorrhea, dyspareunia, and menometrorrhagia. Seventeen patients with prior 
abdominal surgery and 4 participants without previous vaginal intercourse were 
excluded from the study. After exclusions, 97 participants randomized into two 
groups according to sequential randomization; Group 1 (n:49): Enclosed 

Electromechanical Morcellation (EEM) and Group 2 (n:48): Vaginal Morcellation 
(VM).  
 
Statistical Analysis Plan (SAP) 
 
Categorical variables will be analyzed with frequency tables, and descriptive 
statistics will be calculated for continuous variables. The Shapiro-Wilk normality test 
will be used to analyze whether continuous data were normally distributed. As the 
data not normally distributed, Mann-Whitney U test will be used for comparison of 
two independent groups; Wilcoxon signed rank test will be used to compare two 
dependent groups. The significance level is taken as 0.05 in all hypothesis tests. All 
statistical analyses will be performed using the IBM SPSS Version 25.0 statistical 
package program.