Trial Outcomes & Findings for Laparoscopic Enclosed Morcellation; Electromechanic Morcellation vs Vaginal Removal (NCT NCT02737553)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

118 participants

Primary outcome timeframe

1 day

Results posted on

2022-01-24

Participant Flow

Seventeen patients with prior abdominal surgery and 4 participants without previous vaginal intercourse were excluded from the study.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	49	48
Overall Study COMPLETED	49	48
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enclosed Morcellation n=49 Participants 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.	Vaginal Morcellation n=48 Participants 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.	Total n=97 Participants Total of all reporting groups
Age, Continuous	36.8 years STANDARD_DEVIATION 5.9 • n=49 Participants	35.5 years STANDARD_DEVIATION 3.2 • n=48 Participants	36.2 years STANDARD_DEVIATION 4.8 • n=97 Participants
Sex: Female, Male Female	49 Participants n=49 Participants	48 Participants n=48 Participants	97 Participants n=97 Participants
Sex: Female, Male Male	0 Participants n=49 Participants	0 Participants n=48 Participants	0 Participants n=97 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI	24.6 kg/m^2 STANDARD_DEVIATION 2.9 • n=49 Participants	26.6 kg/m^2 STANDARD_DEVIATION 5.2 • n=48 Participants	25.6 kg/m^2 STANDARD_DEVIATION 4.3 • n=97 Participants

PRIMARY outcome

Timeframe: 1 day

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

Outcome measures

Outcome measures
Measure	Enclosed Morcellation n=49 Participants 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.	Vaginal Morcellation n=48 Participants 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.
Operation Time	146.1 seconds Standard Deviation 31.6	124.6 seconds Standard Deviation 35.4

SECONDARY outcome

Timeframe: 1 day

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.

Outcome measures

Outcome measures
Measure	Enclosed Morcellation n=49 Participants 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.	Vaginal Morcellation n=48 Participants 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.
Morcellation Time	25.94 seconds Standard Deviation 8.1	20.79 seconds Standard Deviation 6.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 day

Postoperative pain was compared between two groups using visual analog score in 0 to 10 scale. Participants were assessed in terms of pain with the Visual Pain Scale (VAS). The participants were asked to rate current pain on a 10-cm visual analog scale (VAS), with 0 being no pain and 10 the worst pain imaginable 48 hours after operation.

Outcome measures

Outcome measures
Measure	Enclosed Morcellation n=49 Participants 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.	Vaginal Morcellation n=48 Participants 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.
Postoperative Pain	1.7 score on a scale Standard Deviation 1.6	1.6 score on a scale Standard Deviation 1.38

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Sexual function will be assessed with using "Female Sexual Function Index questionnaire" and it will be compared between two groups. Participants were requested to fill FSFI (Female Sexual Function Index) forms to evaluate their sexual lives. The FSFI consists of 19 questions and is a validated questionnaire for the assessment of sexual function. The questions are grouped into the subdomains of libido, arousal, lubrication, orgasm, satisfaction, and pain. The total score is determined by summing up the subdomains scores. Higher scores reflect better sexual function; maximum score is 36 and minimum score is 0. For each subdomain, higher scores reflect better sexual function; maximum score is 6 and minimum score is 0 including pain, in which 0 reflects lots of pain and 6 reflects the absence of pain.

Outcome measures

Outcome measures
Measure	Enclosed Morcellation n=49 Participants 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.	Vaginal Morcellation n=48 Participants 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.
Sexual Functional Assessment	18.4 score on a scale Standard Deviation 9.9	25.3 score on a scale Standard Deviation 4.3

Adverse Events

Enclosed Morcellation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vaginal Morcellation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ali Akdemir

Ege University

Phone: +905056748904

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place