Laparoscopic Enclosed Morcellation; Electromechanic Morcellation vs Vaginal Removal
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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.). |
Procedure: 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.).
|
| Active Comparator: 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- Operation Time [1 day]
Total operation time will be compared between two groups in seconds.
Secondary Outcome Measures
- Morcellation Time [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.
Other Outcome Measures
- Postoperative Pain [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.
- Sexual Functional Assessment [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Myoma Uteri
-
No prior abdominal surgery
Exclusion Criteria:
-
Suspicious for malignancy
-
Prior abdominal surgery
-
no vaginal intercourse
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Obstetrics and Gynecology, Ege University School of Medicine | Izmir | Bornova | Turkey | 35100 |
Sponsors and Collaborators
- Ege University
Investigators
- Principal Investigator: Ali Akdemir, MD, Ege University
Study Documents (Full-Text)
More Information
Publications
None provided.- AAkdemir1
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Seventeen patients with prior abdominal surgery and 4 participants without previous vaginal intercourse were excluded from the study. |
| Arm/Group Title | Enclosed Morcellation | Vaginal Morcellation |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 49 | 48 |
| COMPLETED | 49 | 48 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Enclosed Morcellation | Vaginal Morcellation | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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 of all reporting groups |
| Overall Participants | 49 | 48 | 97 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
36.8
(5.9)
|
35.5
(3.2)
|
36.2
(4.8)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
49
100%
|
48
100%
|
97
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
| BMI (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
24.6
(2.9)
|
26.6
(5.2)
|
25.6
(4.3)
|
Outcome Measures
| Title | Operation Time |
|---|---|
| Description | Total operation time will be compared between two groups in seconds. |
| Time Frame | 1 day |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Enclosed Morcellation | Vaginal Morcellation |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 49 | 48 |
| Mean (Standard Deviation) [seconds] |
146.1
(31.6)
|
124.6
(35.4)
|
| Title | Morcellation Time |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Enclosed Morcellation | Vaginal Morcellation |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 49 | 48 |
| Mean (Standard Deviation) [seconds] |
25.94
(8.1)
|
20.79
(6.9)
|
| Title | Postoperative Pain |
|---|---|
| Description | 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. |
| Time Frame | 2 day |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Enclosed Morcellation | Vaginal Morcellation |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 49 | 48 |
| Mean (Standard Deviation) [score on a scale] |
1.7
(1.6)
|
1.6
(1.38)
|
| Title | Sexual Functional Assessment |
|---|---|
| Description | 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. |
| Time Frame | 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Enclosed Morcellation | Vaginal Morcellation |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 49 | 48 |
| Mean (Standard Deviation) [score on a scale] |
18.4
(9.9)
|
25.3
(4.3)
|
Adverse Events
| Time Frame | 3 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Enclosed Morcellation | Vaginal Morcellation | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
| Enclosed Morcellation | Vaginal Morcellation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/49 (0%) | 0/48 (0%) | ||
Serious Adverse Events |
||||
| Enclosed Morcellation | Vaginal Morcellation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/49 (0%) | 0/48 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Enclosed Morcellation | Vaginal Morcellation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/49 (0%) | 0/48 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Ali Akdemir |
|---|---|
| Organization | Ege University |
| Phone | +905056748904 |
| md.aliakdemir@gmail.com |
- AAkdemir1