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Laparoscopic Enclosed Morcellation; Electromechanic Morcellation vs Vaginal Removal

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ClinicalTrials.gov Identifier: NCT02737553
Recruitment Status : Unknown
Verified April 2016 by Ali Akdemir, Ege University.
Recruitment status was:  Recruiting
First Posted : April 14, 2016
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
Ali Akdemir, Ege University

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
Myoma Procedure: Enclosed morcellation Procedure: vaginal morcellation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: Enclosed Electromechanical Morcellation and Vaginal Removal During Laparoscopic Myomectomy
Study Start Date : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

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.




Primary Outcome Measures :
  1. Operation time [ Time Frame: 1 day ]
    Total operation time will be compared between two groups in seconds.


Secondary Outcome Measures :
  1. Morcellation time [ Time Frame: 1 day ]
    Tissue morcellation time will be compared between two groups in seconds.


Other Outcome Measures:
  1. Postoperative pain [ Time Frame: 2 day ]
    Postoperative pain will be compared between two groups using visual analog score in 0 to 10 scale.

  2. Sexual functional assessment [ Time Frame: 3 months ]
    Sexual function will be assessed with using "Female Sexual Function Index questionnaire" and it will be compared between two groups.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Myoma Uteri
  • No prior abdominal surgery

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737553


Contacts
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Contact: Ali Akdemir, MD +905056748904 md.aliakdemir@gmail.com

Locations
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Turkey
Department of Obstetrics and Gynecology, Ege University School of Medicine Recruiting
Izmir, Bornova, Turkey, 35100
Contact: Ali Akdemir, MD    +905056748904    md.aliakdemir@gmail.com   
Contact: Cagdas Sahin, MD    +902323901700    cagdasdr@yahoo.com   
Principal Investigator: Ali Akdemir, MD         
Sub-Investigator: Cagdas Sahin, MD         
Principal Investigator: Fatih Sendag, MD         
Sub-Investigator: Enes Taylan, MD         
Sponsors and Collaborators
Ege University
Investigators
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Principal Investigator: Ali Akdemir, MD Ege University

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Responsible Party: Ali Akdemir, Ali Akdemir MD, Ege University
ClinicalTrials.gov Identifier: NCT02737553     History of Changes
Other Study ID Numbers: AAkdemir1
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No