Myoma Clinical Trial
Official title:
Enclosed Electromechanical Morcellation and Vaginal Removal During Laparoscopic Myomectomy
NCT number | NCT02737553 |
Other study ID # | AAkdemir1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | February 2020 |
Verified date | February 2021 |
Source | Ege University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 118 |
Est. completion date | February 2020 |
Est. primary completion date | February 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Myoma Uteri - No prior abdominal surgery Exclusion Criteria: - Suspicious for malignancy - Prior abdominal surgery - no vaginal intercourse |
Country | Name | City | State |
---|---|---|---|
Turkey | Department of Obstetrics and Gynecology, Ege University School of Medicine | Izmir | Bornova |
Lead Sponsor | Collaborator |
---|---|
Ege University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Postoperative Pain | 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. |
2 day | |
Other | Sexual Functional Assessment | 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. |
3 months | |
Primary | Operation Time | Total operation time will be compared between two groups in seconds. | 1 day | |
Secondary | 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. |
1 day |
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