Retroperitoneal Ligation of Uterine Artery in Total Laparoscopic Hysterectomy for Enlarged Uterus

Study Overview
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Brief Summary
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This randomized trial is aimed to investigate the role of retroperitoneal TLH in enlarge uterus.

Detailed Description
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Laparoscopic hysterectomy is one of the most common gynecologic surgeries worldwide. Generally, in total laparoscopic hysterectomy (TLH), uterine arteries are coagulated or transected close to the uterus, alongside the cervix, like surgical technique of a conventional total abdominal hysterectomy. Recently, several studies showed that ligation of uterine artery where it originates from the internal iliac artery during TLH (so-called retroperitoneal TLH) is effective for reducing blood loss. However, the application of this technique to clinical practice have not been well investigated in terms of its efficacy and safety. Moreover, most of the previous studies on retroperitoneal TLH were small case series or retrospective comparative studies with conventional TLH. Therefore, the investigators conducted this randomized trial to investigate the role of retroperitoneal TLH in enlarge uterus.

Official Title
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Retroperitoneal Ligation of Uterine Artery in Total Laparoscopic Hysterectomy for Enlarged Uterus: A Randomized Controlled Trial

Conditions
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Hysterectomy

Intervention / Treatment
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* Procedure: Retroperitoneal liagation of uterine artery
* Procedure: Classical ligation of uterine artery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: absence of pregnancy at the time of presentation uterine volume between 12 and 18 weeks of gestation by pelvic examination appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2) Exclusion Criteria: any suggestion of malignant uterine or adnexal diseases any major medical comorbidities or psychiatric illnesses, which could affect follow-up and/or compliance an inability to understand and provide written informed consent.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Retroperitoneal hysterectomy<br>In subjects allocated to the experimental group, which the uterine vessels were ligated where it originates from the internal iliac artery, | Procedure: Retroperitoneal liagation of uterine artery<br>* the site of ligation of uterine artery is the area that it originates from the internal iliac artery during TLH<br>|
| Active Comparator: Classical hysterectomy<br>The operative technique of classical total laparoscopic hysterectomy (TLH) performed in the control group was comparable to that of retroperitoneal TLH, except for one that coagulation and transection of uterine artery was achieved using an energy device alongside the cervix | Procedure: Classical ligation of uterine artery<br>* the site of ligation of uterine artery is the area alongside the cervix<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative blood loss | Operative blood loss was calculated by the anesthesiology unit as the difference between the total amount of suction and irrigation plus the difference between the total gauze weight before and after surgery. | Operation day |