Laparoscopic Hysterectomy With Prior Uterine Artery Ligation

Study Overview
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Brief Summary
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A randomized controlled trial was done on 127 women planned for TLH, and divided into two groups; group A includes women that underwent conventional TLH, and group B includes women that underwent TLH with prior uterine artery ligation at its origin. Both grouped were compared regarding the blood loss, operation time, intraoperative complications and post-operative follow-up.

Official Title
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Laparoscopic Hysterectomy With Prior Uterine Artery Ligation vs Conventional Laparoscopic Hysterectomy

Conditions
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Uterine Artery Injury, Hysterectomy

Intervention / Treatment
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* Procedure: conventional Total laparoscopic hysterectomy
* Procedure: Total laparoscopic hysterectomy with prior uterine artery ligation at its origin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: any benign uterine pathology such as: fibroid uterus endometrial hyperplasia with failed hormonal therapy DUB with failed medical and hormonal treatment uterine prolapse. Exclusion Criteria: gynecologic malignancy presence of contraindications to laparoscopy.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: group A<br>women that underwent conventional Total laparoscopic hysterectomy | Procedure: conventional Total laparoscopic hysterectomy<br>* the ascending branch of the uterine artery was identified close to the isthmus then ligated at this level, close to the uterus or coagulated, using bipolar diathermy. The utero-vesical fold was dissected and the bladder was pushed down done, thus moving the ureters laterally, which decreases the risk of including them in a suture. The vasculature of the uterus is now secured and this is evidenced by the pale color of the fundus. Using either bipolar diathermy or the harmonic ultracision, the cornual pedicles on one side were desiccated and cut. Also, both the uterosacral and cardinal ligaments were desiccated and cut. So that, the opposite side pedicles can be taken care of, the direction of manipulator was changed. The infundibulopelvic ligaments were desiccated and cut if it is necessary to remove both ovaries. A vaginal cuff was inserted into the vagina to identify the vault, which was then cut laparoscopically using a monopolar hook, where the specimen was completely detached.<br>|
| Experimental: group B<br>women that underwent Total laparoscopic hysterectomy with prior uterine artery ligation at its origin | Procedure: Total laparoscopic hysterectomy with prior uterine artery ligation at its origin<br>* the uterine artery was dissected using the lateral approach; where dissection begins from the anterior leaf of the broad ligament. The triangle enclosed by the round ligament, external iliac artery, and infundibulopelvic ligament was opened. The areolar space was dissected and the origin of the uterine artery from the internal iliac and the ureter was identified. The uterine artery was then isolated from the surrounding structures and ligated by Hem-o-lok clips. then same steps as conventional Total laparoscopic hysterectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss | The total blood loss was calculated from the suction apparatus. No irrigation was used throughout the surgery until the total blood loss was calculated. Peritoneal lavage was done with normal saline solution. | during the Laparoscopy | 
| operation time | start time is the insertion of 10 mm telescope trocar end-time is the removal of all trocars | during the Laparoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative or postoperative complications | intraoperative complications are that during the Laparoscopy postoperative complications are that during the hospital stay (24 hours postoperative) | during the Laparoscopy and during the hospital stay (24 hours postoperative) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine Artery Ligation, Hysterectomy, Laparoscopy