Laparoscopic Hysterectomy With Prior Uterine Artery Ligation

Laparoscopic Hysterectomy With Prior Uterine Artery Ligation vs Conventional Laparoscopic Hysterectomy

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.

Study Overview

• Status: Completed
• Conditions: Hysterectomy; Uterine Artery Injury
• Intervention / Treatment: Procedure: conventional Total laparoscopic hysterectomy; Procedure: Total laparoscopic hysterectomy with prior uterine artery ligation at its origin

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Damietta, Egypt
    • Al-Azhar university hospital (new Damietta)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: group A; women that underwent conventional Total laparoscopic hysterectomy	Procedure: conventional Total laparoscopic hysterectomy; 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.
EXPERIMENTAL: group B; 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; 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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: National Research Centre, Egypt
• Collaborators: Cairo University; Al-Azhar University; Helwan University
• Investigators: Principal Investigator: Mazen Abdel-Rasheed, National Research Centre, Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2017
• Primary Completion (ACTUAL): February 29, 2020
• Study Completion (ACTUAL): May 31, 2020

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (ACTUAL): August 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 2, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Laparoscopy; Hysterectomy; Uterine Artery Ligation
• Other Study ID Numbers: Uterine artery ligation in TLH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No