Skip to main content
OpenTrials
Completed

NCT Number: NCT04522232

Laparoscopic Hysterectomy With Prior Uterine Artery Ligation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar university hospital (new Damietta)

Damietta, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

conventional Total laparoscopic hysterectomy

Procedure

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.

Total laparoscopic hysterectomy with prior uterine artery ligation at its origin

Procedure

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

Primary outcomes

  1. blood loss

    Time frame: during the Laparoscopy

    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.

  2. operation time

    Time frame: during the Laparoscopy

    start time is the insertion of 10 mm telescope trocar end-time is the removal of all trocars

Secondary outcomes

  1. intraoperative or postoperative complications

    Time frame: during the Laparoscopy and during the hospital stay (24 hours postoperative)

    intraoperative complications are that during the Laparoscopy postoperative complications are that during the hospital stay (24 hours postoperative)

Sponsors and collaborators

Lead sponsor

National Research Centre, Egypt

Other

Collaborators

  • Al-Azhar University
  • Cairo University
  • Helwan University

Registry information

Official study title

Laparoscopic Hysterectomy With Prior Uterine Artery Ligation vs Conventional Laparoscopic Hysterectomy

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 21, 2020
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.