Laparoscopic Hysterectomy With Prior Uterine Artery Ligation

Hysterectomy Clinical Trial

Official title:

Laparoscopic Hysterectomy With Prior Uterine Artery Ligation vs Conventional Laparoscopic Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04522232
• Other study ID #: Uterine artery ligation in TLH
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: May 31, 2020

Study information

• Verified date: October 2022
• Source: National Research Centre, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: May 31, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hysterectomy
• Uterine Artery Injury

Intervention

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.
• 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

Locations

Country	Name	City	State
Egypt	Al-Azhar university hospital (new Damietta)	Damietta

Sponsors (4)

Lead Sponsor	Collaborator
National Research Centre, Egypt	Al-Azhar University, Cairo University, Helwan University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	operation time	start time is the insertion of 10 mm telescope trocar end-time is the removal of all trocars	during the Laparoscopy
Secondary	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)