Laparoscopic Hysterectomy With Prior Uterine Artery Ligation

NCT04522232 | Completed

• 1 other identifier: Uterine artery ligation in TLH
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Artery Injury; Hysterectomy

Keywords

Hysterectomy; Laparoscopy; Uterine Artery Ligation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• intraoperative or postoperative complications

  during the Laparoscopy and during the hospital stay (24 hours postoperative)

Study Arms (2)

group A

PLACEBO COMPARATOR

women that underwent conventional Total laparoscopic hysterectomy

Procedure: conventional Total laparoscopic hysterectomy

group B

EXPERIMENTAL

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

Interventions

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.

group A

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

group B

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• fibroid uterus
• endometrial hyperplasia with failed hormonal therapy
• DUB with failed medical and hormonal treatment
• uterine prolapse.

You may not qualify if:

• gynecologic malignancy
• presence of contraindications to laparoscopy.

Sponsors & Collaborators

• National Research Centre, Egypt: lead
• Helwan University: collaborator
• Cairo University: collaborator
• Al-Azhar University: collaborator

Study Sites (1)

Al-Azhar university hospital (new Damietta)

Damietta, Egypt

Location

Study Officials

• Mazen Abdel-Rasheed

  National Research Centre, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 21, 2020
• Study Start: December 1, 2017
• Primary Completion: February 29, 2020
• Study Completion: May 31, 2020
• Last Updated: October 4, 2022

Record last verified: 2022-10

Locations

EG (1)