Laparoscopic Hysterectomy With Prior Uterine Artery Ligation

NCT ID: NCT04522232

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2020-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group A

women that underwent conventional Total laparoscopic hysterectomy

Group Type: PLACEBO_COMPARATOR

conventional Total laparoscopic hysterectomy

Intervention Type: 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 B

women that underwent Total laparoscopic hysterectomy with prior uterine artery ligation at its origin

Group Type: EXPERIMENTAL

Total laparoscopic hysterectomy with prior uterine artery ligation at its origin

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Helwan University

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: collaborator

Al-Azhar University

OTHER

Sponsor Role: collaborator

National Research Centre, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Mazen Abdel Rasheed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mazen Abdel-Rasheed

Role: PRINCIPAL_INVESTIGATOR

National Research Centre, Egypt

Locations

Al-Azhar university hospital (new Damietta)

Damietta, , Egypt

Countries

Egypt

Other Identifiers

Uterine artery ligation in TLH

Identifier Type: -

Identifier Source: org_study_id