Laparoscopic Hysterectomy With Prior Uterine Artery Ligation

Sponsor

National Research Centre, Egypt (Other)

Overall Status

Completed

CT.gov ID

NCT04522232

Collaborator

Helwan University (Other), Cairo University (Other), Al-Azhar University (Other)

127

Enrollment

Location

Arms

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Artery Injury Hysterectomy	Procedure: conventional Total laparoscopic hysterectomy Procedure: Total laparoscopic hysterectomy with prior uterine artery ligation at its origin	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

127 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Laparoscopic Hysterectomy With Prior Uterine Artery Ligation vs Conventional Laparoscopic Hysterectomy

Actual Study Start Date :

Dec 1, 2017

Actual Primary Completion Date :

Feb 29, 2020

Actual Study Completion Date :

May 31, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

blood loss [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.
operation time [during the Laparoscopy]
start time is the insertion of 10 mm telescope trocar end-time is the removal of all trocars

Secondary Outcome Measures

intraoperative or postoperative complications [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al-Azhar university hospital (new Damietta)	Damietta		Egypt

Sponsors and Collaborators

National Research Centre, Egypt
Helwan University
Cairo University
Al-Azhar University

Investigators

Principal Investigator: Mazen Abdel-Rasheed, National research centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mazen Abdel Rasheed, Principal Investigator, National Research Centre, Egypt

ClinicalTrials.gov Identifier:

NCT04522232

Other Study ID Numbers:

Uterine artery ligation in TLH

First Posted:

Aug 21, 2020

Last Update Posted:

Aug 21, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mazen Abdel Rasheed, Principal Investigator, National Research Centre, Egypt

Hysterectomy

Laparoscopy

Uterine Artery Ligation

Study Results

No Results Posted as of Aug 21, 2020