Uterine Artery Ligation at Origin in Total Laparscopic Hystrectomy

NCT04808583 | Completed

• 1 other identifier: UALO20
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current study is to compare between the uterine artery ligation at its origin at the beginning of the operation and the conventional method after cornual pedicle regarding their efficacy to minimize operative time in patients undergoing total laparoscopic hysterectomy.

Conditions

Uterine Diseases

Keywords

laparscopic hystrectomy uterine artery operative time

Outcome Measures

Primary Outcomes (1)

• Operative time in minutes

  starting from port insertion till disconnecting the uterus from the vagina

  Intraoperative (once for each patient starting from port insertion till disconnecting the uterus from the vagina .)

Secondary Outcomes (4)

• Blood loss in millimeters

  Intraoperative (once for each patient at the end of the operation .)

• postoperative pain measured using visual analogue score.

  6 hours postoperative - 12 hours postoperative

• Hospital stay (in days)

  "through study completion, an average of 1 year".

• Complications

  during the procedure,immediately after the procedure .

Study Arms (2)

Group (A)

ACTIVE COMPARATOR

conventional TLH with uterine artery ligation after the cornual pedicles

Procedure: conventional TLH with uterine artery ligation after the cornual pedicles

Group (B)

EXPERIMENTAL

TLH with uterine artery ligation at its origin at the beginning of the operation

Procedure: TLH with uterine artery ligation at its origin at the beginning of the operation

Interventions

TLH with uterine artery ligation at its origin at the beginning of the operation PROCEDURE

After insertion of the ports and surveying the abdomen as in the conventional method a window will be created in the broad ligament to enter the retroperitoneal space with exposure of the iliac vessel and identification of the internal iliac artery and its anterior branch which give rise to the uterine artery. Blunt dissection continues with identification of the paravesical and the pararectal spaces. The ureter is identified medially and the uterine artery laterally and dissection of the ureter away from the uterine artery will be done, followed by sealing the uterine artery 2 mm from its origin from the anterior branch of internal iliac artery

Group (B)

conventional TLH with uterine artery ligation after the cornual pedicles PROCEDURE

Coagulation and section of round ligaments will be performed about 2 to 3 cm from the pelvic wall using blunt tip laparoscopic sealer LigaSure COVIDIEN (5mm-37cm) with average of sealing cycle of 2 to 4 seconds and 40 watts , followed by opening the anterior leaflet of the broad ligament to the vesico-uterine peritoneal reflection, coagulation and section of the infundibulo-pelvic ligament (total hysterectomy with bilateral adnexectomy) or of the uteroovarian ligament and the fallopian tubes (total hysterectomy). Then opening the posterior leaflet of the broad ligament to the cervix, opening of the vesico-vaginal space and dissecting the bladder downwards will be done (Poojari et al., 2014). Coagulation and section of the uterine pedicles: performed on the ascending segment of the uterine artery, will be carried out in a progressive manner on both sides.

Group (A)

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age group (35-70 years old).
• Women consenting to have a total laparoscopic hysterectomy.

You may not qualify if:

• Patients with relative contraindication to general anesthesia (e.g. chronic liver cell failure)(All laparoscopic procedures are done under GA).
• Patients with contraindication to laparoscopic surgery (e.g. severe cardio-pulmonary dysfunction).
• Bleeding tendency (e.g. anticoagulants, platelets disorders)(will affect the blood loss measurement)
• Body mass index more than 35 Kg/m2(not suitable for laparoscopic surgeries as obesity affects airway pressure )
• Uncorrected anemic patients (Hemoglobin \< 10 gm. /dl).(will affect the outcomes eg :
• Blood transfusion , hospital stay … etc )

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams maternity hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Uterine Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Hazem M Sammour, MD

  Professor of Obstetrics and Gynecology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of obstetrics and gynecology

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 22, 2021
• Study Start: July 2, 2021
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)