Abdominal Versus Vaginal Bisection in Laparoscopic Hysterectomy (TLH-Bisection)

March 11, 2024 updated by: Ayman S Dawood, MD, Tanta University

Abdominal Versus Vaginal Uterine Bisection for Retrieval of Large Uteri During Laparoscopic Hysterectomy: A Randomized Controlled Study

Large uteri present a challenge during Total lap.hysterectomy and its extraction is another challenge. This study addressees and compare 2 methods of retrieval of large uteri

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite a number of publications about TLH for large uterus, few surgeons have compared the results of their technique of TLH through the vagina or abdominal bisection. The aim of this study was to compare the clinical results of TLH for large uterus through transvaginal or abdominal bisection approaches after strict preoperative assessment.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Gharbia
      • Tanta, Gharbia, Egypt, 31111
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • large uterus ≥ 12weeks,
  • benign pathology,
  • mobile uterus
  • BMI less than 30kg/m2

Exclusion Criteria:

  • unfit for laparoscopy,
  • Extensive pelvic adhesions,
  • Extensive endometriosis
  • malignancy
  • virgin cases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Vaginal bisection of uterus
Procedure: Vaginal bisection
Uterine bisection vaginally by scalpel 24
Experimental: Control group
Abdominal bisection
Procedure: Abdominal bisection
Uterine bisection by endokinfe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retrieval time of uterus
Time Frame: 6 months
Time from end of colpotomy to extraction of uterus
6 months
Blood loss
Time Frame: 6 months
Amount of blood in suction
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Injury of other organs
Time Frame: 6 months
Number of cases with intraoperative injuries
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

May 24, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • uterine bisection

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

we will share results and statistical analysis on valuable request

IPD Sharing Time Frame

3 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe