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

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: Hysterectomy; Laparoscopy; Uterine Bisection; Large Uteri
• Intervention / Treatment: Procedure: Vaginal bisection; Procedure: Abdominal bisection

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

• Study Contact: Name: Ayman Dawood, MD; Phone Number: +202020972067; Email: ayman.dawood@med.tanta.edu.eg
• Study Contact Backup: Name: Adel Elgergawy, MD; Phone Number: +201002057250; Email: dradelali775@gmail.com

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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 from end of colpotomy to extraction of uterus	6 months
Blood loss	Amount of blood in suction	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

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