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NCT04904822 Clinical Trial

Abdominal Versus Vaginal Bisection in Laparoscopic Hysterectomy

Laparoscopy Clinical Trial

— TLH-Bisection  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04904822
Other study ID # uterine bisection
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date January 31, 2024

Study information
Verified date March 2024
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date January 31, 2024
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Vaginal bisection
Uterine bisection vaginally by scalpel 24
• Abdominal bisection
Uterine bisection by endokinfe

Locations
Country Name City State
Egypt Tanta University Tanta Gharbia

Sponsors (1)
Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Retrieval time of uterus Time from end of colpotomy to extraction of uterus 6 months
Primary Blood loss Amount of blood in suction 6 months
Secondary Injury of other organs Number of cases with intraoperative injuries 6 months
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