Abdominal Versus Vaginal Bisection in Laparoscopic Hysterectomy

Not Applicable

Completed

• Conditions: Laparoscopy; Hysterectomy; Uterine Bisection; Large Uteri
• Interventions: Procedure: Abdominal bisection; Procedure: Vaginal bisection

• Registration Number: NCT04904822
• Lead Sponsor: Tanta University

Brief 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

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 Timeline

• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-27
• Study Start: 2021-06-01
• Primary Completion: 2023-10-31
• Study Completion: 2024-01-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Abdominal bisection	Abdominal bisection
Study group	Vaginal bisection	Vaginal bisection of uterus

Primary Outcome Measures

Name	Time	Method
Retrieval time of uterus	6 months	Time from end of colpotomy to extraction of uterus
Blood loss	6 months	Amount of blood in suction

Secondary Outcome Measures

Name	Time	Method
Injury of other organs	6 months	Number of cases with intraoperative injuries

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, Gharbia, Egypt