Laparoscopic Versus Vaginal Cuff Closure During LH in Benign Gynecological Lesions

Not Applicable

Recruiting

• Conditions: Uterine Diseases
• Interventions: Procedure: Cuff closure via vaginal route group; Procedure: Bakay purse string

• Registration Number: NCT05823935
• Lead Sponsor: Mansoura University

Brief Summary

To compare vaginal cuff closure via Bakay purse string with vaginal cuff closure via vaginal route with continuous locked suturing after total laparoscopic hysterectomy for benign lesions.

Detailed Description

The objective of the present study is to compare 2 different methods for vaginal cuff closure after total laparoscopic hysterectomy for benign lesions regarding operative time, vaginal length, vaginal cuff dehiscene, hematoma formation. The first method is the Bakay purse string and the second is the closure of the vault via vaginal route with continuous locked suturing.

Study Timeline

• Study Start: 2022-11-05
• Status Verified: 2023-04
• Study First Submitted: 2023-04-09
• Study First Submitted QC: 2023-04-09
• Last Update Submitted: 2023-04-09
• Study First Posted: 2023-04-21
• Last Update Posted: 2023-04-21
• Primary Completion: 2023-11
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Benign uterine lesions e.g fibroid, adenomyosis,...etc.
• Patient acceptance to undergo laparoscopic hysterectomy.

Exclusion Criteria

• Gynecological malignancy.
• Low corporeal myoma obsecuring cervicovaginal junction.
• History of extensive abdominal surgery other than cesarean section.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cuff closure via vaginal route group	Cuff closure via vaginal route group	Vaginal cuff closure via vaginal route with continuous locked suturing will be used to close the vaginal cuff after total laparoscopic hysterectomy for benign lesions.
Bakay purse string group	Bakay purse string	Bakay purse string will be used to close the vaginal cuff after total laparoscopic hysterectomy for benign lesions.

Primary Outcome Measures

Name	Time	Method
Operative time for colpotomy and vaginal cuff closure	From start colpotomy to end of vaginal cuff closure	The time between first anchor suture placement and successful closure of the vaginal cuff
Total operative time	From start to end of operation	The time between placement of the operative ports and successful closure of the vaginal cuff

Trial Locations

Locations (1)

Obstetrics and Gynecology Department in Mansoura University Hospital; 🇪🇬 Mansourah, Dakahlia, Egypt