Laparoscopic Versus Vaginal Cuff Closure During LH in Benign Gynecological Lesions

Laparoscopic Versus Vaginal Cuff Closure During Laparoscopic Hysterectomy in Benign Gynecological Lesions

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.

Study Overview

• Status: Recruiting
• Conditions: Uterine Diseases
• Intervention / Treatment: Procedure: Bakay purse string; Procedure: Cuff closure via vaginal route group

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed M Elashry, MSc; Phone Number: +201066556370; Email: elashry11090@gmail.com
• Study Contact Backup: Name: Mohamed S Abdelhafez, MD; Email: msabdelhafez@gmail.com

Study Locations

• Egypt
  • Dakahlia
    • Mansourah, Dakahlia, Egypt, 35111
      • Recruiting
      • Obstetrics and Gynecology Department in Mansoura University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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
Active Comparator: Bakay purse string group; Bakay purse string will be used to close the vaginal cuff after total laparoscopic hysterectomy for benign lesions.	Procedure: Bakay purse string; After developing the bladder flap, Vicryl polyglactin 910 sutures (Ethicon, Inc, Somerville, NJ) will be placed on the line between the cervicovaginal junction and the bladder starting at either 4 to 3 o'clock or 8 to 9 o'clock, as anchor sutures. Paying attention not to get closer than 1 cm to the bladder, the first suture will be passed from 4 o'clock to 3 o'clock and continued circumferentially in a full-thickness purse string fashion through 3, 1, 10, 8, 7, 5 o'clock completing a circle while including both uterosacral ligaments.
Active Comparator: 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.	Procedure: Cuff closure via vaginal route group; After the uterus will be removed via vaginal route, vaginal cuff ends will be grasped via vaginal approach and sutured continuous locked sutures using Vicryl polyglactin 910 sutures in one layer.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Ahmed M Elashry, MSc, Mansoura University; Study Chair: Hamed M Youssef, MD, Mansoura University; Study Director: Maged R Elshamy, MD, Mansoura University; Study Director: Mahmoud M Awad, MD, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2022
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: April 9, 2023
• First Submitted That Met QC Criteria: April 9, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 9, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: TLH; Bakay purse string
• Additional Relevant MeSH Terms: Uterine Diseases
• Other Study ID Numbers: MD.22.10.703

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No