Laparoscopic Versus Vaginal Cuff Closure During LH in Benign Gynecological Lesions

Uterine Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05823935
• Other study ID #: MD.22.10.703
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2022
• Est. completion date: November 2023

Study information

• Verified date: April 2023
• Source: Mansoura University
• Contact: Ahmed M Elashry, MSc
• Phone: +201066556370
• Email: elashry11090[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Uterine Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Obstetrics and Gynecology Department in Mansoura University Hospital	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total operative time	The time between placement of the operative ports and successful closure of the vaginal cuff	From start to end of operation
Primary	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