Laparoscopic Versus Vaginal Cuff Closure During LH in Benign Gynecological Lesions

NCT05823935 | Unknown

• 1 other identifier: MD.22.10.703
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Diseases

Keywords

TLH; Bakay purse string

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Bakay purse string group

ACTIVE COMPARATOR

Bakay purse string will be used to close the vaginal cuff after total laparoscopic hysterectomy for benign lesions.

Procedure: Bakay purse string

Cuff closure via vaginal route group

ACTIVE COMPARATOR

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

Interventions

Bakay purse string PROCEDURE

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.

Bakay purse string group

Cuff closure via vaginal route group PROCEDURE

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.

Cuff closure via vaginal route group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Obstetrics and Gynecology Department in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

RECRUITING

MeSH Terms

Conditions

Uterine Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ahmed M Elashry, MSc

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Hamed M Youssef, MD

  Mansoura University

  STUDY CHAIR

• Maged R Elshamy, MD

  Mansoura University

  STUDY DIRECTOR

• Mahmoud M Awad, MD

  Mansoura University

  STUDY DIRECTOR

• Mohamed S Abdelhafez, MD

  Mansoura University

  STUDY DIRECTOR

Central Study Contacts

Ahmed M Elashry, MSc

CONTACT

+201066556370; elashry11090@gmail.com

Mohamed S Abdelhafez, MD

CONTACT

msabdelhafez@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2023
• First Posted: April 21, 2023
• Study Start: November 5, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

EG (1)