Laparoscopic Versus Transvaginal Closure of the Vaginal Vault After Total Laparoscopic Hysterectomy

Not Applicable

Recruiting

• Conditions: Total Laparoscopic Hysterectomy

• Registration Number: NCT06867614
• Lead Sponsor: Ain Shams University

Brief Summary

The goal of this clinical trial is to compare the laparoscopic and transvaginal closure techniques of the vaginal vault in patients who perform TLH, regarding the risk of vaginal vault hematoma and other complications as vaginal cuff infection and sexual dysfunction.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-14
• Study First Submitted: 2025-02-18
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-08-31
• Study Completion: 2026-01-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• Adult females consenting to do TLH all age groups with diagnoses of benign uterine conditions.
• Women who are non-obese (normal or overweight women with BMI range 18-29.9).
• Sexually active female.

Exclusion Criteria

• Diagnosed cases of pelvic malignancy
• Diagnosed patients with Cervical intraepithelial neoplasia (CIN) or bacterial vaginosis (any infection should be treated)
• Obese patients.
• Patients currently undergoing treatment for any type of cancer
• Patients with coagulopathy, bleeding/clotting disorders
• Patients with any condition can impair wound healing: diabetes mellites, anemia, steroids
• Patients with a previous history of radiation and allergy to sutures
• Patients with clinically evident prolapse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Vaginal Vault hematoma	From 10 days postoperative to 30 days postoperative	It will be assessed by examination and ultrasound

Secondary Outcome Measures

Name	Time	Method
Bleeding/spotting	From 10 days postoperative to 30 days postoperative	I wil be assed by history and examination
Vaginal infection:	From 10 days postoperative to 30 days postoperative	It will be assessed by history and examination
Vaginal prolapse	From 10 days postoperative to 30 days postoperative	It will be assessed by history and examination
Vaginal cuff granulation	From 10 days postoperative to 30 days postoperative	It will be assessed by examination and ultrasound
Sexual dysfunction	From 3 to 4 months post operative	I will be assessed through Female Sexual Function Index (FSFI) questionnaire

Trial Locations

Locations (1)

Ain Shams University maternity hospital; 🇪🇬 Cairo, Egypt