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

Laparoscopic Versus Transvaginal Closure of the Vaginal Vault After Total Laparoscopic Hysterectomy - a Single Blinded Randomized Comparative Study

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.

Study Overview

• Status: Recruiting
• Conditions: Total Laparoscopic Hysterectomy
• Intervention / Treatment: Procedure: Total laparoscopic hysterectomy

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rowan A Sakr; Phone Number: +201026141345; Email: 150232@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain Shams University Maternity Hospital

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vaginal approach; Closure of vaginal vault after delivery of the specimen by vaginal suturing	Procedure: Total laparoscopic hysterectomy; Removal of uterus and cervix by laparoscope
Active Comparator: Laparoscopic approach; Closure of vaginal vault after delivery of the specimen by laparoscopic suturing	Procedure: Total laparoscopic hysterectomy; Removal of uterus and cervix by laparoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal Vault hematoma	It will be assessed by examination and ultrasound	From 10 days postoperative to 30 days postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2025
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): January 19, 2026

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: FMASU MS 34/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No