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

Ain Shams University

Status: Enrolling

Conditions: Total Laparoscopic Hysterectomy

Treatments: Procedure: Total laparoscopic hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06867614

FMASU MS 34/2025

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Vaginal approach

Active Comparator group

Description:

Closure of vaginal vault after delivery of the specimen by vaginal suturing

Treatment:

Procedure: Total laparoscopic hysterectomy

Laparoscopic approach

Active Comparator group

Description:

Closure of vaginal vault after delivery of the specimen by laparoscopic suturing

Treatment:

Procedure: Total laparoscopic hysterectomy