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

NCT ID: NCT06867614

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-14

Study Completion Date

2026-01-19

Brief Summary

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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

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Conditions

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Total Laparoscopic Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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Vaginal approach

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

Group Type ACTIVE_COMPARATOR

Total laparoscopic hysterectomy

Intervention Type PROCEDURE

Removal of uterus and cervix by laparoscope

Laparoscopic approach

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

Group Type ACTIVE_COMPARATOR

Total laparoscopic hysterectomy

Intervention Type PROCEDURE

Removal of uterus and cervix by laparoscope

Interventions

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Total laparoscopic hysterectomy

Removal of uterus and cervix by laparoscope

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Rowan Ashraf AbdelHady Sakr

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University maternity hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Rowan A Sakr

Role: CONTACT

+201026141345

Other Identifiers

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FMASU MS 34/2025

Identifier Type: -

Identifier Source: org_study_id

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