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NCT Number: NCT06867614

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

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.

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Key information

Conditions

Total Laparoscopic Hysterectomy

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University maternity hospital

Cairo, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total laparoscopic hysterectomy

Procedure

Removal of uterus and cervix by laparoscope

Primary outcomes

  1. Vaginal Vault hematoma

    Time frame: From 10 days postoperative to 30 days postoperative

    It will be assessed by examination and ultrasound

Secondary outcomes

  1. Bleeding/spotting

    Time frame: From 10 days postoperative to 30 days postoperative

    I wil be assed by history and examination

  2. Vaginal infection:

    Time frame: From 10 days postoperative to 30 days postoperative

    It will be assessed by history and examination

  3. Vaginal prolapse

    Time frame: From 10 days postoperative to 30 days postoperative

    It will be assessed by history and examination

  4. Vaginal cuff granulation

    Time frame: From 10 days postoperative to 30 days postoperative

    It will be assessed by examination and ultrasound

  5. Sexual dysfunction

    Time frame: From 3 to 4 months post operative

    I will be assessed through Female Sexual Function Index (FSFI) questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Rowan A Sakr

CONTACT

[email protected]

+201026141345

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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