Laparoscopic Versus Transvaginal Closure of the Vaginal Vault After Total Laparoscopic Hysterectomy
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 14, 2025
CompletedFirst Submitted
Initial submission to the registry
February 18, 2025
CompletedFirst Posted
Study publicly available on registry
March 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2026
CompletedMarch 10, 2025
March 1, 2025
8 months
February 18, 2025
March 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Vaginal Vault hematoma
It will be assessed by examination and ultrasound
From 10 days postoperative to 30 days postoperative
Secondary Outcomes (5)
Bleeding/spotting
From 10 days postoperative to 30 days postoperative
Vaginal infection:
From 10 days postoperative to 30 days postoperative
Vaginal prolapse
From 10 days postoperative to 30 days postoperative
Vaginal cuff granulation
From 10 days postoperative to 30 days postoperative
Sexual dysfunction
From 3 to 4 months post operative
Study Arms (2)
Vaginal approach
ACTIVE COMPARATORClosure of vaginal vault after delivery of the specimen by vaginal suturing
Laparoscopic approach
ACTIVE COMPARATORClosure of vaginal vault after delivery of the specimen by laparoscopic suturing
Interventions
Removal of uterus and cervix by laparoscope
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University maternity hospital
Cairo, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
February 18, 2025
First Posted
March 10, 2025
Study Start
January 14, 2025
Primary Completion
August 31, 2025
Study Completion
January 19, 2026
Last Updated
March 10, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share