NCT06867614RecruitingNot Applicable
Laparoscopic Versus Transvaginal Closure of the Vaginal Vault After Total Laparoscopic Hysterectomy - a Single Blinded Randomized Comparative Study
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Vaginal Vault hematoma
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Participant)
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Vaginal approach
Active Comparator
Closure of vaginal vault after delivery of the specimen by vaginal suturing
Intervention: Total laparoscopic hysterectomy (Procedure)
Laparoscopic approach
Active Comparator
Closure of vaginal vault after delivery of the specimen by laparoscopic suturing
Intervention: Total laparoscopic hysterectomy (Procedure)
Outcomes
Primary Outcomes
Vaginal Vault hematoma
Time Frame: From 10 days postoperative to 30 days postoperative
It will be assessed by examination and ultrasound
Secondary Outcomes
- 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)
Investigators
Rowan Ashraf AbdelHady Sakr
Resident
Ain Shams University
Study Sites (1)
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