Actively Recruiting
Laparoscopic Versus Transvaginal Closure of the Vaginal Vault After Total Laparoscopic Hysterectomy - a Single Blinded Randomized Comparative Study
Led by Ain Shams University · Updated on 2025-03-10
48
Participants Needed
1
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two methods of closing the vaginal vault after a total laparoscopic hysterectomy (TLH), which is a procedure to remove the uterus and cervix using a laparoscope. The study focuses on adult women undergoing TLH for benign uterine conditions and aims to assess the risks of vaginal vault hematoma and other complications such as vaginal cuff infection and sexual dysfunction. This single-blinded, randomized trial is sponsored by Ain Shams University. Participants will be randomly assigned to one of two groups. One group will have the vaginal vault closed using vaginal suturing after the uterus is removed, while the other group will have the closure done laparoscopically. Both approaches are being evaluated to see which method may lead to fewer complications after surgery. During the study, participants will be monitored for vaginal vault hematoma, bleeding or spotting, vaginal infection, vaginal prolapse, vaginal cuff granulation from 10 to 30 days post-surgery, and sexual dysfunction from 3 to 4 months post-surgery. These outcomes will help determine the safety and effects of each closure technique. The study does not specify a total duration but includes follow-up assessments within the first few months after surgery.
CONDITIONS
Brief Title
Laparoscopic Versus Transvaginal Closure of the Vaginal Vault After Total Laparoscopic Hysterectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult females consenting to have total laparoscopic hysterectomy for benign uterine conditions
- Non-obese women with a body mass index (BMI) between 18 and 29.9
- Sexually active females
You will not qualify if you...
- Diagnosed pelvic malignancy
- Cervical intraepithelial neoplasia or bacterial vaginosis (infections must be treated before participation)
- Obese patients
- Current treatment for any type of cancer
- Coagulopathy or bleeding/clotting disorders
- Conditions impairing wound healing such as diabetes mellitus, anemia, or steroid use
- Previous radiation treatment or allergy to sutures
- Clinically evident vaginal prolapse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus immediate recovery period
Participants undergo total laparoscopic hysterectomy followed by closure of the vaginal vault using either a vaginal or laparoscopic suturing approach.
1 surgical visit (in-person)
Duration - 20 days
Participants are monitored for complications such as vaginal vault hematoma, bleeding, infection, prolapse, and granulation from 10 to 30 days after surgery.
Visits between 10 and 30 days post-operative (number of visits may vary)
Duration - 1 month
Participants are assessed for sexual dysfunction and other long-term outcomes from 3 to 4 months after surgery.
1 to 2 visits between 3 and 4 months post-operative
Trial Site Locations
Total: 1 location
1
Ain Shams University maternity hospital
Cairo, Egypt
Actively Recruiting
Research Team
R
Rowan A Sakr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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