Actively Recruiting
A Prospective Randomized Controlled Trial Evaluating the Impact of Uterine Manipulator Use During Total Abdominal Hysterectomy on Postoperative Female Sexual Function
Led by Erkan Gol · Updated on 2026-03-03
60
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are conducting a prospective, single-center, randomized controlled trial to assess how using a uterine manipulator during total abdominal hysterectomy affects female sexual function three months after surgery. The study focuses on women undergoing hysterectomy for benign conditions such as uterine fibroids, adenomyoma, or uterine bleeding. The main goal is to measure postoperative sexual function using the Female Sexual Function Index (FSFI). Participants are randomly assigned to one of two groups: one group undergoes total abdominal hysterectomy with a uterine manipulator, and the other group undergoes the same surgery without the manipulator. Both procedures are performed under double masking to reduce bias. The trial also examines secondary outcomes including operative time, changes in hemoglobin levels, postoperative pain at several time points, length of hospital stay, and complications occurring within 30 days after surgery. During the study, participants will complete the FSFI questionnaire three months after surgery to assess sexual function. Researchers will monitor operative details during surgery and assess pain levels using a visual analog scale at 6, 12, and 24 hours postoperatively. Hemoglobin levels will be measured at similar time points. Hospital stay duration and any complications within 30 days after surgery will be recorded. The entire participation focuses on these assessments to evaluate the impact of the uterine manipulator on recovery and sexual health.
CONDITIONS
Brief Title
The Effect of Uterine Manipulator Use During Abdominal Hysterectomy on Postoperative Sexual Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 218 years or older
- Planned total abdominal hysterectomy for benign indications
- Sexually active within the last 4 weeks
- Able to complete the Female Sexual Function Index (FSFI) questionnaire
- Provided written informed consent
You will not qualify if you...
- Gynecologic malignancy
- Major additional pelvic reconstructive surgery
- Severe psychiatric or neurologic disorder
- Inability to complete follow-up assessments
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 - 1 day
Participants undergo total abdominal hysterectomy either with or without the use of a uterine manipulator, followed by immediate post-operative assessments.
1 surgery visit and assessments up to 24 hours after surgery
Duration - Up to 30 days
Participants are monitored for postoperative pain, hemoglobin levels, complications, and length of hospital stay up to 30 days after surgery.
Assessments at 6, 12, and 24 hours after surgery plus hospital stay monitoring
Duration - Approximately 3 months
Participants complete the Female Sexual Function Index questionnaire to assess postoperative sexual function approximately 3 months after surgery.
1 follow-up visit (in-person or remote) around postoperative month 3 (±2 weeks)
Trial Site Locations
Total: 1 location
1
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Istanbul, Turkey (Türkiye), 34147
Actively Recruiting
Research Team
E
Erkan Göl, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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