The Effect of Uterine Manipulator Use During Abdominal Hysterectomy on Postoperative Sexual Function
ID: NCT07431788
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This prospective, single-center, randomized controlled trial aims to evaluate the effect of uterine manipulator use during total abdominal hysterectomy on postoperative female sexual function at 3 months, assessed by the Female Sexual Function Index (FSFI). Secondary outcomes include operative time, perioperative hemoglobin change, postoperative pain (VAS), hospital stay duration, and 30-day complications.
Use of a uterine manipulator during total abdominal hysterectomy.
Total abdominal hysterectomy without uterine manipulator.
Treatment Arms Description
Total abdominal hysterectomy performed using a uterine manipulator.
Conventional total abdominal hysterectomy performed without uterine manipulator.
- Women aged ≥18 years
- 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
- Gynecologic malignancy
- Major additional pelvic reconstructive surgery
- Severe psychiatric or neurologic disorder
- Inability to complete follow-up assessments
Primary Outcome Measures
- 3-Month Postoperative Female Sexual Function Index Total Score — Time Frame: Assessed at postoperative month 3 (±2 weeks)
Female Sexual Function Index (FSFI) total score measured at 3 months after surgery. The FSFI is a validated 19-item questionnaire assessing sexual function across six domains. Total scores range from 2 to 36, with higher scores indicating better sexual function.
View Secondary Outcome Measures (5)
- Operative Time — Time Frame: Measured intraoperatively from skin incision to skin closure (single assessment during surgery)
Total operative duration measured in minutes from skin incision to completion of skin closure during total abdominal hysterectomy.
- Postoperative Pain Assessed by Visual Analog Scale (VAS) — Time Frame: Assessed at 6 hours (±1 hour), 12 hours (±2 hours), and 24 hours (±2 hours) after surgery
Postoperative pain intensity measured using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain.
- Change in Hemoglobin Level — Time Frame: Assessed at 6 hours (±1 hour), 12 hours (±2 hours), and 24 hours (±2 hours) after surgery
Difference between preoperative hemoglobin level and hemoglobin level measured 24 hours after surgery to assess perioperative blood loss.
- Length of Hospital Stay — Time Frame: From the date of surgery until hospital discharge, assessed up to 30 days postoperatively
Duration of hospitalization measured in days from the date of surgery until discharge.
- Postoperative Complications Within 30 Days — Time Frame: From the date of surgery until 30 days postoperatively (complications assessed up to 30 days after surgery)
Incidence of postoperative complications occurring within 30 days after surgery, classified according to the Clavien-Dindo grading system.
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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View Official Medical/Scientific Title
A Prospective Randomized Controlled Trial Evaluating the Impact of Uterine Manipulator Use During Total Abdominal Hysterectomy on Postoperative Female Sexual Function