An interventional study of Uterine Manipulator and Conventional Abdominal Hysterectomy in Leiomyoma (Uterine Fibroids), Adenomyoma of Uterus and Uterine Bleeding, sponsored by Erkan Gol. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Erkan Gol · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Total abdominal hysterectomy performed using a uterine manipulator.
Procedure: Uterine Manipulator
Conventional total abdominal hysterectomy performed without uterine manipulator.
Procedure: Conventional Abdominal Hysterectomy
Use of a uterine manipulator during total abdominal hysterectomy.
Total abdominal hysterectomy without uterine manipulator.
3-Month Postoperative Female Sexual Function Index Total Score
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.
Time frame: Assessed at postoperative month 3 (±2 weeks)
Operative Time
Total operative duration measured in minutes from skin incision to completion of skin closure during total abdominal hysterectomy.
Time frame: Measured intraoperatively from skin incision to skin closure (single assessment during surgery)
Postoperative Pain Assessed by Visual Analog Scale (VAS)
Postoperative pain intensity measured using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain.
Time frame: Assessed at 6 hours (±1 hour), 12 hours (±2 hours), and 24 hours (±2 hours) after surgery
Change in Hemoglobin Level
Difference between preoperative hemoglobin level and hemoglobin level measured 24 hours after surgery to assess perioperative blood loss.
Time frame: Assessed at 6 hours (±1 hour), 12 hours (±2 hours), and 24 hours (±2 hours) after surgery
Length of Hospital Stay
Duration of hospitalization measured in days from the date of surgery until discharge.
Time frame: From the date of surgery until hospital discharge, assessed up to 30 days postoperatively
Postoperative Complications Within 30 Days
Incidence of postoperative complications occurring within 30 days after surgery, classified according to the Clavien-Dindo grading system.
Time frame: From the date of surgery until 30 days postoperatively (complications assessed up to 30 days after surgery)
Plan to share: Undecided
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Erkan Gol