A Prospective Randomized Controlled Trial Evaluating the Impact of Uterine Manipulator Use During Total Abdominal Hysterectomy on Postoperative Female Sexual Function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 3-Month Postoperative Female Sexual Function Index Total Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients will be blinded to group allocation. Data analysis will be performed using coded group assignments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Gynecologic malignancy
- •Major additional pelvic reconstructive surgery
- •Severe psychiatric or neurologic disorder
- •Inability to complete follow-up assessments
研究组 & 干预措施
Abdominal Hysterectomy With Uterine Manipulator
Total abdominal hysterectomy performed using a uterine manipulator.
干预措施: Uterine Manipulator (Procedure)
Abdominal Hysterectomy Without Uterine Manipulator
Conventional total abdominal hysterectomy performed without uterine manipulator.
干预措施: Conventional Abdominal Hysterectomy (Procedure)
结局指标
主要结局
3-Month Postoperative Female Sexual Function Index Total Score
时间窗: 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.
次要结局
- Operative Time(Measured intraoperatively from skin incision to skin closure (single assessment during surgery))
- Postoperative Pain Assessed by Visual Analog Scale (VAS)(Assessed at 6 hours (±1 hour), 12 hours (±2 hours), and 24 hours (±2 hours) after surgery)
- Change in Hemoglobin Level(Assessed at 6 hours (±1 hour), 12 hours (±2 hours), and 24 hours (±2 hours) after surgery)
- Length of Hospital Stay(From the date of surgery until hospital discharge, assessed up to 30 days postoperatively)
- Postoperative Complications Within 30 Days(From the date of surgery until 30 days postoperatively (complications assessed up to 30 days after surgery))
研究者
Erkan Gol
Principal Investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital