NCT05518175已完成不适用
Patient-centered Outcomes After Permanent Female Sterilization Procedure: A Randomized Controlled Trial Comparing Three Surgical Routes
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2022年11月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Quality of recovery after surgery as assessed by the Quality of Recovery (QOR-40 )questionnaire
研究概览
简要总结
The purpose of this study is to compare and capture key elements of the patient experience, quality of recovery, preferences and satisfaction after laparoscopic salpingectomy done via 3 different routes.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women scheduled to undergo an elective sterilization surgery regardless of parity
- •non-prolapsed uterus
- •Patients should able to provide written consent
排除标准
- •Women who have relative contra-indication to vaginal peritoneal access such as: history of rectal surgery, suspected recto-vaginal endometriosis based on clinical history and examination, suspected malignancy, pelvic inflammatory disease, active lower genital tract infection, virginity or pregnancy
- •Postpartum (immediate) tubal sterilization
- •Tubal sterilization during a cesarean section
研究组 & 干预措施
Route A: Traditional laparoscopy
Active Comparator
干预措施: Traditional laparoscopy (Procedure)
Route B: Single site laparoscopy
Experimental
干预措施: Single site laparoscopy (Procedure)
Route C:V-Notes surgery
Experimental
干预措施: V-Notes surgery (Procedure)
结局指标
主要结局
Quality of recovery after surgery as assessed by the Quality of Recovery (QOR-40 )questionnaire
时间窗: 24 hours after surgery
This questionnaire has 40 questions, score varies from 40 (poor)-200 (excellent) a higher number indicating a better outcome
次要结局
- Patient satisfaction as assessed by the satisfaction scale(3 months post surgery)
- Pain as assessed by the Resting Visual Analog Scale (VAS)(3 months post surgery)
- Cosmesis as assessed by the Body Image Questionnaire(3 months post surgery)
- Change in sexual function as assessed by the Short version of the Female Sexual Function Index (FSFI)(Baseline, 3 months post surgery)
- Pain as assessed by the Dynamic Visual Analog Scale (VAS)(3 months post surgery)
- Cosmesis as assessed by the Body Image Questionnaire(2 weeks post surgery)
- Cosmesis as assessed by the Body Image Questionnaire(6 weeks post surgery)
- Pain as assessed by the Resting Visual Analog Scale (VAS)(24 hours post surgery)
- Pain as assessed by the Resting Visual Analog Scale (VAS)(2 weeks post surgery)
- Pain as assessed by the Resting Visual Analog Scale (VAS)(6 weeks post surgery)
研究者
Randa Jalloul
Associate Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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