Candy Cane vs. Boot Stirrups in Vaginal Surgery: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Change in Patient-Reported Outcomes Measurement and Information System(PROMIS) Physical Function Scale
研究概览
简要总结
The primary objective is to assess the impact of patient positioning using the candy cane stirrups as compared to boot stirrups on physical functioning outcomes at 6 weeks post-op
详细描述
Patient positioning is an important component of vaginal surgery allowing the surgeon access to the vagina while minimizing patient discomfort and neurological injury. The data on appropriate patient positioning for gynecological vaginal surgery is limited with most providers basing the choice between candy cane and boot stirrups on personal preference. This study has the following aims:
- Aim 1: To perform a randomized controlled trial comparing candy cane stirrups to boot stirrups in patients undergoing vaginal surgery with the primary outcome of change in physical function at 6 weeks post-op as measured by the Patient-Reported Outcomes Measurement and Information System (PROMIS®) 20-Item Physical Functioning Short-Form.
- Aim 2: The investigators aim to measure the angles at the level of hip, knee and foot joints during the surgery in both the candy cane and boot stirrups to assess any association between angles and physical function
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be blinded to their intervention group. Investigators following up with participants at 6 weeks will be blinded to the group allocation of the participants
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years
- •English speaking
- •Scheduled to undergo vaginal or urological surgery with University of Louisville Urogynecology physicians
排除标准
- •Immobile or wheelchair bound
- •Pre-existing neurological condition limiting physical function
- •Age < 18 years
- •Patient's with dementia or unable to give informed consent
- •Non-English speaking
- •Unwilling to follow up in 6 weeks
- •Patient's undergoing laparoscopic, robotic or abdominal surgery or surgery through a combined approach
- •Patients undergoing surgery under local anesthesia
- •Patients who will be awake during positioning
研究组 & 干预措施
Candy Cane
Participants in this arm will be positioned with their legs in candy cane stirrups. Patients will then undergo scheduled vaginal surgery and be asked to complete PROMIS questionnaires before and after surgery.
干预措施: Vaginal Surgery (Procedure)
Boot Stirrups
Participants in this arm will have their feet placed in boot stirrups. Patients will then undergo scheduled vaginal surgery and be asked to complete PROMIS questionnaires before and after surgery.
干预措施: Vaginal Surgery (Procedure)
结局指标
主要结局
Change in Patient-Reported Outcomes Measurement and Information System(PROMIS) Physical Function Scale
时间窗: preop and 6 weeks post op
Patients will complete the 20 point Physical Function short form. The minimum score for this scale is 20 and maximum score is 100. A higher score is associated with a better physical function outcome.
次要结局
- Angles of positioning(Intra-operative)
研究者
Sean Francis
Chairperson & Assoc Professor
University of Louisville