Candy Cane vs. Boot Stirrups in Vaginal Surgery: A Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Louisville
- Enrollment
- 155
- Locations
- 2
- Primary Endpoint
- Change in Patient-Reported Outcomes Measurement and Information System(PROMIS) Physical Function Scale
Study Overview
Brief Summary
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
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
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
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age > 18 years
- •English speaking
- •Scheduled to undergo vaginal or urological surgery with University of Louisville Urogynecology physicians
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in Patient-Reported Outcomes Measurement and Information System(PROMIS) Physical Function Scale
Time Frame: 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.
Secondary Outcomes
- Angles of positioning(Intra-operative)
Investigators
Sean Francis
Chairperson & Assoc Professor
University of Louisville