Study Investigating Role of Unalike Patient Positioning on PROMIS Scores



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:March 6, 2018
End Date:May 2020
Contact:Ankita S Gupta, MD, MPH
Email:ankita.gupta@lousiville.edu
Phone:5025617260

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Candy Cane vs. Boot Stirrups in Vaginal Surgery: A Randomized Control Trial

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

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

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
We found this trial at
1
site
Louisville, Kentucky 40202
Phone: 502-588-7660
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Louisville, KY
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