NCT03446950

Study Investigating Role of Unalike Patient Positioning on PROMIS Scores

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Physical Activity
• Surgery
• Vaginal Hysterectomy
• Vaginal Surgery

Interventions

Type	Name	Description
PROCEDURE	Vaginal Surgery	Patients will undergo elective surgery on vagina or bladder

Timeline

• Start date: 2018-03-06
• Primary completion: 2019-11-22
• Completion: 2020-05-04
• First posted: 2018-02-27
• Last updated: 2020-06-09

Locations

1 site across 1 country: United States