Study Investigating Role of Unalike Patient Positioning on PROMIS Scores

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Physical Activity, Surgery, Vaginal Hysterectomy, Vaginal Surgery

Intervention / Treatment
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* Procedure: Vaginal Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: To compare patient positioning during vaginal surgery we plan to conduct a single site single blinded randomized controlled trial where patients planning elective vaginal surgery will be randomized to be positioned in Candy cane or Boot stirrups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Candy Cane<br>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. | Procedure: Vaginal Surgery<br>* Patients will undergo elective surgery on vagina or bladder<br>|
| Active Comparator: Boot Stirrups<br>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. | Procedure: Vaginal Surgery<br>* Patients will undergo elective surgery on vagina or bladder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient-Reported Outcomes Measurement and Information System(PROMIS) Physical Function Scale | 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. | preop and 6 weeks post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angles of positioning | 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 | Intra-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal surgery, patient position, stirrups, functional status, urogynecology