Study Investigating Role of Unalike Patient Positioning on PROMIS Scores

University of Louisville155 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

155

Conditions

Physical Activity Surgery Vaginal Hysterectomy Vaginal Surgery

Interventions

Vaginal SurgeryPROCEDURE

Patients will undergo elective surgery on vagina or bladder

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Louisville Physicians

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

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.

Time frame: preop and 6 weeks post op

Secondary Outcomes

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

Time frame: Intra-operative

Data from ClinicalTrials.gov

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