Study Investigating Role of Unalike Patient Positioning on PROMIS Scores

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-06

Study Completion Date

2020-05-04

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

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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

Conditions

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Physical Activity Surgery Vaginal Hysterectomy Vaginal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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

Study Groups

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Candy Cane

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.

Group Type ACTIVE_COMPARATOR

Vaginal Surgery

Intervention Type PROCEDURE

Patients will undergo elective surgery on vagina or bladder

Boot Stirrups

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.

Group Type ACTIVE_COMPARATOR

Vaginal Surgery

Intervention Type PROCEDURE

Patients will undergo elective surgery on vagina or bladder

Interventions

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Vaginal Surgery

Patients will undergo elective surgery on vagina or bladder

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes