Study Investigating Role of Unalike Patient Positioning on PROMIS Scores

Not Applicable

Completed

• Conditions: Physical Activity; Vaginal Surgery; Vaginal Hysterectomy; Surgery
• Interventions: Procedure: Vaginal Surgery

• Registration Number: NCT03446950
• Lead Sponsor: University of Louisville

Brief 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

Study Timeline

• Study First Submitted: 2018-02-11
• Study First Submitted QC: 2018-02-23
• Study First Posted: 2018-02-27
• Study Start: 2018-03-06
• Primary Completion: 2019-11-22
• Study Completion: 2020-05-04
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-07
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 155

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Boot Stirrups	Vaginal Surgery	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.
Candy Cane	Vaginal Surgery	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.

Primary Outcome Measures

Name	Time	Method
Change in Patient-Reported Outcomes Measurement and Information System(PROMIS) Physical Function Scale	preop and 6 weeks post op	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.

Secondary Outcome Measures

Name	Time	Method
Angles of positioning	Intra-operative	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

Trial Locations

Locations (1)

University of Louisville Physicians; 🇺🇸 Louisville, Kentucky, United States