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OpenTrials
Completed

NCT Number: NCT03446950

Study Investigating Role of Unalike Patient Positioning on PROMIS Scores

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville Physicians

Louisville, Kentucky, 40205, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal Surgery

Procedure

Patients will undergo elective surgery on vagina or bladder

Primary outcomes

  1. Change in Patient-Reported Outcomes Measurement and Information System(PROMIS) Physical Function Scale

    Time frame: 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 outcomes

  1. Angles of positioning

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

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

Acronym: STIRUPPS

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 27, 2018
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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