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Trial record 33 of 3544 for:    Louisville

Study Investigating Role of Unalike Patient Positioning on PROMIS Scores (STIRUPPS)

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ClinicalTrials.gov Identifier: NCT03446950
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Sean Francis, 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

Condition or disease Intervention/treatment Phase
Physical Activity Surgery Vaginal Hysterectomy Vaginal Surgery Procedure: Vaginal Surgery Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Masking Description: 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
Primary Purpose: Supportive Care
Official Title: Candy Cane vs. Boot Stirrups in Vaginal Surgery: A Randomized Control Trial
Actual Study Start Date : March 6, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Active Comparator: 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.
Procedure: Vaginal Surgery
Patients will undergo elective surgery on vagina or bladder

Active Comparator: 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.
Procedure: Vaginal Surgery
Patients will undergo elective surgery on vagina or bladder




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female gender identity
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446950


Contacts
Contact: Ankita S Gupta, MD, MPH 5025617260 ankita.gupta@lousiville.edu

Locations
United States, Kentucky
University of Louisville Physicians Recruiting
Louisville, Kentucky, United States, 40205
Contact: Ankita Gupta, MD, MPH    502-588-7660      
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Sean L Francis, MD University of Louisville

Publications:
Responsible Party: Sean Francis, Chairperson & Assoc Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT03446950     History of Changes
Other Study ID Numbers: 18.0061
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sean Francis, University of Louisville:
vaginal surgery
patient position
stirrups
functional status
urogynecology