STIRUPPS: Study Investigating Role of Unalike Patient Positioning on PROMIS Scores
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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:
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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.
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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 Design
Arms and Interventions
| 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
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| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 18 years
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English speaking
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Scheduled to undergo vaginal or urological surgery with University of Louisville Urogynecology physicians
Exclusion Criteria:
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Immobile or wheelchair bound
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Pre-existing neurological condition limiting physical function
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Age < 18 years
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Patient's with dementia or unable to give informed consent
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Non-English speaking
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Unwilling to follow up in 6 weeks
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Patient's undergoing laparoscopic, robotic or abdominal surgery or surgery through a combined approach
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Patients undergoing surgery under local anesthesia
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Patients who will be awake during positioning
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Louisville Physicians | Louisville | Kentucky | United States | 40205 |
Sponsors and Collaborators
- University of Louisville
Investigators
- Principal Investigator: Sean L Francis, MD, University of Louisville
Study Documents (Full-Text)
None provided.More Information
Publications
- Bohrer JC, Walters MD, Park A, Polston D, Barber MD. Pelvic nerve injury following gynecologic surgery: a prospective cohort study. Am J Obstet Gynecol. 2009 Nov;201(5):531.e1-7. doi: 10.1016/j.ajog.2009.07.023. Epub 2009 Sep 17.
- Cardosi RJ, Cox CS, Hoffman MS. Postoperative neuropathies after major pelvic surgery. Obstet Gynecol. 2002 Aug;100(2):240-4.
- Fleisch MC, Bremerich D, Schulte-Mattler W, Tannen A, Teichmann AT, Bader W, Balzer K, Renner SP, Römer T, Roth S, Schütz F, Thill M, Tinneberg H, Zarras K. The Prevention of Positioning Injuries during Gynecologic Operations. Guideline of DGGG (S1-Level, AWMF Registry No. 015/077, February 2015). Geburtshilfe Frauenheilkd. 2015 Aug;75(8):792-807.
- Gumus E, Kendirci M, Horasanli K, Tanriverdi O, Gidemez G, Miroglu C. Neurapraxic complications in operations performed in the lithotomy position. World J Urol. 2002 May;20(1):68-71.
- Litwiller JP, Wells RE Jr, Halliwill JR, Carmichael SW, Warner MA. Effect of lithotomy positions on strain of the obturator and lateral femoral cutaneous nerves. Clin Anat. 2004 Jan;17(1):45-9.
- Power H. Patient positioning outcomes for women undergoing gynaecological surgeries. Can Oper Room Nurs J. 2002 Sep;20(3):7-10, 27-30.
- Sung VW, Wohlrab KJ, Madsen A, Raker C. Patient-reported goal attainment and comprehensive functioning outcomes after surgery compared with pessary for pelvic organ prolapse. Am J Obstet Gynecol. 2016 Nov;215(5):659.e1-659.e7. doi: 10.1016/j.ajog.2016.06.013. Epub 2016 Jun 16.
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