Study Investigating Role of Unalike Patient Positioning on PROMIS Scores

Surgery Clinical Trial

— STIRUPPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446950
• Other study ID #: 18.0061
• Status: Completed
• Phase: N/A
• Start date: March 6, 2018
• Est. completion date: May 4, 2020

Study information

• Verified date: June 2020
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: May 4, 2020
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity
• Surgery
• Vaginal Hysterectomy
• Vaginal Surgery

Intervention

Procedure:
• Vaginal Surgery
Patients will undergo elective surgery on vagina or bladder

Locations

Country	Name	City	State
United States	University of Louisville Physicians	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

Cardosi RJ, Cox CS, Hoffman MS. Postoperative neuropathies after major pelvic surgery. Obstet Gynecol. 2002 Aug;100(2):240-4. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Power H. Patient positioning outcomes for women undergoing gynaecological surgeries. Can Oper Room Nurs J. 2002 Sep;20(3):7-10, 27-30. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient-Reported Outcomes Measurement and Information System(PROMIS) Physical Function Scale	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.	preop and 6 weeks post op
Secondary	Angles of positioning	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	Intra-operative