Clinical trial NCT03446950: Study Investigating Role of Unalike Patient Positioning on PROMIS Scores
Official title: Candy Cane vs. Boot Stirrups in Vaginal Surgery: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Surgery
Vaginal Hysterectomy
Vaginal Surgery
Keywords: vaginal surgery
patient position
stirrups
functional status
urogynecology
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 155
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: SUPPORTIVE_CARE

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

Eligibility 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

Primary outcomes:
measure: Change in Patient-Reported Outcomes Measurement and Information System(PROMIS) Physical Function Scale
timeFrame: preop and 6 weeks post op
Secondary outcomes:
measure: Angles of positioning
timeFrame: Intra-operative
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Physicians
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Sean L Francis, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Power H. Patient positioning outcomes for women undergoing gynaecological surgeries. Can Oper Room Nurs J. 2002 Sep;20(3):7-10, 27-30.
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.
citation: Gupta A, Meriwether K, Tuller M, Sekula M, Gaskins J, Stewart JR, Hobson D, Cardenas-Trowers O, Francis S. Candy Cane Compared With Boot Stirrups in Vaginal Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2020 Aug;136(2):333-341. doi: 10.1097/AOG.0000000000003954.