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

University of Louisville (UOFL)

Status: Completed

Conditions: Vaginal Surgery; Physical Activity; Surgery; Vaginal Hysterectomy

Treatments: Procedure: Vaginal Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03446950

18.0061

Details and patient eligibility

About

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

Full 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

Enrollment: 155 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

155 participants in 2 patient groups

Candy Cane

Active Comparator group

Description:

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.

Treatment:

Procedure: Vaginal Surgery

Boot Stirrups

Active Comparator group

Description:

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.

Treatment:

Procedure: Vaginal Surgery