Candy Cane vs. Boot Stirrups in Vaginal Surgery: A Randomized Control Trial
| Registry | NCT03446950, acronym STIRUPPS |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, supportive care |
| Enrollment | 155 (Actual) |
| Sponsor | University of Louisville (Other) |
| Conditions | Physical Activity, Surgery, Vaginal Hysterectomy, Vaginal Surgery |
| Interventions | Vaginal Surgery (Procedure) |
| Dates | start 2018-03-06, primary completion 2019-11-22, completion 2020-05-04, first posted 2018-02-27, last updated 2020-06-09 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Physical Activity All trials for Surgery All trials of Vaginal Surgery
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
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 (PROMISĀ®) 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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Candy Cane | Active comparator | Procedure: Vaginal Surgery | 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. |
| Boot Stirrups | Active comparator | Procedure: Vaginal Surgery | 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. |
Sex: Female, ages: 18 Years to any, 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
| Facility | City | Country | Status |
|---|---|---|---|
| University of Louisville Physicians | Louisville, Kentucky | United States |