Early Versus Delayed Urinary Catheter Removal After Minimally Invasive Lumbar Spine Surgery: A Randomized-Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Ambulation
Study Overview
Brief Summary
The study aims to compare between early versus delayed urinary catheter removal the impact on time to ambulation (in minutes) after minimally invasive lumbar spine surgery
Detailed Description
Early ambulation enables rapid removal of drainage tubes and canisters and decreases length of hospitalization. Previous article showed that a 1-day shorter in hospitalization led to an approximately US$ 2000 reduction in total patient costs. Another study examining patients after total knee arthroplasty found that an early discharge group, a decrease in length of stay in 22h resulted in financial savings of approximately US$ 600 per case.
Another author found that early ambulation was associated with 19% lower 90-day readmission rate. Moreover, early ambulation contributed to 50.6% lower probability of developing at least one complication than regular ambulation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 18 years and older
- •Minimally invasive one- or two-level lumbar fusion procedures
Exclusion Criteria
- •Patients that cannot give consent
- •Patients with lower extremity amputation(s);
- •Non-minimally invasive surgeries
- •Patients with pre-existing bladder/kidney or urinary tract dysfunction
- •Patients with spinal cord injuries
- •Patients with known lower extremity weakness and impaired mobility.
Outcomes
Primary Outcomes
Ambulation
Time Frame: After the surgery, postoperative day 1
Time in minutes to ambulation
Secondary Outcomes
- Home discharge(Average postoperative day 1-3)
- Pain medication(Hospitalization period: postoperative day 1, 2, 3)
- Urinary tract infection(From date of the surgery until the date of first documented event, whichever came first, assessed up to 1 month after the surgery)
- Physical therapy progression(Hospitalization period: postoperative day 1, 2, 3)
- Hospital length of stay(1 to 3 days)
- Facility discharge(Average postoperative day 1-3)
- Urinary catheter reinsertion(From date of the surgery until the date of first documented event, whichever came first, assessed up to discharge (1 to 3 days) after the surgery)
Investigators
Brandon Carlson, MD, MPH
Principal Investigator
University of Kansas Medical Center