Skip to main content
Clinical Trials/NCT05359926
NCT05359926
Withdrawn
Not Applicable

Early Versus Delayed Urinary Catheter Removal After Minimally Invasive Lumbar Spine Surgery: A Randomized-Controlled Clinical Trial

University of Kansas Medical Center1 site in 1 country80 target enrollmentJune 9, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Foley Catheterization
Sponsor
University of Kansas Medical Center
Enrollment
80
Locations
1
Primary Endpoint
Ambulation
Status
Withdrawn
Last Updated
7 months ago

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.

Registry
clinicaltrials.gov
Start Date
June 9, 2022
End Date
August 1, 2023
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brandon Carlson, MD, MPH

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

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)

Study Sites (1)

Loading locations...

Similar Trials