Clinical trial NCT05359926: Early Versus Delayed Urinary Catheter Removal After Minimally Invasive Lumbar Spine Surgery
Official title: Early Versus Delayed Urinary Catheter Removal After Minimally Invasive Lumbar Spine Surgery: a Randomized-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Foley Catheterization
Ambulation
Keywords: lumbar spine
foley catheterization
ambulation
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Ambulation
timeFrame: After the surgery, postoperative day 1
Secondary outcomes:
measure: Facility discharge
timeFrame: Average postoperative day 1-3
measure: Home discharge
timeFrame: Average postoperative day 1-3
measure: Hospital length of stay
timeFrame: 1 to 3 days
measure: Pain medication
timeFrame: Hospitalization period: postoperative day 1, 2, 3
measure: Urinary catheter reinsertion
timeFrame: 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
measure: Urinary tract infection
timeFrame: From date of the surgery until the date of first documented event, whichever came first, assessed up to 1 month after the surgery
measure: Physical therapy progression
timeFrame: Hospitalization period: postoperative day 1, 2, 3
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Brandon Carlson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang J, Shi Z, Duan FF, Fan MX, Yan S, Wei Y, Han B, Lu XM, Tian W. Benefits of Early Ambulation in Elderly Patients Undergoing Lumbar Decompression and Fusion Surgery: A Prospective Cohort Study. Orthop Surg. 2021 Jun;13(4):1319-1326. doi: 10.1111/os.12953. Epub 2021 May 7.
citation: Gornitzky AL, Flynn JM, Muhly WT, Sankar WN. A Rapid Recovery Pathway for Adolescent Idiopathic Scoliosis That Improves Pain Control and Reduces Time to Inpatient Recovery After Posterior Spinal Fusion. Spine Deform. 2016 Jul;4(4):288-295. doi: 10.1016/j.jspd.2016.01.001. Epub 2016 Jun 16.
citation: Raudenbush BL, Gurd DP, Goodwin RC, Kuivila TE, Ballock RT. Cost analysis of adolescent idiopathic scoliosis surgery: early discharge decreases hospital costs much less than intraoperative variables under the control of the surgeon. J Spine Surg. 2017 Mar;3(1):50-57. doi: 10.21037/jss.2017.03.11.
citation: Marsh J, Somerville L, Howard JL, Lanting BA. Significant cost savings and similar patient outcomes associated with early discharge following total knee arthroplasty. Can J Surg. 2019 Feb 1;62(1):20-24. doi: 10.1503/cjs.002118.
citation: Park P, Nerenz DR, Aleem IS, Schultz LR, Bazydlo M, Xiao S, Zakaria HM, Schwalb JM, Abdulhak MM, Oppenlander ME, Chang VW. Risk Factors Associated With 90-Day Readmissions After Degenerative Lumbar Fusion: An Examination of the Michigan Spine Surgery Improvement Collaborative (MSSIC) Registry. Neurosurgery. 2019 Sep 1;85(3):402-408. doi: 10.1093/neuros/nyy358.