Early Versus Delayed Urinary Catheter Removal After Minimally Invasive Lumbar Spine Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Foley Catheterization, Ambulation

Intervention / Treatment
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* Other: Experimental
* Other: Active comparator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Urethral Catheter Removal<br>Removal of the urethral catheter in the operating room at the conclusion of surgery | Other: Experimental<br>* Early urethral foley removal after the surgery<br>|
| Active Comparator: Delayed Urethral Catheter Removal<br>Removal of the urethral catheter in next morning after surgery | Other: Active comparator<br>* Delayed urethral foley removal after the surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulation | Time in minutes to ambulation | After the surgery, postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facility discharge | Number of subjects discharge to facility | Average postoperative day 1-3 | 
| Home discharge | Number of subjects discharge to home | Average postoperative day 1-3 | 
| Hospital length of stay | Total number of days in the hospital | 1 to 3 days | 
| Pain medication | Total dose of opioid medication in milligrams used by each subject | Hospitalization period: postoperative day 1, 2, 3 | 
| Urinary catheter reinsertion | Total number of 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 | 
| Urinary tract infection | Total number of urinary tract infection after urinary catheter removal | 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 | Maximum walking distance tolerated in meters by each subject | Hospitalization period: postoperative day 1, 2, 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumbar spine, foley catheterization, ambulation