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

Not Applicable

Recruiting

• Conditions: Foley Catheterization; Ambulation
• Interventions: Other: Experimental; Other: Active comparator

• Registration Number: NCT05359926
• Lead Sponsor: University of Kansas Medical Center

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 Timeline

• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-05-04
• Study Start: 2022-06-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Primary Completion: 2025-08
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Urethral Catheter Removal	Experimental	Removal of the urethral catheter in the operating room at the conclusion of surgery
Delayed Urethral Catheter Removal	Active comparator	Removal of the urethral catheter in next morning after surgery

Primary Outcome Measures

Name	Time	Method
Ambulation	After the surgery, postoperative day 1	Time in minutes to ambulation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States