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

NCT ID: NCT05359926

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-09

Study Completion Date

2023-08-01

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.

Conditions

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Foley Catheterization Ambulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Early Urethral Catheter Removal

Removal of the urethral catheter in the operating room at the conclusion of surgery

Group Type EXPERIMENTAL

Experimental

Intervention Type OTHER

Early urethral foley removal after the surgery

Delayed Urethral Catheter Removal

Removal of the urethral catheter in next morning after surgery

Group Type ACTIVE_COMPARATOR

Active comparator

Intervention Type OTHER

Delayed urethral foley removal after the surgery

Interventions

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Experimental

Early urethral foley removal after the surgery

Intervention Type OTHER

Active comparator

Delayed urethral foley removal after the surgery

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Brandon Carlson, MD, MPH

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brandon Carlson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 33960687 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27927519 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28435918 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30265646 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30113686 (View on PubMed)

Other Identifiers

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STUDY00148694

Identifier Type: -

Identifier Source: org_study_id

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