NCT05359926

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 9, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

September 5, 2025

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

April 25, 2022

Last Update Submit

September 3, 2025

Conditions

Foley CatheterizationAmbulation

Keywords

lumbar spinefoley catheterizationambulation

Outcome Measures

Primary Outcomes (1)

  • Ambulation

    Time in minutes to ambulation

    After the surgery, postoperative day 1

Secondary Outcomes (7)

  • Facility discharge

    Average postoperative day 1-3

  • Home discharge

    Average postoperative day 1-3

  • Hospital length of stay

    1 to 3 days

  • Pain medication

    Hospitalization period: postoperative day 1, 2, 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

  • +2 more secondary outcomes

Study Arms (2)

Early Urethral Catheter Removal

EXPERIMENTAL

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

Other: Experimental

Delayed Urethral Catheter Removal

ACTIVE COMPARATOR

Removal of the urethral catheter in next morning after surgery

Other: Active comparator

Interventions

ExperimentalOTHER

Early urethral foley removal after the surgery

Early Urethral Catheter Removal
Active comparatorOTHER

Delayed urethral foley removal after the surgery

Delayed Urethral Catheter Removal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years and older
  • Minimally invasive one- or two-level lumbar fusion procedures

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (5)

  • 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.

    PMID: 33960687BACKGROUND

  • 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.

    PMID: 27927519BACKGROUND

  • 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.

    PMID: 28435918BACKGROUND

  • 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.

    PMID: 30265646BACKGROUND

  • 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.

    PMID: 30113686BACKGROUND

Study Officials

  • Brandon Carlson, MD, MPH

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2022

First Posted

May 4, 2022

Study Start

June 9, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

September 5, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)