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

Ambulation Clinical Trial

— EDUCaRe  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05359926
• Other study ID #: STUDY00148694
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: August 2024

Study information

• Verified date: April 2022
• Source: University of Kansas Medical Center
• Contact: Costa
• Phone: 913-326-5561
• Email: mcosta[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ambulation
• Foley Catheterization

Intervention

Other:
• Experimental
Early urethral foley removal after the surgery
• Active comparator
Delayed urethral foley removal after the surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulation	Time in minutes to ambulation	After the surgery, postoperative day 1
Secondary	Facility discharge	Number of subjects discharge to facility	Average postoperative day 1-3
Secondary	Home discharge	Number of subjects discharge to home	Average postoperative day 1-3
Secondary	Hospital length of stay	Total number of days in the hospital	1 to 3 days
Secondary	Pain medication	Total dose of opioid medication in milligrams used by each subject	Hospitalization period: postoperative day 1, 2, 3
Secondary	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
Secondary	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
Secondary	Physical therapy progression	Maximum walking distance tolerated in meters by each subject	Hospitalization period: postoperative day 1, 2, 3