Comparative Study Between Retained and Non-retained Urinary Catheter in Total Knee Arthorplasty With Epidural Anesthesia
Primary Purpose
Postoperative Urinary Retention, Urinary Tract Infections, Epidural Anesthesia
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Total knee arthroplasty
Urinary Catheterization
Sponsored by
About this trial
This is an interventional other trial for Postoperative Urinary Retention
Eligibility Criteria
Inclusion Criteria:
- Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty
Exclusion Criteria:
- History of renal disease
- History of urinary tract infection
- History of previous urinary tract surgery
- Benign prostatic hypertrophy
- Bilateral total knee arthroplasty
- Revision total knee arthroplasty
- Patients who need intraoperative monitoring of urine output
Sites / Locations
- Navamindradhiraj University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Retained Urinary Catheter
Non-retained Urinary Catheter
Arm Description
Outcomes
Primary Outcome Measures
postoperative urinary retention
Patients who didn't void within 6 hours with suprapubic discomfort and had a urinary volume 400 mL or more confirmed by single intermittent catheterization
Secondary Outcome Measures
urinary tract infection
An infection of the kidney, ureter, bladder, or urethra. The symptoms are burning with urination and having to urinate frequently and fever > 38° C. Urine culture shows a bacterial colony count of greater than or equal to ten to the fifth colony-forming units per mL of a typical urinary tract organism.
Full Information
NCT ID
NCT03341819
First Posted
November 9, 2017
Last Updated
November 22, 2019
Sponsor
Navamindradhiraj University
1. Study Identification
Unique Protocol Identification Number
NCT03341819
Brief Title
Comparative Study Between Retained and Non-retained Urinary Catheter in Total Knee Arthorplasty With Epidural Anesthesia
Official Title
Comparative Study Between Retained and Non-retained Urinary Catheter in Total Knee Arthorplasty With Epidural Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
October 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Navamindradhiraj University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the prevalence of postoperative urinary retention between retained and non-retained urinary catheter in total knee arthorplasty with epidural anesthesia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Urinary Retention, Urinary Tract Infections, Epidural Anesthesia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Retained Urinary Catheter
Arm Type
Active Comparator
Arm Title
Non-retained Urinary Catheter
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Total knee arthroplasty
Intervention Description
A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)
Intervention Type
Procedure
Intervention Name(s)
Urinary Catheterization
Intervention Description
Urinary catheterization is a latex, polyurethane, or silicone tube known as a urinary catheter is inserted into a patient's bladder via the urethra. Catheterization allows the patient's urine to drain freely from the bladder for collection.
Primary Outcome Measure Information:
Title
postoperative urinary retention
Description
Patients who didn't void within 6 hours with suprapubic discomfort and had a urinary volume 400 mL or more confirmed by single intermittent catheterization
Time Frame
6 hours after surgery and 6 hours after remove urinary catherter
Secondary Outcome Measure Information:
Title
urinary tract infection
Description
An infection of the kidney, ureter, bladder, or urethra. The symptoms are burning with urination and having to urinate frequently and fever > 38° C. Urine culture shows a bacterial colony count of greater than or equal to ten to the fifth colony-forming units per mL of a typical urinary tract organism.
Time Frame
7 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty
Exclusion Criteria:
History of renal disease
History of urinary tract infection
History of previous urinary tract surgery
Benign prostatic hypertrophy
Bilateral total knee arthroplasty
Revision total knee arthroplasty
Patients who need intraoperative monitoring of urine output
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satit Thiengwittayaporn, M.D.
Organizational Affiliation
Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Navamindradhiraj University
City
Dusit
State/Province
Bangkok
ZIP/Postal Code
10300
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33180187
Citation
Thiengwittayaporn S, Uthaitas P, Hongku N, Tunyasuwanakul R, Limphunudom P, Leelachiewchankul F. Indwelling urinary catheterization was unnecessary in non-drainage total knee arthroplasty: a randomized controlled trial. Arch Orthop Trauma Surg. 2021 Mar;141(3):469-476. doi: 10.1007/s00402-020-03677-z. Epub 2020 Nov 12.
Results Reference
derived
Learn more about this trial
Comparative Study Between Retained and Non-retained Urinary Catheter in Total Knee Arthorplasty With Epidural Anesthesia
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