Comparative Study Between Retained and Non-retained Urinary Catheter in Total Knee Arthorplasty With Epidural Anesthesia
1 other identifier
interventional
242
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 6, 2017
CompletedFirst Submitted
Initial submission to the registry
November 9, 2017
CompletedFirst Posted
Study publicly available on registry
November 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2019
CompletedNovember 25, 2019
November 1, 2019
1.4 years
November 9, 2017
November 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
6 hours after surgery and 6 hours after remove urinary catherter
Secondary Outcomes (1)
urinary tract infection
7 days after surgery
Study Arms (2)
Retained Urinary Catheter
ACTIVE COMPARATORNon-retained Urinary Catheter
EXPERIMENTALInterventions
A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)
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.
Eligibility Criteria
You may qualify if:
- Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Navamindradhiraj University
Dusit, Bangkok, 10300, Thailand
Related Publications (1)
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.
PMID: 33180187DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Satit Thiengwittayaporn, M.D.
Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 9, 2017
First Posted
November 14, 2017
Study Start
November 6, 2017
Primary Completion
April 5, 2019
Study Completion
October 25, 2019
Last Updated
November 25, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share