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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03341819
Other study ID # COA 126/2560
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 6, 2017
Est. completion date October 25, 2019

Study information

Verified date November 2019
Source Navamindradhiraj University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 242
Est. completion date October 25, 2019
Est. primary completion date April 5, 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility 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

Study Design


Intervention

Procedure:
Total knee arthroplasty
A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)
Urinary Catheterization
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.

Locations

Country Name City State
Thailand Navamindradhiraj University Dusit Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Navamindradhiraj University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 7 days after surgery
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