Comparative Study Between Retained and Non-retained Urinary Catheter in Total Knee Arthorplasty With Epidural Anesthesia

NCT ID: NCT03341819

Last Updated: 2019-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-06

Study Completion Date

2019-10-25

Brief Summary

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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

Detailed Description

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Conditions

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Postoperative Urinary Retention Urinary Tract Infections Epidural Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Retained Urinary Catheter

Group Type ACTIVE_COMPARATOR

Total knee arthroplasty

Intervention Type PROCEDURE

A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)

Urinary Catheterization

Intervention Type PROCEDURE

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.

Non-retained Urinary Catheter

Group Type EXPERIMENTAL

Total knee arthroplasty

Intervention Type PROCEDURE

A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)

Interventions

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Total knee arthroplasty

A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Navamindradhiraj University

OTHER

Sponsor Role lead

Responsible Party

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Satit Thiengwittayaporn

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Satit Thiengwittayaporn, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University

Locations

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Navamindradhiraj University

Dusit, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type DERIVED
PMID: 33180187 (View on PubMed)

Other Identifiers

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COA 126/2560

Identifier Type: -

Identifier Source: org_study_id

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