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Clinical Trials/NCT02133768
NCT02133768
Completed
Not Applicable

Routine Bladder Catheterisation Through Fast-track Hip and Knee Replacement - What Are the Consequences?

Lundbeck Foundation1 site in 1 country800 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Urinary Retention
Sponsor
Lundbeck Foundation
Enrollment
800
Locations
1
Primary Endpoint
Number of patients needing re-catheterization
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

To describe the need for re-catheterization and incidence of urological complications of routine use of perioperative fixed urinary catheter (KAD) for up to 24 hours of fast-track THA and TKA

Detailed Description

Postoperative urinary retention (POUR) is a well known complication of fast-track total hip (THA) and knee arthroplasty (TKA), and even though medical options have been attempted, bladder catheterisation remains the only well-documented capacity to prevent and / or treat POUR. It was previously standard to use fixed urinary catheter (KAD), the first 24-48 hours postoperatively to prevent POUR by THA and TKA, while more recent studies now recommend intermittent urinary catheterization in the postoperative period. However, there are no detailed studies with adequate follow-up, describing the consequences of using either one or the other treatment regimen of POUR by fast-track THA and TKA. Purpose: To describe the need for re-catheterization and incidence of urological complications of routine use of perioperative fixed urinary catheter (KAD,catheter a demure) for up to 24 hours of fast-track THA and TKA End Points: 1. The number of patients in need of re-catheterization due POUR 2. The number of patients in which the removal of KAD was not carried out within 24 hours. 3. The number of urinary tract infections from surgery to postoperative day (POD) 30 4. The number of patients with new-onset urinary discomfort at POD 30 (Increase in IPSS score). 5. The number of urological-related readmissions (including urosepsis) within POD 30

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
June 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Lundbeck Foundation
Responsible Party
Principal Investigator
Principal Investigator

Morten Homilius

MD

Lundbeck Foundation

Eligibility Criteria

Inclusion Criteria

  • Patients must meet all the following criteria to be eligible to enroll in the study:
  • Age \>50 years.
  • Patients scheduled for primary THA or TKA.
  • Patients who have given verbal consent to participate in the study.

Exclusion Criteria

  • Patients who meet one or more of the following criteria may not be included in the study:
  • Patients who can not cooperate with the study.
  • Patients who do not understand or speak Danish.
  • Patients who are permanent catheter carriers or use disposable bladder catheterisation.
  • Patients on hemodialysis.
  • Urine Derivative patients.
  • Pregnancy or childbirth within 6 months.

Outcomes

Primary Outcomes

Number of patients needing re-catheterization

Time Frame: From removal of urinary catheter at first postoperative day and untill discharge from hospital

The need for re-catheterization will be asses on a daily basis until discharge from hospital (median 3 days from surgery)

Secondary Outcomes

  • Number of patients who did not get their urinary catheter removed on the first postoperative day(within the first 24 hours after surgery)
  • Number of urinary tract infections(within the first 30 days after surgery)
  • Number of patients developing postoperative micturition difficulties(From day 1 to day 30 after surgery)
  • Number of re-admission due to urological problems, including urosepsis(within the first 30 days after surgery)

Study Sites (1)

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