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

NCT ID: NCT02133768

Last Updated: 2017-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-06-30

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

Conditions

Postoperative Urinary Retention

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lundbeck Foundation

OTHER

Sponsor Role: lead

Responsible Party

Morten Homilius

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Morten Homilius

Role: PRINCIPAL_INVESTIGATOR

Department of orthopedic, Regional Hospital Holstebro

Locations

Department of Orthopedic

Holstebro, Central Jutland, Denmark

Countries

Denmark

References

Bjerregaard LS, Homilius M, Bagi P, Hansen TB, Kehlet H. Indwelling urinary catheterisation may increase risk of complications in hip and knee arthroplasty. Dan Med J. 2019 Apr;66(4):A5538.

Reference Type: DERIVED

PMID: 30910003 (View on PubMed)

Other Identifiers

Lundbeck Foundation

Identifier Type: OTHER

Identifier Source: secondary_id

Bladder cathererisation

Identifier Type: -

Identifier Source: org_study_id