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

Postoperative Urinary Retention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133768
• Other study ID #: Bladder cathererisation
• Secondary ID: Lundbeck Foundat
• Status: Completed
• Phase: N/A
• First received: April 8, 2014
• Last updated: March 6, 2017
• Start date: May 2014
• Est. completion date: June 2016

Study information

• Verified date: March 2017
• Source: Lundbeck Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Urinary Retention
• Urinary Retention

Locations

Country	Name	City	State
Denmark	Department of Orthopedic	Holstebro	Midtjylland

Sponsors (1)

Lead Sponsor	Collaborator
Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients needing re-catheterization	The need for re-catheterization will be asses on a daily basis until discharge from hospital (median 3 days from surgery)	From removal of urinary catheter at first postoperative day and untill discharge from hospital
Secondary	Number of patients who did not get their urinary catheter removed on the first postoperative day		within the first 24 hours after surgery
Secondary	Number of urinary tract infections	Assessed on a daily basis during admision and detailed telephone interview on day 30 after surgery	within the first 30 days after surgery
Secondary	Number of patients developing postoperative micturition difficulties	All patients completes a questionary preoperatively (the international prostate symptom score) and the same questionary again on day 30 after surgery.	From day 1 to day 30 after surgery
Secondary	Number of re-admission due to urological problems, including urosepsis	assessed by telephone interview on day 30 after surgery	within the first 30 days after surgery