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

NCT02133768 | Completed

• 2 other identifiers: Bladder cathererisationLundbeck Foundation
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Urinary Retention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participating patients may help to clarify the consequences of using fixed bladder catheterisation of patients undergoing planned deployment of an artificial hip or knee. This will provide a basis to compare the effects of these practices with other treatment regimens, such as. intermittent once-bladder catheterisation in the postoperative period, which may contribute to the prevention and treatment of POUR can be optimized for all patients. The study is conducted as a non-interventional, observational study and all participants will receive the department's standard treatment.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lundbeck Foundation: lead

Study Sites (1)

Department of Orthopedic

Holstebro, Central Jutland, 7500, Denmark

Location

Related Publications (1)

• 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.

  PMID: 30910003 DERIVED

Study Officials

• Morten Homilius

  Department of orthopedic, Regional Hospital Holstebro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: May 8, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 7, 2017

Record last verified: 2017-03

Locations

DK (1)