Clinical trial NCT02133768: Routine Bladder Catheterisation Through Fast-track Hip and Knee Replacement - What Are the Consequences?
Official title: Routine Bladder Catheterisation Through Fast-track Hip and Knee Replacement - What Are the Consequences?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Urinary Retention
Lead sponsor: Lundbeck Foundation
Sponsor class: OTHER
First posted: 2014-05-08
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Primary outcomes:
measure: Number of patients needing re-catheterization
timeFrame: From removal of urinary catheter at first postoperative day and untill discharge from hospital
Secondary outcomes:
measure: Number of patients who did not get their urinary catheter removed on the first postoperative day
timeFrame: within the first 24 hours after surgery
measure: Number of urinary tract infections
timeFrame: within the first 30 days after surgery
measure: Number of patients developing postoperative micturition difficulties
timeFrame: From day 1 to day 30 after surgery
measure: Number of re-admission due to urological problems, including urosepsis
timeFrame: within the first 30 days after surgery
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Orthopedic
state: Midtjylland
Study officials:
affiliation: Department of orthopedic, Regional Hospital Holstebro
name: Morten Homilius
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.