Routine Bladder Catheterisation Through Fast-track Hip an... | NCT02133768

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

NCT02133768

Sponsor

Lundbeck Foundation

Status

Completed

Last Update Posted

Mar 7, 2017Actual

Enrollment

800Actual

Phase

Not provided

Conditions

Postoperative Urinary Retention

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Lundbeck Foundation	Other Identifier	Lundbeck Foundation

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

May 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Apr 8, 2014

First Submission Date that Met QC Criteria

May 6, 2014

First Posted Date

May 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2017

Last Update Posted Date

Mar 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

The number of patients in need of re-catheterization due POUR
The number of patients in which the removal of KAD was not carried out within 24 hours.
The number of urinary tract infections from surgery to postoperative day (POD) 30
The number of patients with new-onset urinary discomfort at POD 30 (Increase in IPSS score).
The number of urological-related readmissions (including urosepsis) within POD 30

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

800Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	Assessed on a daily basis during admision and detailed telephone interview on day 30 after surgery

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Morten Homilius	Department of orthopedic, Regional Hospital Holstebro	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Department of Orthopedic		Holstebro	Central Jutland	7500	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30910003	Derived	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.