Clinical trial NCT02126813: When to Perform Bladder Catheterization in Fast-track Hip and Knee Arthroplasty
Official title: Urinary Bladder Catheterization in Fast-track Hip and Knee Arthroplasty - What is the Optimal Bladder Volume? A Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Urinary Retention (POUR)
Keywords: Postoperative urinary retention
Fast-track total hip (THA) and knee arthroplasty (TKA)
Urinary bladder volume
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2014-04-30
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 125
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Approximately 40 % of all patients undergoing fast-track total hip or knee arthroplasty needs intermittent bladder catheterization after surgery, as they are transient incapable of voluntary bladder emptying (postoperative urinary retention - POUR). The currently used interventional threshold for urinary bladder catheterization are a bladder volume of approximately 500 ml., but no evidence exists for this threshold. At the same time, the current knowledge suggest, that a bladder volume up to 1000 ml. for 2-4 hours are safe in humans, and as the use of urinary bladder catheterization are increasing the risk of complications, the investigators are hypothesizing that increasing the interventional threshold for urinary bladder catheterization after fast-track total hip or knee arthroplasty, will reduce the number of patients needing urinary bladder catheterization, without increasing the incidence of urological complications - including urinary tract infections.


Eligibility criteria: Inclusion Criteria:

* planned for elective total hip or knee arthroplasty
* given written informed consent for participation

Exclusion Criteria:

* can't co-operate to participation
* can't speak or understand danish
* preoperative use of urinary bladder catheterization
* using haemodialysis
* previous cystectomy
* need for permanent urinary bladder catheter during surgery (decided by anaesthesiologist and/or surgeon)
* Pregnant or given birth within the last 6 months

Primary outcomes:
measure: Number of patients receiving postoperative urinary bladder catheterization
timeFrame: Patients will be followed from end of surgery to their first voluntary micturition, expectably within a mean period of twelve hours
Secondary outcomes:
measure: Incidence of urinary tract infections
timeFrame: within the first 30 days after surgery
measure: Number of voiding difficulties acquired postoperatively
timeFrame: within the first 30 days postoperatively
measure: Number of readmissions due to urological issues (including urosepsis)
timeFrame: Within the first 30 days postoperatively
Other outcomes:
measure: Time from last preoperative micturition to end of surgery.
timeFrame: Patients will be follwed from their last preoperative micturition to end of surgery. Expectably within a mean period of two hours.
measure: Time from last preoperative micturitions to first postoperative bladder catheterization (if relevant).
timeFrame: Patients will be follwed from their last preoperative micturition to their first postoperative bladder catheterization (if relevant). Expectably within a mean period of six to eight hours.
measure: Time from last preoperative micturition to first postoperative, voluntary micturition.
timeFrame: Patients will be follwed from their last preoperative micturition to their first postoperative, voluntary micturition. Expectably within a mean period of fourteen hours.
measure: Time from end of surgery to first postoperative bladder catheterization (if relevant).
timeFrame: Patients will be follwed from end of surgery to their first postoperative bladder catheterization (if relevant). Expectably within a mean period of four to six hours.
measure: Time from end of surgery to first postoperative, voluntary micturition.
timeFrame: Patient will be followed from end of surgery to their first postoperative, voluntary micturition. Expectably within a mean period of twelve hours.
Locations:
city: Farsoe
country: Denmark
facility: Aalborg University Hospital, Farsoe
city: Hellerup
country: Denmark
facility: Department of Orthopaedics, Gentofte University Hospital
city: Vejle
country: Denmark
facility: Department of Orthopaedics, Vejle Hospital
Study officials:
affiliation: Rigshospitalet, Copenhagen university, Denmark
name: Lars Bjerregaard, MD
role: PRINCIPAL_INVESTIGATOR
References: