Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-02-17 @ 10:50 PM
Study NCT ID:
NCT02133768
Status:
COMPLETED
Last Update Posted:
2017-03-07
First Post:
2014-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Routine Bladder Catheterisation Through Fast-track Hip and Knee Replacement - What Are the Consequences?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-06', 'studyFirstSubmitDate': '2014-04-08', 'studyFirstSubmitQcDate': '2014-05-06', 'lastUpdatePostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients needing re-catheterization', 'timeFrame': 'From removal of urinary catheter at first postoperative day and untill discharge from hospital', 'description': 'The need for re-catheterization will be asses on a daily basis until discharge from hospital (median 3 days from surgery)'}], 'secondaryOutcomes': [{'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', 'description': 'Assessed on a daily basis during admision and detailed telephone interview on day 30 after surgery'}, {'measure': 'Number of patients developing postoperative micturition difficulties', 'timeFrame': 'From day 1 to day 30 after surgery', 'description': 'All patients completes a questionary preoperatively (the international prostate symptom score) and the same questionary again on day 30 after surgery.'}, {'measure': 'Number of re-admission due to urological problems, including urosepsis', 'timeFrame': 'within the first 30 days after surgery', 'description': 'assessed by telephone interview on day 30 after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postoperative Urinary Retention']}, 'referencesModule': {'references': [{'pmid': '30910003', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nIt 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.\n\nHowever, 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.\n\nPurpose:\n\nTo 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\n\nEnd Points:\n\n1. The number of patients in need of re-catheterization due POUR\n2. The number of patients in which the removal of KAD was not carried out within 24 hours.\n3. The number of urinary tract infections from surgery to postoperative day (POD) 30\n4. The number of patients with new-onset urinary discomfort at POD 30 (Increase in IPSS score).\n5. The number of urological-related readmissions (including urosepsis) within POD 30'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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.\n\nThe study is conducted as a non-interventional, observational study and all participants will receive the department's standard treatment.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must meet all the following criteria to be eligible to enroll in the study:\n\n * Age \\>50 years.\n * Patients scheduled for primary THA or TKA.\n * Patients who have given verbal consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients who meet one or more of the following criteria may not be included in the study:\n\n * Patients who can not cooperate with the study.\n * Patients who do not understand or speak Danish.\n * Patients who are permanent catheter carriers or use disposable bladder catheterisation.\n * Patients on hemodialysis.\n * Urine Derivative patients.\n * Pregnancy or childbirth within 6 months.'}, 'identificationModule': {'nctId': 'NCT02133768', 'briefTitle': 'Routine Bladder Catheterisation Through Fast-track Hip and Knee Replacement - What Are the Consequences?', 'organization': {'class': 'OTHER', 'fullName': 'Lundbeck Foundation'}, 'officialTitle': 'Routine Bladder Catheterisation Through Fast-track Hip and Knee Replacement - What Are the Consequences?', 'orgStudyIdInfo': {'id': 'Bladder cathererisation'}, 'secondaryIdInfos': [{'id': 'Lundbeck Foundation', 'type': 'OTHER', 'domain': 'Lundbeck Foundation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500', 'city': 'Holstebro', 'state': 'Central Jutland', 'country': 'Denmark', 'facility': 'Department of Orthopedic', 'geoPoint': {'lat': 56.36009, 'lon': 8.61607}}], 'overallOfficials': [{'name': 'Morten Homilius', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of orthopedic, Regional Hospital Holstebro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lundbeck Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Morten Homilius', 'investigatorAffiliation': 'Lundbeck Foundation'}}}}