Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-26 @ 11:26 AM
Study NCT ID:
NCT05249192
Status:
COMPLETED
Last Update Posted:
2024-11-29
First Post:
2022-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'patients and surgeons are blinded to group allocation until the end of surgical procedure'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, randomized, controlled, two-arm, multi-center trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2022-02-09', 'studyFirstSubmitQcDate': '2022-02-18', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute urinary retention rate', 'timeFrame': '3 days postoperatively', 'description': 'Occurrence of urinary retention after removal of urinary catheter'}], 'secondaryOutcomes': [{'measure': 'Urinary tract infections', 'timeFrame': '30 days postoperatively', 'description': 'Occurrence of urinary tract infections'}, {'measure': 'UC reinsertion', 'timeFrame': '30 days postoperatively', 'description': 'need for urinary catheter reinsertion after first removal'}, {'measure': 'Pain scores', 'timeFrame': '6,12,24,48 and 72 hours after surgery', 'description': 'Numeric Rating Scores (NRS) for abdominal pain (0-10)'}, {'measure': 'Bowel function', 'timeFrame': '10 days postoperatively', 'description': 'Time for return of bowel function as for flatus and stools postoperatively'}, {'measure': 'Mobilization', 'timeFrame': '10 days postoperatively', 'description': 'Return to passive and active mobilization postoperatively'}, {'measure': 'Morbility', 'timeFrame': 'first 30 days after surgery', 'description': 'Postoperative morbility according to the Clavien-Dindo classification'}, {'measure': 'Length of hospital stay', 'timeFrame': '30 days postoperatively', 'description': 'postoperative stay'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Complication', 'Colonic Disease', 'Postoperative Complications', 'Urinary Retention Postoperative', 'Urinary Tract Infections']}, 'referencesModule': {'references': [{'pmid': '36414969', 'type': 'DERIVED', 'citation': 'Pedrazzani C, Montroni I, Conti C, Turri G, Foppa C, Carvello M, Taffurelli G, Ugolini G, Spinelli A. Immediate versus early (24-hours) urinary catheter removal after elective minimally invasive colonic resection: study protocol for a randomized, multicenter, non-inferiority trial. Trials. 2022 Nov 22;23(1):956. doi: 10.1186/s13063-022-06894-6.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to compare the rate of acute urinary retention (AUR) after immediate compared to early (24-hours) removal of urinary catheter (UC) in patients undergoing minimally invasive colorectal resection. The study hypothesis is that immediate UC removal is non-inferior to 24-hours UC removal in terms of AUR rate.\n\nThe secondary outcomes focus on goals that could be positively impacted by the immediate removal of the UC at the end of the surgery. In particular, the rate of urinary tract infections, perception of pain, time-to-return of bowel and physical functions, postoperative complications and postoperative length of stay will all be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 years and 80 years old\n2. Patients scheduled to undergo minimally invasive resection of the colon under general anesthesia\n3. Willingness to participate\n4. Compliance to study purpose\n5. Written informed consent\n\nExclusion Criteria:\n\n1. Need for an anastomosis below the anterior peritoneal reflection\n2. Need for a major resection other than colorectal\n3. Need for post-operative intensive care monitoring or intensive care unit (ICU) stay\n4. Anesthesia time longer than 300 minutes\n5. Presence of chronic indwelling UC\n6. Presence of an entero-vesical fistula\n7. Need for ureteral stent placement, bladder resection or repair\n8. A previous and unsolved history of AUR or overt voiding dysfunction'}, 'identificationModule': {'nctId': 'NCT05249192', 'briefTitle': 'Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera Universitaria Integrata Verona'}, 'officialTitle': 'Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection: Study Protocol for a Randomized, Multicenter, Non-inferiority Trial', 'orgStudyIdInfo': {'id': 'EURiCaRe'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate UC removal', 'description': 'Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room.', 'interventionNames': ['Device: Immediate urinary catheter removal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Early UC removal', 'description': 'Urinary catheter removal on first postoperative day (6 a.m.) as per standard protocol', 'interventionNames': ['Device: Early urinary catheter removal']}], 'interventions': [{'name': 'Immediate urinary catheter removal', 'type': 'DEVICE', 'description': 'Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room.', 'armGroupLabels': ['Immediate UC removal']}, {'name': 'Early urinary catheter removal', 'type': 'DEVICE', 'description': 'urinary catheter removal on the first postoperative day (6 a.m)', 'armGroupLabels': ['Early UC removal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37134', 'city': 'Verona', 'state': 'Italy', 'country': 'Italy', 'facility': 'Division of General and Hepatobiliary Surgery', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'overallOfficials': [{'name': 'Corrado Pedrazzani, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universita di Verona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera Universitaria Integrata Verona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Faenza Hospital', 'class': 'UNKNOWN'}, {'name': 'Ravenna Hospital', 'class': 'UNKNOWN'}, {'name': 'Humanitas Research Hospital IRCCS, Rozzano-Milan', 'class': 'OTHER'}, {'name': 'Humanitas University', 'class': 'OTHER'}, {'name': 'Universita di Verona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}