Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-29 @ 1:42 AM
Study NCT ID:
NCT05235204
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2021-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007412', 'term': 'Intestinal Fistula'}], 'ancestors': [{'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-16', 'size': 392790, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-06-07T16:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2021-12-16', 'studyFirstSubmitQcDate': '2022-02-10', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of positive urine leak on post-operative day 3 cystogram', 'timeFrame': 'up to 3 days post surgery', 'description': 'Participants cystograms will be reviewed to detect positive urine leak, 2 to 3 days post surgery.'}], 'secondaryOutcomes': [{'measure': 'Foley catheter re-insertion', 'timeFrame': 'up to 5 days post-surgery', 'description': 'Participants who will require re-insertion of the foley catheter once it is removed on post-operative day 3'}, {'measure': 'Re-operations within 30 days of initial surgery', 'timeFrame': 'up to 30 days post discharge', 'description': 'Patients who have required return to the OR within 30 days after discharge.'}, {'measure': 'Hospital re-admission', 'timeFrame': 'up to 30 days post- discharge', 'description': 'Patients who have required readmission to the hospital within 30 days after discharge.'}, {'measure': 'Symptomatic post-operative urinary tract infection', 'timeFrame': 'up to days post discharge', 'description': 'Patients who have had a symptomatic urinary tract infection within 30 days after discharge.'}, {'measure': 'Post operative urinary sepsis', 'timeFrame': 'up to 30 days post discharge', 'description': 'Patients who have urinary sepsis either prior to discharge or within 30 days after discharge.'}, {'measure': 'Recurrence of colovesical fistula', 'timeFrame': 'up to 30 days post-discharge', 'description': 'Patients who had recurrence of their colovesical fistula within 30 days of discharge.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colovesical Fistula']}, 'descriptionModule': {'briefSummary': 'Patients undergoing surgical repair of colovesical fistula will have have "early" (post-operative day 3) cystogram and removal of bladder catheter. Outcomes from the "early" group will be compared to historical "late" group data to determine if early bladder catheter removal is safe.', 'detailedDescription': 'There is defined time for foley/bladder catheter removal after colovesical fistula repair in the current surgical literature. This study will be a prospective cohort study evaluating outcomes after early foley catheter removal (on post-operative day 3), specifically bladder leak, 30-day readmissions and adverse events. This cohort will be compared to a retrospective "late" group, who had foley catheter removal later in their hospital course.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 and over\n* Undergoing surgical repair of diverticular colovesical fistula\n\nExclusion Criteria:\n\n* Patients with active and untreated genitourinary cancers\n* Subjects with known or suspected Inflammatory Bowel Disease as the cause of colovesical fistula.\n* Individuals who are not expected to regain normal bladder function after surgery as defined by either pre-existing bladder dysfunction with chronic indwelling urinary catheter, supra-pubic catheter, or surgical urinary diversion\n* Individuals who require re-operation prior to Foley removal\n* Adults unable to consent\n* Pregnant women\n* Prisoners\n* Individuals who are not yet adults (infants, children, teenagers less than 18 years old)'}, 'identificationModule': {'nctId': 'NCT05235204', 'briefTitle': 'Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair', 'orgStudyIdInfo': {'id': 'H00016345'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Foley catheter removal day 2 or 3 post-operative procedure', 'description': 'According to review of internal clinical practices, the average duration of catheterization after Colovesical Fistula (CVF) repair is 10.8 days after CVF repair. The intervention in this study removes the Foley Catheter at 2 to 3 days post CVF repair.', 'interventionNames': ['Procedure: Removal of Foley Catheter 2 to 3 days post Colovesical Fistula (CVF) repair surgery']}], 'interventions': [{'name': 'Removal of Foley Catheter 2 to 3 days post Colovesical Fistula (CVF) repair surgery', 'type': 'PROCEDURE', 'description': 'According to review of internal clinical practices, the average duration of catheterization after Colovesical Fistula (CVF) repair is 10.8 days after CVF repair. The intervention in this study removes the Foley Catheter at 2 to 3 days post CVF repair.', 'armGroupLabels': ['Foley catheter removal day 2 or 3 post-operative procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karim Alavi, MD', 'role': 'CONTACT', 'email': 'karim.alavi@umassmemorial.org', 'phone': '508-334-1312'}, {'name': 'Karen Berni-Giarusso, RN', 'role': 'CONTACT', 'email': 'karen.berni-giarusso@umassmed.edu', 'phone': '5088561888'}, {'name': 'Karim Alavi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UMass Memorial Medical Center Memorial Campus', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'centralContacts': [{'name': 'Karim Alavi, MD, MPH', 'role': 'CONTACT', 'email': 'karim.alavi@umassmemorial.org', 'phone': '508-334-8195'}], 'overallOfficials': [{'name': 'KArin Alavi, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMass Chan Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karim Alavi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Karim Alavi', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}