Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT01515150
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2012-01-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Out-patient, Non Antibiotic Management of Patients With Acute Uncomplicated Colonic Diverticulitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004239', 'term': 'Diverticulitis, Colonic'}, {'id': 'D004238', 'term': 'Diverticulitis'}], 'ancestors': [{'id': 'D000076385', 'term': 'Diverticular Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D043963', 'term': 'Diverticulosis, Colonic'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-23', 'studyFirstSubmitDate': '2012-01-18', 'studyFirstSubmitQcDate': '2012-01-20', 'lastUpdatePostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of admission and complications among participant within three months follow-up.', 'timeFrame': 'Three months'}], 'secondaryOutcomes': [{'measure': 'To evaluate reason of hospital admission, late complications, need of bowel rest and costs', 'timeFrame': 'Three months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diverticulitis', 'Out-patient management', 'Antibiotics'], 'conditions': ['Colonic Diverticulitis']}, 'descriptionModule': {'briefSummary': 'Previous multicentre study NCT 01008488 indicates that a patient with CT-proven uncomplicated diverticulitis has a very low risk (1.4%) of developing severe complications such as perforations or abscesses. The question is whether or not hospitalization is necessary, and if patients in that case could return home without antibiotics.\n\nThe purpose of this study is to evaluate if out-patients managements in uncomplicated colonic diverticulitis is possible without readmission or complications.', 'detailedDescription': 'At the emergency room all patients with computed tomography verified acute uncomplicated diverticulitis will be asked about participation in the study. If They accept the participation, They will be send home with pain relief medicine. Every morning a nurse from our colorectal unit call the patient asking about the condition. The patients will have a visit at the surgery unit within 10 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with CT- scan varified acute uncomplicated diverticulitis how are abel to underwent out-patients managment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (age above 18 years, acute abdominal pain (Duration\\< 3 days), abdominal tenderness, elevated inflammatory parameters, CT- scan sign of uncomplicated diverticulitis(without sign of abscess or free air).\n\nExclusion Criteria:\n\n* diffuse peritonitis sepsis or abscess, drying Patients who are unable to intake of fluids orally, severe pain with need of repeated parenteral morphine treatment, immunological deficient patients incl. steroid treatment, pregnancy, dementia, patients who need hospitalization of other reasons'}, 'identificationModule': {'nctId': 'NCT01515150', 'acronym': 'P-VOD', 'briefTitle': 'The Out-patient, Non Antibiotic Management of Patients With Acute Uncomplicated Colonic Diverticulitis', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Management of Patients With Uncomplicated Diverticulitis as Out-patient and Without Antibiotics', 'orgStudyIdInfo': {'id': 'P-VOD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Out-patients in diverticulitis', 'description': 'All patient with acute uncomplicated diverticulitis how accept participation in the study will be enrolled in the study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72189', 'city': 'Västerås', 'state': 'Västmanland County', 'country': 'Sweden', 'facility': 'Colorectal unit, department of surgery Västmanland Hospital Västerås', 'geoPoint': {'lat': 59.61617, 'lon': 16.55276}}], 'overallOfficials': [{'name': 'Mats Enlund, Ass. Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Centre of Clinical Research of Uppsala University, Västmanlands Hospital Västerås'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}