Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT01239927
Status:
COMPLETED
Last Update Posted:
2010-11-15
First Post:
2010-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hartmann vs R/A in Peritonitis by Perforated Diverticulitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-12', 'studyFirstSubmitDate': '2010-11-12', 'studyFirstSubmitQcDate': '2010-11-12', 'lastUpdatePostDateStruct': {'date': '2010-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day mortality and morbidity after emergency surgery', 'timeFrame': '30-day'}], 'secondaryOutcomes': [{'measure': '30-day mortality and morbidity after elective restoration of intestinal transit', 'timeFrame': '30 day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diverticulitis', 'hartmann', 'anastomosis'], 'conditions': ['Peritonitis Caused by Perforated Left-sided Colon Diverticulitis']}, 'descriptionModule': {'briefSummary': 'This prospective randomized trial is to prove the equivalence of primary sigmoid resection with end colostomy(Hartmann)(GROUP A) and primary sigmoid resection and immediate anastomosis with diverting stoma (GROUP B)with regard to morbidity and mortality in patients with peritonitis caused by perforated left-sided colon diverticulitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intraoperative demonstrated peritonitis caused by perforated left-sided colon diverticulitis\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01239927', 'briefTitle': 'Hartmann vs R/A in Peritonitis by Perforated Diverticulitis', 'organization': {'class': 'OTHER', 'fullName': 'Ente Ospedaliero Ospedali Galliera'}, 'officialTitle': 'Hartmann vs Resection With Anastomosis and Diverting Stoma for Peritonitis Caused by Perforated Left-sided Colon Diverticulitis: a Multicenter Prospective Randomized Study.', 'orgStudyIdInfo': {'id': 'PRTHRAPDP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Primary sigmoid resection with end colostomy (Hartmann)', 'type': 'PROCEDURE'}, {'name': 'Primary sigmoid resection and immediate anastomosis with diverting stoma (PRA)', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16100', 'city': 'Genova', 'state': 'Genova', 'country': 'Italy', 'facility': 'Gian Andrea Binda', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}], 'overallOfficials': [{'name': 'Roberto Bergamaschi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Colon & Rectal Surgery State University of New York Stony Brook, New York'}, {'name': 'Gian Andrea Binda', 'role': 'STUDY_DIRECTOR', 'affiliation': 'EO Ospedali Galliera, Genova, Italy'}, {'name': 'Alberto Serventi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'EO Ospedali Galliera, Genova, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ente Ospedaliero Ospedali Galliera', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Gian Andrea Binda MD', 'oldOrganization': 'Ente Ospedaliero Ospedali Galliera'}}}}