Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-26 @ 1:30 PM
Study NCT ID:
NCT00692393
Status:
COMPLETED
Last Update Posted:
2014-06-19
First Post:
2008-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary vs. Secondary Anastomosis for Hinchey Stage III-IV Diverticulitis a Prospective Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010538', 'term': 'Peritonitis'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-18', 'studyFirstSubmitDate': '2008-06-03', 'studyFirstSubmitQcDate': '2008-06-05', 'lastUpdatePostDateStruct': {'date': '2014-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death rate comparison between two chirurgical strategies', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Peritonitis']}, 'descriptionModule': {'briefSummary': "This study compares primary resection with anastomosis and Hartmann's procedure in an adult population with acute perforated colonic diverticulitis (Hinchey Stage III and IV) METHODS: The primary end point was postoperative mortality. Secondary end points included surgical and medical morbidity, operative time, and length of postoperative hospitalization.", 'detailedDescription': 'inclusion criteria: hinchey III and IV diverticulitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with peritonitis du to sigmoid diverticulum complication\n* Surgeon - anesthetist confirming the 2 surgeries can be performed\n\nExclusion Criteria:\n\n* Physical state which can not permit patient to participate\n* contraindication to surgery\n* non-diverticulum peritonitis'}, 'identificationModule': {'nctId': 'NCT00692393', 'acronym': 'DIVERTI', 'briefTitle': 'Primary vs. Secondary Anastomosis for Hinchey Stage III-IV Diverticulitis a Prospective Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Primary vs. Secondary Anastomosis After Sigmoid Colon Resection for Perforated Diverticulitis (Hinchey Stage III and IV): a Prospective Multicentric Randomized Trial', 'orgStudyIdInfo': {'id': '2006/103/HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Surgery : Hartmann intervention', 'interventionNames': ['Procedure: Hartmann intervention']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Surgery : primary resection with anastomosis with protective stoma', 'interventionNames': ['Procedure: Protected anastomosis resection']}], 'interventions': [{'name': 'Hartmann intervention', 'type': 'PROCEDURE', 'description': 'sigmoid resection, peritoneal and rectal lavage, terminal stoma', 'armGroupLabels': ['1']}, {'name': 'Protected anastomosis resection', 'type': 'PROCEDURE', 'description': 'sigmoid resection , peritoneal and rectal lavage, anastomosis, diverting stoma', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'CHU - Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'JJ TUECH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH Rouen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}