Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-31 @ 8:29 AM
Study NCT ID:
NCT01453556
Status:
UNKNOWN
Last Update Posted:
2011-10-21
First Post:
2011-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 158}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-10-20', 'studyFirstSubmitDate': '2011-10-13', 'studyFirstSubmitQcDate': '2011-10-17', 'lastUpdatePostDateStruct': {'date': '2011-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative canalisation time and length of stay', 'timeFrame': 'Post-operative stay (about 7 days)', 'description': 'Comparison of post-operative bowel movement time (fist flastus and first dejection) and overall length of stay between the two study groups'}], 'secondaryOutcomes': [{'measure': 'Impact of post-operative ileum and complications. Valuation of global costs', 'timeFrame': '12 months', 'description': 'Comparison of post-operative short and long-term complications (in particular post-operative ileum) between the two study groups. Valuation of global costs differences.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Laparoscopic surgery', 'Right colectomy', 'Mechanical anastomosis', 'Post-operative ileum'], 'conditions': ['Neoplastic or Benign Disease of Right Colon', 'Elective Laparoscopic Surgery']}, 'descriptionModule': {'briefSummary': 'Verify with a prospective randomised trial if intracorporeal mechanical anastomosis in laparoscopic right colectomy reduces post-operative bowel canalisation time and length of stay in comparison with extracorporeal mechanical anastomosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or more\n* Benign o neoplastic disease of right colon\n* Elective laparoscopic surgery\n\nExclusion Criteria:\n\n* Emergency surgery\n* Adhesion or infiltration of near organs\n* Severe heart disease ( New York Heart Association class \\> 3 )\n* Severe respiratory disease ( arterial PO2 \\< 70 torr )\n* Severe Liver disease (Child-Pugh class C)\n* Ongoing infections\n* Number of plasmatic neutrophil \\< a 2.0 x 10 9/L\n* Other contraindications to laparoscopy'}, 'identificationModule': {'nctId': 'NCT01453556', 'briefTitle': 'Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy', 'organization': {'class': 'OTHER', 'fullName': 'Scientific Institute San Raffaele'}, 'officialTitle': 'Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy. A Prospective Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'Intraextra01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intracorpopreal anastomosis', 'description': 'Intracorporeal mechanical anastomosis', 'interventionNames': ['Procedure: Laparoscopic right colectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Extracorporeal anastomosis', 'description': 'Extracorporeal mechanical anastomosis', 'interventionNames': ['Procedure: Laparoscopic right colectomy']}], 'interventions': [{'name': 'Laparoscopic right colectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic right colectomy with mechanical ileo-colon anastomosis L-L', 'armGroupLabels': ['Extracorporeal anastomosis', 'Intracorpopreal anastomosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'MI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'role': 'CONTACT', 'email': 'maxbisso@gmail.com', 'phone': '0039 02 2643 2272'}, {'name': 'Andrea Vignali, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Massimiliano Bissolati, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'San Raffaele Scientific Institute', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Andrea Vignali, MD', 'role': 'CONTACT', 'email': 'maxbisso@gmail.com', 'phone': '0339 02 2643 2272'}], 'overallOfficials': [{'name': 'Andrea Vignali, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Raffaele Scientific Institute'}, {'name': 'Carlo Staudacher, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'San Raffaele Scientific Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scientific Institute San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andrea Vignali', 'investigatorAffiliation': 'Scientific Institute San Raffaele'}}}}