Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-03-09 @ 4:28 AM
Study NCT ID:
NCT03934151
Status:
COMPLETED
Last Update Posted:
2019-05-01
First Post:
2019-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1225}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-30', 'studyFirstSubmitDate': '2019-04-26', 'studyFirstSubmitQcDate': '2019-04-30', 'lastUpdatePostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anastomotic complications', 'timeFrame': 'maximum 30 days', 'description': 'number of anastomotic complications after right hemicolectomy when ileocolic anastomosis is performed with intracorporeal or extracorporeal technique'}, {'measure': 'Postoperative day of discharge', 'timeFrame': '4 to 30 days', 'description': 'the lenght of stay in hospital measured in days after right hemicolectomy with ileocolic anastomosis performed with intracorporeal or extracorporeal technique'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laparoscopy', 'ileocolic anastomosis', 'right hemicolectomy'], 'conditions': ['Complication of Gastrointestinal Anastomosis', 'Intestinal Anastomosis Complication']}, 'referencesModule': {'references': [{'pmid': '31741153', 'type': 'DERIVED', 'citation': 'Anania G, Agresta F, Artioli E, Rubino S, Resta G, Vettoretto N, Petz WL, Bergamini C, Arezzo A, Valpiani G, Morotti C, Silecchia G; SICE CoDIG (Colon Dx Italian Group). Laparoscopic right hemicolectomy: the SICE (Societa Italiana di Chirurgia Endoscopica e Nuove Tecnologie) network prospective trial on 1225 cases comparing intra corporeal versus extra corporeal ileo-colic side-to-side anastomosis. Surg Endosc. 2020 Nov;34(11):4788-4800. doi: 10.1007/s00464-019-07255-2. Epub 2019 Nov 18.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to analyze the postoperative complication rate of intracorporeal versus extracorporeal anastomotic technique in laparoscopic or video assisted right hemicolectomy for malignant and benign neoplasms . The lead center is the General and Thoracic Surgery Department of the University of Ferrara. Prof. Anania is the responsible for the enrollment of patients and the coordination with the collaborating centers in the six month-study', 'detailedDescription': 'CoDIG is a cohort, observational, prospective, multi-centric national study about ileo-colic anastomosis performing with EC or IC Technique during right laparoscopic hemicolectomy.\n\nThe observational period lasts from march 2018 and September 2018. The promoter of the study is "Istituto di Chirurgia Generale 1" of Ferrara University Hospital.\n\n135 Italian Hospitals, accredited by Health Ministry, have been contacted via e-mail and all data was compiled into a web accessible SICE database, 85 Italian clinical centres, with demonstrated experience in colorectal laparoscopic surgery, have joined the study.\n\nEvery centre was asked not to change its surgical habits concerning the technologies used, the surgical approach, the anastomotic method, the post-operative management.\n\nEvery patient involved into the study was asked to sign a consent form in order to the Helsinki Declaration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients affected by malignant or benign pathology of the right colon treated in italian surgical centers accredited by the Ministry of Public Health', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients and/or legal guardians exhaustively informed by the investigator, and who have voluntarily provided written informed consent or, when unable to read and/or write, verbal consent put into writing by a third person\n* Patients who underwent elective laparoscopic or video assisted right hemicolectomy at U.O. General and Thoracic Surgery for malignant or bening pathology.\n* Patients who had prior chemotherapy and radiotherapy\n\nExclusion Criteria:\n\n* Patients operated in emergency\n* Pregnant women\n* Right laparotomic hemicolectomy\n* BMI\\> 35'}, 'identificationModule': {'nctId': 'NCT03934151', 'acronym': 'CoDIG', 'briefTitle': 'Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Ferrara'}, 'officialTitle': 'Multicenter National Observational Study on Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy', 'orgStudyIdInfo': {'id': '170595'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'intracorporeal anastomosis', 'description': 'patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with intracorporeal technique', 'interventionNames': ['Procedure: intracorporeal ileocolic anastomosis']}, {'label': 'extracorporeal anastomosis', 'description': 'patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with extracorporeal technique', 'interventionNames': ['Procedure: extracorporeal ileocolic anastomosis']}], 'interventions': [{'name': 'intracorporeal ileocolic anastomosis', 'type': 'PROCEDURE', 'description': 'laparoscopic bowel transection and ileocolic anastomosis performed inside the abdomen with specimen retrieval in plastic bag', 'armGroupLabels': ['intracorporeal anastomosis']}, {'name': 'extracorporeal ileocolic anastomosis', 'type': 'PROCEDURE', 'description': 'ileocolic anastomosis is carried out by exteriorizing the bowel through a limited laparotomy', 'armGroupLabels': ['extracorporeal anastomosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adria', 'country': 'Italy', 'facility': 'ULSS5 Polesa - Ospedale di Adria', 'geoPoint': {'lat': 45.05445, 'lon': 12.05599}}, {'city': 'Alba', 'country': 'Italy', 'facility': 'San Lazzaro Alba', 'geoPoint': {'lat': 44.6999, 'lon': 8.0347}}, {'city': 'Andria', 'country': 'Italy', 'facility': 'Ospedale Civile L. 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