Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT04578405
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2020-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intracorporeal Anastomosis Accelerates Bowel Function in Comparison to Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy - a Randomized Control Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-02', 'studyFirstSubmitDate': '2020-10-02', 'studyFirstSubmitQcDate': '2020-10-02', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first stool', 'timeFrame': '5 days'}], 'secondaryOutcomes': [{'measure': 'Time to first flatus', 'timeFrame': '5 days'}, {'measure': 'Complications', 'timeFrame': '30 day'}, {'measure': 'Length of surgery', 'timeFrame': '1 day'}, {'measure': 'Length of hospital stay', 'timeFrame': '30 day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Right Hemicolectomy']}, 'descriptionModule': {'briefSummary': 'Both extracorporeal and intracorporeal anastomosis in laparoscopic right hemicolectomy are renowned and performed worldwide. Many observational studies show conflicting results which method is better. This randomized control trial aimed to assess which technique is superior.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* malignant or benign neoplasm located in right side of the colon\n\nExclusion Criteria:\n\n* stage IV disease\n* conversion\n* inflammatory bowel diseases\n* corticosteroid intake\n* immunodeficiency\n* emergency surgery\n* neoadjuvant therapy\n* no technical possibility to perform either anastomosis'}, 'identificationModule': {'nctId': 'NCT04578405', 'briefTitle': 'Intracorporeal Anastomosis Accelerates Bowel Function in Comparison to Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy - a Randomized Control Trial.', 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': 'Intracorporeal Anastomosis Accelerates Bowel Function in Comparison to Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy - a Randomized Control Trial.', 'orgStudyIdInfo': {'id': 'JagiellonianU-6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Extracorporeal anastomosis', 'interventionNames': ['Procedure: Extracorporeal anastomosis']}, {'type': 'EXPERIMENTAL', 'label': 'Intracorporeal anastomosis', 'interventionNames': ['Procedure: Intracorporeal anastomosis']}], 'interventions': [{'name': 'Intracorporeal anastomosis', 'type': 'PROCEDURE', 'description': 'Anastomosis performed totally laparoscopically', 'armGroupLabels': ['Intracorporeal anastomosis']}, {'name': 'Extracorporeal anastomosis', 'type': 'PROCEDURE', 'description': 'Anastomosis performed through a minilaparotomy', 'armGroupLabels': ['Extracorporeal anastomosis']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jagiellonian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Michał Pędziwiatr', 'investigatorAffiliation': 'Jagiellonian University'}}}}