Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT04665427
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2020-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Factors Influencing Occurrence of Bile Leaks in Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001658', 'term': 'Biliary Fistula'}], 'ancestors': [{'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-22', 'studyFirstSubmitDate': '2020-11-29', 'studyFirstSubmitQcDate': '2020-12-10', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The occurrence of a bile leak in the postoperative period (Day 0 to Day 90).', 'timeFrame': 'From (day 0) of surgery to (day 90)', 'description': 'Occurrence of a bile leak visible through a drain, through the wound, visible on the control radiology, or after the occurrence of a peritoneal collection or biliary peritonitis.'}], 'secondaryOutcomes': [{'measure': 'Postoperative hospital stay', 'timeFrame': 'From (day 0) of surgery to (day 90)', 'description': 'length of postoperative hospital stay'}, {'measure': 'Mortality', 'timeFrame': 'From day 0 to day 90', 'description': 'Mortality after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hepatobiliary surgery', 'Morbidity', 'leak', 'anastomosis'], 'conditions': ['Bile Leak', 'Anastomotic Leak Biliary', 'Biliary Tract Fistula']}, 'descriptionModule': {'briefSummary': 'The objective of our study is to identify the factors influencing the occurrence of a biliary leak after performing surgery leading to the creation of a biliary anastomosis to any segment of the digestive tract.', 'detailedDescription': 'The objective of our study is to identify the factors influencing the occurrence postoperative of biliary leaks, Sex, Age, BMI, Bilirubin level, Protein level, and surgical technique (And other factors)are analyzed to study their influence on occurrence of postoperative biliary leak.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient who has undergone a surgical bilioenteric anastomosis for any etiology.\n\nExclusion Criteria:\n\n* Any patient who has undergone a nonsurgical (endoscopic / radiological) bilioenteric anastomosis.\n* Subjects under the age of 18. Years.\n* Subjects who refused to participate in this study.\n* Cases of biliary and pancreatic anastomoses performed during the same surgery.'}, 'identificationModule': {'nctId': 'NCT04665427', 'briefTitle': 'Factors Influencing Occurrence of Bile Leaks in Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Oran 1'}, 'officialTitle': 'Factors That Influence the Occurrence of Bile Leaks After Biliary Anastomosis Surgery', 'orgStudyIdInfo': {'id': 'UOran1_surgery_Bile_leak'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patient in whom a bilioenteric anastomosis is performed for any etiology.', 'description': 'Patient in whom a bilioenteric anastomosis is performed for any etiology..', 'interventionNames': ['Other: bilioenteric anastomosis i']}], 'interventions': [{'name': 'bilioenteric anastomosis i', 'type': 'OTHER', 'otherNames': ['hepatico duodenostomy', 'hepaticojejunostomy'], 'description': 'The creation of communication between a bile duct and a segment of the digestive tract, often to restore a flow of bile in the digestive tract,', 'armGroupLabels': ['Patient in whom a bilioenteric anastomosis is performed for any etiology.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Oran', 'country': 'Algeria', 'facility': 'Departmenet of hepatobiliary surgery, EHU-1st November 1954, Oran.', 'geoPoint': {'lat': 35.69906, 'lon': -0.63588}}], 'overallOfficials': [{'name': 'Benali Tabeti, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'University Oran1'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oran 1', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Anisse Tidjane', 'investigatorAffiliation': 'University of Oran 1'}}}}