Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT05476159
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2022-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Indocyanine Green Test in Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D057868', 'term': 'Anastomotic Leak'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015390', 'term': 'Gastric Bypass'}], 'ancestors': [{'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005763', 'term': 'Gastroenterostomy'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-20', 'size': 137532, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-07-25T17:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-25', 'studyFirstSubmitDate': '2022-07-23', 'studyFirstSubmitQcDate': '2022-07-25', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive Intraoperative Indocyanine green test', 'timeFrame': 'During surgery (within 150-180 minutes)', 'description': 'Intraoperative indocyanine green test was performed'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Obesity, Morbid', 'Surgery', 'Leak, Anastomotic']}, 'referencesModule': {'references': [{'pmid': '36536736', 'type': 'DERIVED', 'citation': 'Pavone G, Fersini A, Pacilli M, Cianci P, Ambrosi A, Tartaglia N. Anastomotic leak test using indocyanine green during laparoscopic Roux-en-Y gastric bypass: A cohort study. Ann Med Surg (Lond). 2022 Nov 17;84:104939. doi: 10.1016/j.amsu.2022.104939. eCollection 2022 Dec.'}]}, 'descriptionModule': {'briefSummary': 'Indocyanine green (ICG) can be injected into the human bloodstream and it allows us to show stomach vascularity in real time'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The aim of our study is to observe the preliminary results of the application of indocyanine green fluorescence (IGF) during laparoscopic Roux-en-Y Gastric Bypass (RYGB in our center and how the perfusion of the gastro-jejunal anastomosis affects the onset of fistula.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI\\>40kg/m2\n\nExclusion Criteria:\n\n* Non obese patients'}, 'identificationModule': {'nctId': 'NCT05476159', 'briefTitle': 'Indocyanine Green Test in Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Foggia'}, 'officialTitle': 'Anastomotic Leak Test Using Indocyanine Green During Laparoscopic Roux-en-y Gastric Bypass', 'orgStudyIdInfo': {'id': '5'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Indocyanine green solution', 'type': 'DRUG', 'description': 'Adequate perfusion was defined as "the direct and clear visualization of the fluorescence along the gastric tube, relative to the excised specimen, after an estimated time of 150-180 s after i.v. administration injection'}, {'name': 'Gastric bypass', 'type': 'DEVICE', 'description': 'Roux and Y Gastric bypass'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71122', 'city': 'Foggia', 'country': 'Italy', 'facility': 'University of Foggia', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}], 'overallOfficials': [{'name': 'Giovanna Pavone', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Foggia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Foggia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Giovanna Pavone', 'investigatorAffiliation': 'University of Foggia'}}}}