Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-28 @ 8:13 AM
Study NCT ID:
NCT00503334
Status:
COMPLETED
Last Update Posted:
2008-12-08
First Post:
2007-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}], 'ancestors': [{'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-05', 'studyFirstSubmitDate': '2007-07-16', 'studyFirstSubmitQcDate': '2007-07-17', 'lastUpdatePostDateStruct': {'date': '2008-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP;', 'timeFrame': 'up to 30 days after surgery'}], 'secondaryOutcomes': [{'measure': 'postoperative complications, pre- and postoperative discomfort (well-being), muscle strength at 7 days post-op, length of stay (hospital / ICU), ambulation time, gastro intestinal tolerance', 'timeFrame': 'up to 30 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Enteral Nutrition (Food for Special Medical Purposes)']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to investigate the effect of an oral nutritional supplement (preOP booster) versus placebo regarding metabolic criteria in patients undergoing elective pancreaticoduodenectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective pancreaticoduodenectomy\n\nExclusion Criteria:\n\n* Concomitant chemotherapy\n* Severe malnutrition (SGA score C)\n* Conditions affecting gastric emptying'}, 'identificationModule': {'nctId': 'NCT00503334', 'briefTitle': 'Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Kabi'}, 'officialTitle': 'Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (preOP Booster) Versus Placebo in Visceral Surgery', 'orgStudyIdInfo': {'id': 'N-POB-03-IT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'preOP booster', 'interventionNames': ['Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'preOP booster placebo', 'interventionNames': ['Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes)']}], 'interventions': [{'name': 'preOP booster (oral nutritional supplement, food for special medical purposes)', 'type': 'DIETARY_SUPPLEMENT', 'description': '3x1 dosage pre-operatively', 'armGroupLabels': ['preOP booster', 'preOP booster placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Università Salute-Vita San Raffaele,', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Marco Braga, Prof MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università Salute-Vita San Raffaele, Milan, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Kabi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. Steffen Benzing', 'oldOrganization': 'Fresenius Kabi Deutschland GmbH'}}}}