Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT05069402
Status:
UNKNOWN
Last Update Posted:
2021-10-14
First Post:
2021-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Various Diets on Surgical Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093702', 'term': 'Immunonutrition Diet'}], 'ancestors': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The physician is unaware of the type of the intervention. The type of intervention is given by the independent person to dietitian instructing the patient how to use the product.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomisation into 3 arms'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-06', 'studyFirstSubmitDate': '2021-09-25', 'studyFirstSubmitQcDate': '2021-09-25', 'lastUpdatePostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical complications', 'timeFrame': '6 months', 'description': 'Number and type of surgical complications'}, {'measure': 'Infectious complications', 'timeFrame': '6 months', 'description': 'Number and type of infectious complications'}], 'secondaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': '6 months', 'description': 'Days of hospital stay after the operation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complication,Postoperative']}, 'descriptionModule': {'briefSummary': 'The optimalisation of the health status of patients scheduled for major surgery has been considered to be the most important point of perioperative care, and nutritional intervention has been perceived a key point of that intervention. Immunomodulating diets were thought to reduce cmplications, hoever recent studies put that opnion in doubt. This study was designed to assess the actual clinical significance of oral immunonutrition.', 'detailedDescription': 'The optimalisation of the health status of patients scheduled for major surgery has been considered to be the most important point of perioperative care, and nutritional intervention has been perceived a key point of that intervention. Italian studies followed by metanalyses demonstrated the superiority of immunomodulating diets (IM) over any other preoperative nutrition, hence the surgical guidelines for enteral nutrition published by European Society for Clinical Nutrition and Metabolism (ESPEN) in 2006 recommended to use IM for 7-14 days preoperatively in all patients undergoing major surgeries. Some authors questioned IM by showing no benefit of IM over standard enteral nutrition. Other authors observed similar results.The debate was far from being over - in 2015 a new metanalysis stated that perioperative enteral nutrition is the best option for managing clinical status of patients who underwent selective surgery for gastrointestinal cancer. One year later, ESPEN changed its surgical recommendations and advised to use IM preoperatively in malnourished and perioperatively in well-nourished patients. American recommendations remained unchanged and, according to them, it is advised to use IM preoperatively in all surgical patients, however, high-protein nutrition could also be an beneficial option.\n\nTo address those doubts and to assess the actual clinical significance of oral immunonutrition, a randomized, two center, prospective clinical trial was conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no sign of malnutrition (defined as one of the following unintentional weight loss by at least 10% or body mass index (BMI) \\< 18),\n* good general status (Karnofsky Performance Index \\> 80,\n* Eastern Cooperative Oncology Group (ECOG) grade 0 or 1);\n* no confirmed neoplastic dissemination no severe concomitant disease (heart, lung, kidney, liver failure, chronic obstructive pulmonary disease \\[COPD\\], coronary aortic bypass graft \\[CABG\\], etc.),\n* no history of known allergies or drug intolerance to analyzed substances.\n\nExclusion Criteria:\n\n* Patients malnourished or with metastatic disease,\n* pregnant,\n* in poor general status (Karnofsky \\<80, Eastern Cooperative Oncology Group (ECOG) \\> 1),\n* recent history of severe heart, lung, kidney or liver failure,\n* history of allergies or drug intolerance'}, 'identificationModule': {'nctId': 'NCT05069402', 'acronym': 'IMM4', 'briefTitle': 'Impact of Various Diets on Surgical Complications', 'organization': {'class': 'OTHER', 'fullName': "Stanley Dudrick's Memorial Hospital"}, 'officialTitle': 'Impact of Immunomodulating Oral Nutrition on Surgical Complications', 'orgStudyIdInfo': {'id': '4armsimmuno'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immunonutrition', 'description': 'Oral immunonutrition containing arginine, omega-PUFAs and antioxidants', 'interventionNames': ['Dietary Supplement: Immunonutrition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High-protein diet', 'description': 'Oral nutrition with high-protein content', 'interventionNames': ['Dietary Supplement: High-protein']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard nutrition', 'description': 'Oral nutrition with standard components', 'interventionNames': ['Dietary Supplement: Standard ONS']}], 'interventions': [{'name': 'Immunonutrition', 'type': 'DIETARY_SUPPLEMENT', 'description': 'diet with immunonutrients', 'armGroupLabels': ['Immunonutrition']}, {'name': 'High-protein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral nutrition with high-protein content', 'armGroupLabels': ['High-protein diet']}, {'name': 'Standard ONS', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral nutrition with standard ingredients', 'armGroupLabels': ['Standard nutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31-115', 'city': 'Krakow', 'state': 'Malopolska', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Stanislaw Klek, PhD', 'role': 'CONTACT', 'email': 'stanislaw.klek@onkologia.krakow.pl', 'phone': '60293566'}], 'facility': 'Narodowy Instytut Onkologii', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '32-050', 'city': 'Skawina', 'state': 'Malopolska', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': "Stanley Dudrick's M Hospital", 'role': 'CONTACT', 'email': 'klek@poczta.onet.pl', 'phone': '604293566'}, {'role': 'CONTACT', 'email': 'klek@poczta.onet.pl', 'phoneExt': 'Klek'}, {'name': 'Stanislaw Klek', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Stanley Dudrick's Memorial Hospital", 'geoPoint': {'lat': 49.97524, 'lon': 19.82869}}], 'centralContacts': [{'name': 'Stanislaw Klek, PhD', 'role': 'CONTACT', 'email': 'klek@poczta.onet.pl', 'phone': '+48604293566'}], 'overallOfficials': [{'name': 'Stanislaw Klek, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Stanley Dudrick's Memorial Hospital"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': '12 months', 'ipdSharing': 'YES', 'accessCriteria': 'any health professional'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Stanley Dudrick's Memorial Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Unit', 'investigatorFullName': 'Stanislaw Klek', 'investigatorAffiliation': "Stanley Dudrick's Memorial Hospital"}}}}