Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT06261151
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-15
First Post:
2024-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Nutritional Status Associated With Delayed Discharge in Elderly Patients Undergoing Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2024-02-08', 'studyFirstSubmitQcDate': '2024-02-14', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The preoperative nutritional status of elderly patients underwent gastrectomy', 'timeFrame': 'March 01, 2024 to December 31, 2024.', 'description': 'According to the European Society for Clinical Nutrition and Metabolism (ESPEN) diagnostic criteria, malnutrition is defined as a weight loss of more than 10% (indefinite of time) or more than 5% over the last 3 months and a body mass index (BMI)\\<20 kg/m2 or \\<22 kg/m2 in patients under or above the age of 70, respectively. Nutritional assessment is performed based on a prognostic nutritional index (PNI), which is calculated based on the equation: \\[(10×serum albumin (g/dL)) + (0.005×total lymphocyte count (/mm3))\\].'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preoperative Nutritional Status and Risk Factors Associated With Elderly Patients Undergoing Gastrectomy']}, 'descriptionModule': {'briefSummary': 'Gastric cancer (GC) remains the 5th most common cancer worldwide and had the second- highest mortality rate in China. The population of elder patients with GC has been increasing because of the high prevalence of H. pylori infection and increasing life expectancy. Elderly GC patients face several challenges during treatment, such as comorbidities, organ dysfunction, immunosuppression, and delayed recovery. Advanced age is associated with a higher rate of postoperative complications shortly after surgical treatment, and lower 5-year overall survival as long-term outcome.\n\nIn China, the prevalence of malnutrition in hospitalized patients is around 12.6% to 46.19%. Malnutrition is one of the great risk factors of adverse clinical outcomes in elderly patients with GC. The nutritional status at the time of diagnosis was independently associated with postoperative complications, overall survival, and disease-free survival. The condition can be caused by mechanical obstruction of the digestive tract or anorexia-cachexia syndrome, leading to insufficient protein or energy intake and absorption disorder. Nutrition screening, assessment, and intervention are important steps in nutritional management.\n\nPrevious studies mostly focused on hospitalized internal medical patients. Only a few studies focused on surgical patients regardless of age. Therefore, in this retrospective study, we are going to investigate the nutritional status and perioperative nutritional support of geriatric surgical patients with GC, and provide a basis for implementing an effective nutritional intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 60-90 years old with gastric cancer who underwent radical gastrectomy were retrospectively analyzed from the prospectively collected database of Zhongshan Hospital of Fudan University between March 2024 and December 2024.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients aged 60-90 years old; Patients with gastric cancer; Patients who underwent radical gastrectomy. -\n\nExclusion Criteria:\n\nPatients with other malignancies; Patients with previous gastrointestinal surgery or emergency surgery; Patients with incomplete medical record.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06261151', 'briefTitle': 'Preoperative Nutritional Status Associated With Delayed Discharge in Elderly Patients Undergoing Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Preoperative Nutritional Status and Risk Factors Associated With Delayed Discharge in Elderly Patients Undergoing Gastrectomy: A Single-center Retrospective Study', 'orgStudyIdInfo': {'id': 'Zhongshan-HHY-03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Clinical data collection', 'type': 'OTHER', 'description': 'Clinical data of elderly patients with gastric cancer who underwent open gastrectomy were collected and analyzed.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}