- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06261151
Preoperative Nutritional Status Associated With Delayed Discharge in Elderly Patients Undergoing Gastrectomy
Preoperative Nutritional Status and Risk Factors Associated With Delayed Discharge in Elderly Patients Undergoing Gastrectomy: A Single-center Retrospective Study
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.
In 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.
Previous 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients aged 60-90 years old; Patients with gastric cancer; Patients who underwent radical gastrectomy. -
Exclusion Criteria:
Patients with other malignancies; Patients with previous gastrointestinal surgery or emergency surgery; Patients with incomplete medical record.
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Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The preoperative nutritional status of elderly patients underwent gastrectomy
Time Frame: March 01, 2024 to December 31, 2024.
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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))].
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March 01, 2024 to December 31, 2024.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Zhongshan-HHY-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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