NCT06261151

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

February 8, 2024

Last Update Submit

February 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The preoperative nutritional status of elderly patients underwent gastrectomy

    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: \[(10×serum albumin (g/dL)) + (0.005×total lymphocyte count (/mm3))\].

    March 01, 2024 to December 31, 2024.

Interventions

Clinical data of elderly patients with gastric cancer who underwent open gastrectomy were collected and analyzed.

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • Patients aged 60-90 years old; Patients with gastric cancer; Patients who underwent radical gastrectomy. -

You may not qualify if:

  • Patients with other malignancies; Patients with previous gastrointestinal surgery or emergency surgery; Patients with incomplete medical record.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2024

First Posted

February 15, 2024

Study Start

March 1, 2024

Primary Completion

December 31, 2024

Study Completion

March 31, 2025

Last Updated

February 15, 2024

Record last verified: 2024-02