Predictive Value of NRS2002 and GLIM for Complications After GI Malignancy Surgery

NCT ID: NCT07104175

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 471 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2025-01-01

Brief Summary

This prospective cohort study investigates and compares the predictive power of two nutritional assessment tools, the Nutritional Risk Screening 2002 (NRS2002) and the Global Leadership Initiative on Malnutrition (GLIM) criteria. The study aims to determine how well these tools can predict postoperative complications in patients with gastrointestinal malignancies who are undergoing surgical resection.

Detailed Description

Malnutrition is a common and severe problem in patients with gastrointestinal (GI) malignancies, adversely affecting surgical outcomes. This prospective cohort study was designed to evaluate and compare the predictive utility of two key nutritional assessment tools. Patients scheduled for elective curative-intent surgery for GI malignancies were enrolled. Within 24 hours of admission, each patient's nutritional status was assessed using both the Nutritional Risk Screening 2002 (NRS2002) and the Global Leadership Initiative on Malnutrition (GLIM) criteria. The study followed these patients through their hospital stay and post-discharge to collect data on the primary outcome of postoperative complications, as well as secondary outcomes including length of hospital stay, hospitalization costs, and unplanned 30-day and 60-day readmissions. The objective is to provide evidence to guide clinicians in using NRS2002 and GLIM for preoperative risk stratification and to identify patients who may benefit from nutritional interventions to improve surgical outcomes.

Conditions

Gastrointestinal Malignancies

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Nutritional Risk Group (NRS2002 ≥ 3)

Patients identified as being at nutritional risk based on the Nutritional Risk Screening 2002 (NRS2002) score (total score ≥ 3), assessed preoperatively within 24 hours of admission. These patients were followed to assess for postoperative outcomes.

No interventions assigned to this group

No Nutritional Risk Group (NRS2002 < 3)

Patients identified as not being at significant nutritional risk based on the NRS2002 score (total score \< 3), assessed preoperatively within 24 hours of admission. These patients served as the control group for the NRS2002 exposure and were followed to assess for postoperative outcomes.

No interventions assigned to this group

Malnutrition Group (GLIM Criteria)

Patients diagnosed with malnutrition based on the Global Leadership Initiative on Malnutrition (GLIM) criteria, requiring at least one phenotypic and one etiologic criterion. Assessment was performed preoperatively within 24 hours of admission. Patients were followed to assess for postoperative outcomes. This group was also sub-categorized into moderate and severe malnutrition.

No interventions assigned to this group

No Malnutrition Group (GLIM Criteria)

Patients who did not meet the GLIM criteria for malnutrition. Assessment was performed preoperatively within 24 hours of admission. These patients served as the control group for the GLIM exposure and were followed to assess for postoperative outcomes.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years.
• Histopathologically confirmed primary gastrointestinal malignancy (e.g., esophageal, gastric, colorectal cancer).
• Planned curative-intent surgical resection.
• No prior anti-tumor treatments such as surgery, radiotherapy, chemotherapy, or immunotherapy for the current malignancy.
• Provision of written informed consent to participate in the study.

Exclusion Criteria

• Presence of other concurrent systemic malignant tumors.
• Emergency surgery.
• Hospital stay less than 48 hours post-surgery.
• Incomplete critical clinical or nutritional data.
• Refusal to participate.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third central hospital of Tianjin affiliated Nankai university

NETWORK

Sponsor Role: lead

Responsible Party

Dongping Xu

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Third Central Hospital of Tianjin

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

SZX-IRB-SOP-016(F)-002-01

Identifier Type: -

Identifier Source: org_study_id