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

NCT07104175 | Completed

• 1 other identifier: SZX-IRB-SOP-016(F)-002-01
• Study Type: observational
• Target: 471
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Malignancies

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Complications

  Measured as the number of patients experiencing one or more postoperative complications. Complications were defined and graded according to the Clavien-Dindo classification system and the "Expert Consensus on Postoperative Complications Registration for Gastrointestinal Tumor Surgery (2018 Edition)". Major complications were defined as Clavien-Dindo grade III or higher.

  Up to 30 days post-surgery

Secondary Outcomes (4)

• Length of Hospital Stay

  Up to 60 days post-surgery (data collected at discharge)

• Intensive Care Unit (ICU) Admission Rate

  Up to 30 days post-surgery

• Unplanned 30-Day Readmission Rate

  Within 30 days of discharge

• Unplanned 60-Day Readmission Rate

  Within 60 days of discharge

Study Arms (4)

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 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.

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 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients (≥18 years) with a new, histopathologically confirmed diagnosis of a primary gastrointestinal malignancy (e.g., esophageal, gastric, colorectal cancer). These patients were admitted to a single tertiary care center for elective, curative-intent surgical resection between December 2019 and December 2024. The population represents individuals who had not received prior anti-tumor treatments for their current malignancy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third central hospital of Tianjin affiliated Nankai university: lead

Study Sites (1)

The Third Central Hospital of Tianjin

Tianjin, Tianjin Municipality, 300170, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 5, 2025
• Study Start: December 1, 2019
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

CN (1)