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NCT Number: NCT07104175

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Third Central Hospital of Tianjin

Tianjin, Tianjin Municipality, 300170, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of Postoperative Complications

    Time frame: Up to 30 days post-surgery

    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.

Secondary outcomes

  1. Length of Hospital Stay

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

    The total duration of the index hospitalization, measured from the date of admission to the date of discharge.

  2. Intensive Care Unit (ICU) Admission Rate

    Time frame: Up to 30 days post-surgery

    The percentage of patients admitted to the ICU at any point during their postoperative hospital stay.

  3. Unplanned 30-Day Readmission Rate

    Time frame: Within 30 days of discharge

    The percentage of patients who had an unplanned hospital readmission for any reason.

  4. Unplanned 60-Day Readmission Rate

    Time frame: Within 60 days of discharge

    The percentage of patients who had an unplanned hospital readmission for any reason.

Sponsors and collaborators

Lead sponsor

Third central hospital of Tianjin affiliated Nankai university

Network

Registry information

Official study title

Value Analysis of Preoperative Nutritional Risk Screening 2002 (NRS2002) and Global Leadership Initiative on Malnutrition (GLIM) Screening in Predicting Postoperative Complications in Patients With Gastrointestinal Malignancies

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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