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Clinical Trials/NCT06018246
NCT06018246
Completed
Not Applicable

Effects of Different Nutritional Support Modes Based on Nutritional Risk Screening on Postoperative Nutritional Status of Patients With Gastrointestinal Cancer

The First Affiliated Hospital of Shanxi Medical University1 site in 1 country624 target enrollmentJuly 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastrointestinal Cancer
Sponsor
The First Affiliated Hospital of Shanxi Medical University
Enrollment
624
Locations
1
Primary Endpoint
Nutritional risk screening 2002
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The goal of this clinical trial was to compare the effects of different nutritional support methods based on nutritional risk screening on postoperative nutritional status in patients with gastrointestinal tumors.The main question it aims to answer is that different types of nutrition can improve the nutritional status of patients with different nutritional status;Long-term dietary interventions for patients with poor nutrition can make cancer patients better able to tolerate surgery and chemotherapy and improve their quality of life.The intervention group received nutrition + exercise + psychological intervention upon admission, routine parenteral and enteral nutrition support after operation, and continued nutrition + exercise + psychological intervention after discharge.The control group received routine parenteral nutrition support in the department after surgery, and the patients and their families were given diet education during hospitalization.

Detailed Description

Purpose: The investigators conducted nutritional risk screening for patients with gastrointestinal tumors, gave different nutritional support methods to patients with different nutritional status, and analyzed the changes of various nutritional indexes of patients before and after nutritional intervention. Methods: A total of 302 patients with gastrointestinal tumors admitted to the First Hospital of Shanxi Medical University from July 2021 to June 2023 were selected.All patients underwent nutritional risk screening after admission and were divided into intervention group (NRS2002≥3 and PG=SGA≥4, n=204) and control group (NRS2002 \< 3 or PG=SGA \< 4 , n=98) according to the screening results.Different nutritional interventions were given to analyze the changes of NRS-2002 and PG-SGA scores between the two groups before and after propensity score matching, and compare the changes of dietary energy, dietary protein, total energy, total protein, body mass index (BMI), fat-free weight, walking time, grip strength and other nutritional indicators (hemoglobin, albumin, prealbumin) between the two groups.The effects of disease type and age on the results were compared by stratified analysis.

Registry
clinicaltrials.gov
Start Date
July 20, 2021
End Date
July 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
The First Affiliated Hospital of Shanxi Medical University
Responsible Party
Principal Investigator
Principal Investigator

Huang He

Chief physician of gastrointestinal surgery and Section chief of Medical Services Division

The First Affiliated Hospital of Shanxi Medical University

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years;
  • The first pathological diagnosis was gastric or colorectal cancer and radical resection of malignant tumor was performed;
  • Conscious, able to read, write and understand the study;
  • Sign informed consent and participate in this study voluntarily.

Exclusion Criteria

  • Patients with malignant tumors at other sites;
  • Patients undergoing neoadjuvant chemotherapy before surgery;
  • Anastomotic fistula, anastomotic obstruction, gastroparesis and other serious complications occurred after operation;
  • There are mental disorders, psychological disorders;
  • Patients who did not cooperate to complete the full intervention or follow-up records were missing;
  • Patients with missing baseline data and nutritional risk screening results.

Outcomes

Primary Outcomes

Nutritional risk screening 2002

Time Frame: baseline and through study completion, an average of 1 year

Nutritional risk screening scale:The maximum score of NRS2002 is 7 points and the minimum score is 0 points. A score of NRS2002≥3 indicates the presence of nutritional risk, and nutritional support programs should be developed in combination with clinical practice. A score of NRS2002 \< 3 indicates no nutritional risk, and a review is performed 1 week later.

Patient-generated subjective nutrition assessment

Time Frame: baseline and through study completion, an average of 1 year

Nutritional risk screening scale:0-1 score, no intervention is required at this time, regular regular nutritional status score. 2 to 3 points, the nutritionist, nurse or clinician to educate the patient and family, and appropriate drug intervention for symptoms and laboratory tests. 4-8 points, requiring nutritional intervention and symptomatic treatment. A score of ≥9 indicates an urgent need for symptomatic treatment and appropriate nutrient support.

Secondary Outcomes

  • Nutrient protein intake(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • Dietary energy intake(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • Dietary protein intake(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • Nutrient energy intake(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • Hemoglobin(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • Prealbumin(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • Walking time(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • Albumin(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • BMI(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • Fat-free body weight(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)
  • Grip strength(baseline 、7 days after admission、1 month after admission、2 month after admission、4 month after admission and through study completion, an average of 1 year)

Study Sites (1)

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