Nutritional Risk Screening Nutritional Support Gastrointestinal Cancer

Shanxi Medical University

Status: Completed

Conditions: Gastrointestinal Cancer

Treatments: Dietary Supplement: Malnutrition five-step treatment model + conventional nutritional intervention; Other: Conventional nutritional intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06018246

2022HLL003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 624 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion Criteria:

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

• Exclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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624 participants in 2 patient groups

Intervention Group

Experimental group

Description:

1. Before operation：The patients' dietary intake was assessed by a 24-hour dietary review by a professional dietitian.According to the diet of the patients, the intervention was carried out by a professional nutritionist according to the five-step treatment mode of malnutrition.If the food intake cannot meet 60% of the daily requirement, the previous step of treatment is used, and it is adjusted at any time according to the situation of the patient. 2. After operation:Same as control group. 3. Out-of-hospital: Same as before operation. 4. Strengthening Health Education and psychological intervention:Dietitians need to strengthen health education and communicate with patients during the implementation of nutrition intervention.For patients who actively cooperate with treatment, dietitians can give encouragement. 5. Exercise Instruction:After the operation, according to the tolerance, the dietitian can instruct the patient to take a certain time walking every day.

Treatment:

Dietary Supplement: Malnutrition five-step treatment model + conventional nutritional intervention

Control Group

Other group

Description:

Routine nutrition support in department.Nutritionists will give patients routine parenteral nutrition support via peripheral or central vein 0-48 hours after surgery and then start enteral nutrition support 48-72 hours after surgery.Patients were initially given half of their enteral nutrition and the rest was supplemented with parenteral nutrition.After adaptation, the patient stopped parenteral nutrition and all nutrition came from enteral nutrition.After the patient's gastrointestinal function gradually recovered, the enteral nutrition could gradually decrease.At this time, nutritionists can let the patient eat some light liquid food, but pay attention to eating a small amount of multiple times.After adaptation, patients can gradually transition from liquid diet to semi-liquid diet.We will educate patients and their families about diet and encourage them to eat more high-quality protein-rich foods.

Treatment:

Other: Conventional nutritional intervention