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NCT Number: NCT06018246

Nutritional Risk Screening Nutritional Support Gastrointestinal Cancer

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.

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Key information

Conditions

Gastrointestinal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huang He

Taiyuan, Shanxi, 045300, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

  • 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.

Treatment and study plan

Malnutrition five-step treatment model + conventional nutritional intervention

Dietary Supplement
  • Before operation：Same as arm description.
  • After operation:Same as control group.
  • Out-of-hospital: Same as before operation.
  • 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.
  • Exercise Instruction:After the operation, according to the tolerance, the dietitian can instruct the patient to take a certain time walking every day, gradually increase the patient's muscle endurance and improve the body resistance.

Conventional nutritional intervention

Other

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.

Primary outcomes

  1. 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.

  2. 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

  1. Dietary energy intake

    Time frame: 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

    The 24-hour dietary review method was used to investigate the diet of the patients in the first 24 hours, and all the foods were converted into the energy value of the foods, and the dietary energy intake of the patients was calculated by adding.

  2. Dietary protein intake

    Time frame: 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

    The 24-hour dietary review method was used to investigate the diet of the patients in the first 24 hours, and the protein amount provided by each food was recorded, and the dietary protein intake of the patients was calculated by adding.

  3. Nutrient energy intake

    Time frame: 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

    The nutritional energy provided by oral nutrition, enteral nutrition and parenteral nutrition was recorded through inquiry and inquiry of nursing records.

  4. Nutrient protein intake

    Time frame: 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

    The nutritional proteins provided by oral nutrition, enteral nutrition and parenteral nutrition were recorded through inquiry and inquiry of nursing records.

  5. Prealbumin

    Time frame: 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

    Laboratory indicators on nutrition

  6. Albumin

    Time frame: 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

    Laboratory indicators on nutrition

  7. Hemoglobin

    Time frame: 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

    Laboratory indicators on nutrition

  8. BMI

    Time frame: 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

    Dietitians use a body fat scale to measure a patient's weight.When measuring the patient's weight, the body fat scale should be placed on a horizontal, firm floor.The patient takes off shoes and socks and wears light clothes.The patient then stood on the scale, keeping his body naturally upright.The patient's arms should be naturally drooped and relaxed at the sides of the body.Each weight measurement should be set at the same time.The dietitian uses a height meter to measure the patient's height.Weight and height will be combined to report BMI in kg/m^2.

  9. Fat-free body weight

    Time frame: 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

    Dietitians use a body fat scale to measure a patient's fattened weight.When measuring the patient's weight without fat, the body fat scale should be placed on a level, firm floor.The patient takes off shoes and socks and wears light clothes.The patient then stood on the scale, keeping his body naturally upright.The patient's arms should be naturally drooped and relaxed at the sides of the body.The weight loss should be measured at the same time each time.

  10. Grip strength

    Time frame: 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

    A dietitian uses a grip dynamometer to measure a patient's grip strength.When grip strength is measured, the patient's hands naturally droop and no other hand movements can be seen.Dietitians advise patients to measure their grip strength as best they can.The patient is tested on both hands, usually three times with each hand, and an average is taken.

  11. Walking time

    Time frame: 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

    The patients were asked about their daily walking time.

Other outcomes

  1. Adverse reaction

    Time frame: 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

    After the clinician and dietitian judge the occurrence of adverse reactions, the types of adverse reactions are recorded.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Shanxi Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2023
Registry last updated
Aug 30, 2023

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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