Clinical trial NCT06018246: Nutritional Risk Screening Nutritional Support Gastrointestinal Cancer
Official title: Effects of Different Nutritional Support Modes Based on Nutritional Risk Screening on Postoperative Nutritional Status of Patients With Gastrointestinal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Cancer
Lead sponsor: The First Affiliated Hospital of Shanxi Medical University
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 624
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Nutritional risk screening 2002
timeFrame: baseline and through study completion, an average of 1 year
measure: Patient-generated subjective nutrition assessment
timeFrame: baseline and through study completion, an average of 1 year
Secondary outcomes:
measure: Dietary energy intake
timeFrame: 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
measure: Dietary protein intake
timeFrame: 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
measure: Nutrient energy intake
timeFrame: 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
measure: Nutrient protein intake
timeFrame: 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
measure: Prealbumin
timeFrame: 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
measure: Albumin
timeFrame: 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
measure: Hemoglobin
timeFrame: 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
measure: BMI
timeFrame: 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
measure: Fat-free body weight
timeFrame: 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
measure: Grip strength
timeFrame: 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
measure: Walking time
timeFrame: 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
Other outcomes:
measure: Adverse reaction
timeFrame: 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
Locations:
city: Taiyuan
country: China
facility: Huang He
state: Shanxi
Study officials:
affiliation: The First Affiliated Hospital of Shanxi Medical University
name: He Huang, doctor's degree
role: STUDY_DIRECTOR
References: