The Effect of Intensive Dietary Education on Nutritional Status After Gastrectomy(SING)

Subject 1: subtotal gastrectomy group

subject 2: total gastrectomy group

Objectives:

Primary objective: to evaluate Weight loss difference of simplified dietary education(SE) versus intensive dietary education(IE) for patients after undergoing a gastrectomy

Primary endpoint: Superiority of weight loss difference (%) of IE group between post op 1mo and 12mo

Secondary objectives:

weight loss(%) of each subgroup, nutritional parameters (PG-SGA), Calrorie intake & dietary habits, albumin, hemoglobin, iron panel (TIBC, ferritin), Absolute lymphocyte count(ALC), vit B12, homocysteine, quality of life(QOL) change

• Nutritional parameters (PG-SGA)
• the amount of calorie intake (Kcal, protein) & dietary habits
• Albumin (g/dL)
• Hemoglobin (g/dL)
• Iron panel [TIBC (μg/dL), Ferritin (ng/mL)]
• Absolute lymphocyte count (ALC) (10^3/μL)
• Vitamin B12 (pg/mL)
• Homocysteine (μmol/L)
• Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)

Inclusion criteria

• histologically proven primary gastric adenocarcinoma,
• T1N0, T1N1, T2N0, which are assessed by computed tomography (CT) scan (AJCC 8th classification) and intraoperative surgical staging
• location of primary tumor; antrum, or angle, , lower body or mid body of the stomach
• No evidence of other distant metastasis,
• age ≥ 20 year old, ≤ 75 year old
• no prior or posterior treatment of chemotherapy or radiation therapy against any other malignancies
• adequate organ functions defined as indicated below:

• WBC count: 3000/mm3 ~12,000/mm3,
• > serum Hemoglobin 8.0 g/dL
• > serum Platelet 100 000/mm3,
• < serum AST 100 IU/L,
• <serum ALT 100 IU/L,
• < Total Bilirubin 2.0 mg/dL,
• written signed informed consent

Exclusion criteria

• active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer),
• gastric remnant cancer
• ≥T3, T4 in surgical staging before resection
• N2 or more (number of metastatic lymph nodes ≥3) in CT scan
• histologically rare variants in World Health Organization (WHO) Classification such as Adenosquamous, Hepatoid, Squamous cell, Undifferentiated, neuroendocrine carcinoma and others
• pregnant or breast-feeding women,
• mental disorder(diagnosed with mental disorder on medical record),
• unstable angina or myocardial infarction within 6 months of the trial,
• unstable hypertension,
• diabetes mellitus on insulin,
• severe respiratory disease requiring continuous oxygen therapy,
• previous upper abdominal surgery except laparoscopic cholecystectomy,
• surgical complication