Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT04798820
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2021-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Intensive Dietary Education on Nutritional Status After Gastrectomy(SING)
Sponsor:
Samsung Medical Center
Organization:
Study Overview
Official Title:
A Randomized Clinical Trial of Simplified Dietary Education Versus Intensive Dietary Education on Nutritional Status After Gastrectomy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SING
Brief Summary:
Radical gastrectomy has been known as the most effective treatment of curable gastric cancer.However, there is a high risk of malnutrition and weight loss after a gastrectomy which may be attributed to inadequate oral consumption, malabsorption and loss of the reservoir function of the stomach.Weight loss has been regarded as an independent risk factor for postoperative mortality and morbidity and It is also closely associated with a quality of life after surgery. No specific surgical technique has been proved to be effective in reducing postoperative weight loss and it seems like that dietary education and consultation is the best way to minimize weight loss in gastrectomy patients in clinical setting. In this regard, the investigators performed a retrospective pilot study to identify the effect of routinely performed (simplified) dietary education on nutritional status after gastrectomy, but it revealed that the effect of simplified dietary education on weight loss was not clear and the result implies that more intensive dietary education may be necessary after gastrectomy. The aim of this randomized controlled trial (RCT) is to elucidate the effect of intensive dietary education on nutritional status after gastrectomy in comparison with simplified dietary education.
Detailed Description:
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
1. Nutritional parameters (PG-SGA)
2. the amount of calorie intake (Kcal, protein) \& dietary habits
3. Albumin (g/dL)
4. Hemoglobin (g/dL)
5. Iron panel \[TIBC (μg/dL), Ferritin (ng/mL)\]
6. Absolute lymphocyte count (ALC) (10\^3/μL)
7. Vitamin B12 (pg/mL)
8. Homocysteine (μmol/L)
9. Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)
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
1. Nutritional parameters (PG-SGA)
2. the amount of calorie intake (Kcal, protein) \& dietary habits
3. Albumin (g/dL)
4. Hemoglobin (g/dL)
5. Iron panel \[TIBC (μg/dL), Ferritin (ng/mL)\]
6. Absolute lymphocyte count (ALC) (10\^3/μL)
7. Vitamin B12 (pg/mL)
8. Homocysteine (μmol/L)
9. Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: