Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04798820
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2021-03-05
Brief Title:
The Effect of Intensive Dietary Education on Nutritional Status After GastrectomySING
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
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 cancerHowever 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 stomachWeight 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 educationSE versus intensive dietary educationIE 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 countALC vit B12 homocysteine quality of lifeQOL change
1 Nutritional parameters PG-SGA
2 the amount of calorie intake Kcal protein dietary habits
3 Albumin gdL
4 Hemoglobin gdL
5 Iron panel TIBC μgdL Ferritin ngmL
6 Absolute lymphocyte count ALC 103μL
7 Vitamin B12 pgmL
8 Homocysteine μmolL
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 educationSE versus intensive dietary educationIE 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 countALC vit B12 homocysteine quality of lifeQOL change
1 Nutritional parameters PG-SGA
2 the amount of calorie intake Kcal protein dietary habits
3 Albumin gdL
4 Hemoglobin gdL
5 Iron panel TIBC μgdL Ferritin ngmL
6 Absolute lymphocyte count ALC 103μL
7 Vitamin B12 pgmL
8 Homocysteine μmolL
9 Quality of life of the patients in terms of European quality of life questionnaire EQ-5D
Study Oversight
Has Oversight DMC:
None
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?:
None