The Effect of Intensive Dietary Education on Nutritional Status After Gastrectomy(SING)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-75
SponsorSamsung Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Dietary education(nutritional counselling)
Other interventionDietary education provided to gastrectomy patients by dietitian.
Treatment groups
358 Participants
are divided into 4 treatment groupsGroup A: SE-STGActive comparator 1 intervention
Group B: IE-STGActive comparator 1 intervention
Group C: SE-TGActive comparator 1 intervention
Group D: IE-TGActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from preoperative weight change at immediate postoperative period in SE and IE groups.
comparison of weight change between the two groups after surgery
Time frame
preoperative, immediate postoperative2
Change from preoperative weight change at postoperaive 1 month in SE and IE groups.
comparison of weight change between the two groups after surgery
Time frame
preoperative, postoperative 1 month3
Change from preoperative weight change at postoperaive 3 months in SE and IE groups.
comparison of weight change between the two groups after surgery
Time frame
preoperative, postoperative 3 months4
Change from preoperative weight change at postoperaive 6 months in SE and IE groups.
comparison of weight change between the two groups after surgery
Time frame
preoperative, postoperative 6 monthsSecondary outcomes
1
Nutritional parameters
measured by Patient-Generated Subjective Global Assessment (PG-SGA; rating A,B,C)
Time frame
preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months2
24hrs dietary recall
calculating kcal \& protein intake by 24hrs dietary recall (questionnaire)
Time frame
preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months3
dietary habits
number of meals, eating speed (questionnaire)
Time frame
preoperative, immediate postoperative, postoperative 1 months, 3 months, 6months, 12 months, 18 months4
Albumin
g/dL
Time frame
preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 monthsSponsors and contacts
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Source ClinicalTrials.gov