A Randomized Clinical Trial of Simplified Dietary Education Versus Intensive Dietary Education on Nutritional Status After Gastrectomy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Samsung medical center
RECRUITING
Seoul
Contact Information
Primary
Jae-Moon Bae, MD, Ph.D
jmoon.bae@samsung.com
82-2-3410-0252
Backup
Aron Lee, RD
82-2-3410-0498
Time Frame
Start Date: 2021-03-09
Estimated Completion Date: 2025-10
Participants
Target number of participants: 358
Treatments
Active_comparator: SE-STG
simplified dietary education arm in subtotal gastrectomy group.
Active_comparator: IE-STG
intensive dietary education arm in subtotal gastrectomy group
Active_comparator: SE-TG
simplified dietary education arm in total gastrectomy group.
Active_comparator: IE-TG
intensive dietary education arm in total gastrectomy group
Related Therapeutic Areas
Sponsors
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov