NCT04607057

Supplemental Parenteral Nutrition During Postgastrectomy in Nutritionally at Risk Patient

The Effect of Postoperative Supplemental Parenteral Nutrition (SPN) in Gastric Cancer Patients Who Underwent Gastrectomy: A Multicenter Prospective Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

* If a patient undergoes gastrectomy, which is a kind of major abdominal operation, he/she loses more than 5% of his/her body weight in 2 months after surgery. This point is one of the criteria of 'risk of malnutrition' according to Nutrition Risk Screening (NRS 2002) and the patient who corresponds to this criterion needs nutritional support. * According to Nutrition Risk Screening (NRS 2002), moderate malnutrition is defined as the state that the patient orally intakes 25\~50% of recommended requirements; severe malnutrition is less than 25%. * Meanwhile, when oral nutrition support was provided to patients after gastric cancer surgery, the patients' average daily intake during the first three months was about a half of the recommended requirements. * Putting together the facts i) that the patient underwent major abdominal operation, ii) that the weight loss rate exceeded 5% for two months, iii) that the average daily intake of patients during the first three months was about half of the recommended amount, the patients are eligible to be classified as a group who require nutritional support according to NRS 2002. Therefore, it is intended to verify the efficacy and safety of supplemental parenteral nutrition by comparing Arm A, who are provided oral intake with supplemental parenteral nutrition, Arm B, who are provided oral intake only after curative gastric cancer surgery.

Detailed description

With at least 5 days of supplemental parenteral nutrition, we expect minimized body weight loss, favorable blood test result, eligibility for chemotherapy compliance, increased quality of life (QoL), decreased infection rate, decreased hospital stay, and decreased mortality.

Conditions

• Gastric Cancer
• Gastrectomy
• Malnutrition

Interventions

Type	Name	Description
DRUG	Parenteral Nutrition Solutions	* Day0 : fasting(NPO) + crystalloid fluid * POD#1 : Keep fasting, then start sips of water in the evening + crystalloid fluid * POD#2 : Semifluid diet (SFD) + crystalloid fluid * POD#3 : Semifluid diet (SFD) + PN * POD#4-7: Soft blended diet (SBD) + PN

Timeline

• Start date: 2020-12-22
• Primary completion: 2022-10-30
• Completion: 2022-10-30
• First posted: 2020-10-28
• Last updated: 2021-09-24

Locations

1 site across 1 country: South Korea