Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04607057
Status:
UNKNOWN
Last Update Posted:
2021-09-24
First Post:
2020-10-12
Brief Title:
Supplemental Parenteral Nutrition During Postgastrectomy in Nutritionally at Risk Patient
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
The Effect of Postoperative Supplemental Parenteral Nutrition SPN in Gastric Cancer Patients Who Underwent Gastrectomy A Multicenter Prospective Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
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:
SUPPORT
Brief Summary:
If a patient undergoes gastrectomy which is a kind of major abdominal operation heshe loses more than 5 of hisher 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 2550 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
According to Nutrition Risk Screening NRS 2002 moderate malnutrition is defined as the state that the patient orally intakes 2550 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
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