MedPath

Preoperative Oral Nutritional Supplement vs Conventional Dietary Advice in Major Gastrointestinal Surgery

Not Applicable
Conditions
Surgery--Complications
Nutrition Aspect of Cancer
Interventions
Dietary Supplement: Oral nutritional supplement (ONS)
Registration Number
NCT03315195
Lead Sponsor
Mahidol University
Brief Summary

Surgical outcome is associated the nutritional status of the patients. Perioperative nutritional supplement for malnutritional patient were recommended. There are several guidelines were recommended the perioperative nutrition for malnutrition patients. But in our hospital, there are no consensus guideline applied for the clinical practice. The nutritional supplement was judged by only attending physical This study was conducted to comparing the perioperative nutritional supplement with oral supplement with conventional approach with only dietary advice alone for all patients who undergoing major gastrointestinal surgery.

Detailed Description

The study design is a randomized controlled study. The eligible criteria is all patients who undergoing major gastrointestinal surgery including upper/lower gastrointestinal tract and hepatobiliary and pancratic surgery. After the informed consent are obtained. The patients are randomized into two group (study group and conventional group). The perioperative supplement with oral nutritional support and dietary advice were assigned in the study group. The conventional group were assigned only dietary advice. The blood test and nutritional assessment are performed by investigators in all participants. The participants were assessed two times before the operation (at first assigned and the day before the operation). The duration of nutritional supplement is at least fourteen days.The patient characteristic data, surgical intervention, and postoperative data were collected. The main outcome is the postoperative morbidity and mortality.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
268
Inclusion Criteria
  • age > 18 year
  • undergoing major gastrointestinal surgery
  • able to take oral diet
Read More
Exclusion Criteria
  • unable to take oral diet
  • Gastrointestinal tract insufficiency eg. gastrointestinal obstruction, perforation, malabsorption and peritonitis
  • allergy to milk
  • history of previous nutritional supplement from other source within one months
  • chronic kidney disease (eGFR < 60 ml/min/1.73 m2)
  • Take preoperative supplement less than 14 days
  • Refused or withdraw from the study
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Preoperative oral nutritional supplementOral nutritional supplement (ONS)Oral nutritional supplement 500 kcal/day for 14 days and dietary advice
Primary Outcome Measures
NameTimeMethod
Postoperative complications30 days after operation

Number of complications

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Ramathibodi Hospital

🇹🇭

Bangkok, Thailand

© Copyright 2025. All Rights Reserved by MedPath