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

Mahidol University

Status

Unknown

Conditions

Surgery--Complications

Nutrition Aspect of Cancer

Treatments

Dietary Supplement: Oral nutritional supplement (ONS)

Study type

Interventional

Funder types

Other

Identifiers

NCT03315195

ID 06-60-72

Details and patient eligibility

About

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.

Full 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.

Enrollment

268 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age > 18 year
undergoing major gastrointestinal surgery
able to take oral diet

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