Preoperative Oral Nutritional Supplement vs Conventional Dietary Advice in Major Gastrointestinal Surgery
- Conditions
- Surgery--ComplicationsNutrition 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
- age > 18 year
- undergoing major gastrointestinal surgery
- able to take oral diet
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Preoperative oral nutritional supplement Oral nutritional supplement (ONS) Oral nutritional supplement 500 kcal/day for 14 days and dietary advice
- Primary Outcome Measures
Name Time Method Postoperative complications 30 days after operation Number of complications
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ramathibodi Hospital
🇹ðŸ‡Bangkok, Thailand