A Randomized Controlled Trial Comparing Postoperative Complication Between Preoperative Oral Nutritional Supplement With Dietary Advice and Conventional Dietary Advice Alone in Patients Undergoing Elective Major Gastrointestinal Surgery
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Mahidol University
- Enrollment
- 268
- Locations
- 1
- Primary Endpoint
- Postoperative complications
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Preoperative oral nutritional supplement
Oral nutritional supplement 500 kcal/day for 14 days and dietary advice
Intervention: Oral nutritional supplement (ONS) (Dietary Supplement)
Conventional treatment
Dietary advice
Outcomes
Primary Outcomes
Postoperative complications
Time Frame: 30 days after operation
Number of complications
Secondary Outcomes
No secondary outcomes reported
Investigators
Narongsak Rungsakulkij
Lecturer
Mahidol University