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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03315195
Enrollment
268
Registered
2017-10-20
Start date
2017-11-25
Completion date
2022-03-31
Last updated
2020-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition Aspect of Cancer, Surgery--Complications

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.

Interventions

ONS supplement by 500 kcal/day for 14 days

Sponsors

Ramathibodi Hospital
CollaboratorOTHER
Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative complications30 days after operationNumber of complications

Countries

Thailand

Contacts

Primary ContactNattapanee Sukphol, MD.
nattapanee_benz@hotmail.com+6622011527
Backup ContactNarongsak Rungsakulkij, MD.
narongsak.run@mahidol.ac.th+6622011527

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026