Surgery
Conditions
Keywords
carbohydrate, glucose metabolism, surgery, outcome, major elective surgery, urology, hyperglicemia
Brief summary
Postoperative infectious morbidity remain the most frequent, threatening and costly event after major surgery. Maintenance of postoperative euglycemia might be a key factor to prevent such complications and given the preliminary data on the positive effect of carbohydrate load on glucose metabolism it might also be valuable in improving outcome. If this treatment will be proved effective on relevant outcome measure such as rate of infections, it might be used routinely and extensively because preoperative carbohydrates administration is cheap, simple and applicable by everyone in any surgical ward. The aim of the trial is to evaluate if the normalization of blood glucose by means of preoperative oral administration of maltodextrine, in patients candidate to elective major surgery, may be effective in improve surgical morbidity.
Interventions
DIETARY_SUPPLEMENTPREOP
a carbohydrate beverage (total carbohydrates equal to 12.6g/100 mL: 2.1 g monosaccharide, 10.0 g maltodextrine; 240 mOsm/L) in dose of 800 mL
OTHERwater
The control group will receive plain water with the same volume and timing of treatment.
Sponsors
European Institute of Oncology
San Raffaele University Hospital, Italy
University of Siena
University of Pavia
University of Milano Bicocca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* patients candidate for elective major (expected duration \> 2 hrs) abdominal, urologic, and gynecologic surgery
Exclusion criteria
* diagnosis of diabetes mellitus, * baseline plasma glucose level \> 125 mg/dl, * pancreatic resection, * ASA score \> 3, * malnutrition (loss of weight greater than 10%), * emergency surgery, * documented gastro-esophageal reflux, * corticosteroid therapy, * ongoing infection, * pregnancy, * age \< 18 years, * denied written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of postoperative complications | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| rate of patients needing insulin treatment | 4 days |
| rate of total complications | 30 day after surgery |
| rate of patients needing antibiotic therapy | 30 days after surgery |
| rate of reopaeration | 15 days |
| rate of patients needing intensive care treatment | 15 days |
| length of hospital stay | 15 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| At least one postoperative measurement of blood glucose > 140 mL/dL e < 180 | 15 days | — |
| Severity of complications | 30 days | grading according to Clavien |
| Duration of intensive care treatment | 15 days | — |
| Duration of overall complications | 30 days | — |
| Duration of antibiotic therapy | 30 days | — |
| At least one postoperative measurement of blood glucose > 110 mL/dL e < 140 | 15 days | — |
Countries
Italy
Outcome results
None listed