Laparoscopic Abdominal Surgery
Conditions
Keywords
Carbohydrate drink, Post operative complication, insulin resistance, Fasting blood glucose
Brief summary
Enhanced Recovery after Surgery (ERAS) pathways include multiple evidence-based interventions delivered throughout the peri-operative period that aim to attenuate the surgical stress response and support rapid physiologic and functional recovery.A key element of the ERAS pathway is the administration of a clear carbohydrate-rich beverage 2-3 h before surgery in order to keep the patient in a fed state rather than a fasted state when they go to the operating room. The aim of the current study is to investigate the impact of a drink containing simple carbohydrate on attenuating surgical stress induced insulin resistance in patients undergoing major laparoscopic abdominal surgery, compared to drinks containing maltodextrin.
Interventions
DIETARY_SUPPLEMENTsimple carbohydrate drink
Patients will ingest 400 ml of the simple carbohydrate drink consisting of commercial orange juice without pulp which contains 50 grams fructose/galactose 2 hours before surgery.
DIETARY_SUPPLEMENTcomplex carbohydrate drink
Patients will ingest 400 ml of the complex carbohydrate drink containing 50 grams of maltodextrin powder in water ( orange food color and artificial orange flavor have been added to the drink) 2 hours before surgery
Sponsors
Mitacs
Medtronic - MITG
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years of age 2. Planned laparoscopic partial colon resection for non-metastatic neoplastic or benign disease (including right, transverse, left or sigmoid)) 3. HbA1c less than or equal to 5.7% 4. Not receiving any kind of glucose lowering medication.
Exclusion criteria
1. Are already diagnosed with diabetes or pre diabetes (HbA1c \> 5.7%) 2. Are pre-diabetic receiving glucose lowering intervention (any glucose lowering medication) 3. Have renal or liver dysfunction (serum creatinine above 1.4 mg/dL in women and 1.5 mg/dL in men, bilirubin \>2.9 mg/dL) 4. Will undergo extended resection of adjacent organs 5. Non-elective operations 6. New stoma created 7. Have conditions precluding participation in the ERAS pathway (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis) 8. Have conditions requiring preoperative fasting: documented gastroparesis, patient on metoclopramide and/or domperidone, achalasia, dysphagia (any difficulty with swallowing), or Fluid restriction (e.g. dialysis, pulmonary oedema, congestive heart failure). 9. Have cardiac abnormalities, severe end-organ disease such as cardiac failure (New York Heart Association classes III-IV), chronic obstructive pulmonary disease (documented by abnormal pulmonary function test), morbid obesity (BMI \>40 kg/m2), anemia (hematocrit \< 30 %, hemoglobin \<100g/L, albumin \< 25mg/dl) 10. Have received steroids for longer than 30 days 11. Have poor English or French comprehension.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| difference in insulin resistance | Intra-operative from beginning of surgical procedure until the end of the procedure | intra-operative insulin resistance as assessed by glucose infusion rate required to maintain euglycemic state during a hyperinsulinemic euglycemic glucose clamp |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparing the preoperative thirst | Two times at 2 weeks before surgery (baseline) and immediately before surgery | Patients will complete a standard 10mm visual analogue scale (VAS) for each of the measures by marking the level on the scale at baseline in the pre-op clinic visit and once more immediately before surgery. |
| Comparing the preoperative hunger | Two times at 2 weeks before surgery (baseline) and immediately before surgery | Patients will complete a standard 10mm visual analogue scale (VAS) for each of the measures by marking the level on the scale at baseline in the pre-op clinic visit and once more immediately before surgery. |
| Comparing the preoperative well-being | Two times at 2 weeks before surgery (baseline) and immediately before surgery | Patients will complete a standard 10mm visual analogue scale (VAS) for each of the measures by marking the level on the scale at baseline in the pre-op clinic visit and once more immediately before surgery. |
| Comparing the Homeostasis model assessment (HOMA) index at four different time points ( by employing Fasting blood sugar and Plasma Insulin) | at 4 time points as follow : on the morning before surgery, first, second and third morning after the surgery | — |
| Grip strength | Two times at 2 weeks before surgery (baseline) and 2 days after surgery | will be measured by a hand grip dynamometer |
| Time to readiness for discharge (TRD) | up to 30 days after surgery | Previously described criteria to determine the time to readiness for discharge after colorectal surgery will be used . These criteria include tolerance of oral intake, recovery of lower gastro intestinal function, achieving adequate pain control, ability to mobilize and perform self-care and clinical/lab results showing no complications or untreated medical problems. |
| Postoperative infectious complications | 30 days after operation | Including urinary tract infection, wound infection, intra- or retroperitoneal abscess, pneumonia , sepsis and any other documented infectious complications |
| Comparing the preoperative anxiety | Two times at 2 weeks before surgery (baseline) and immediately before surgery | Patients will complete a standard 10mm visual analogue scale (VAS) for each of the measures by marking the level on the scale at baseline in the pre-op clinic visit and once more immediately before surgery. |
Countries
Canada
Outcome results
None listed