Pre-operative Carbohydrate Drink to Preserve Peri-operative Insulin Sensitivity
- Conditions
- Laparoscopic Abdominal Surgery
- Interventions
- Dietary Supplement: complex carbohydrate drinkDietary Supplement: simple carbohydrate drink
- Registration Number
- NCT02673502
- Lead Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- At least 18 years of age
- Planned laparoscopic partial colon resection for non-metastatic neoplastic or benign disease (including right, transverse, left or sigmoid))
- HbA1c less than or equal to 5.7%
- Not receiving any kind of glucose lowering medication.
- Are already diagnosed with diabetes or pre diabetes (HbA1c > 5.7%)
- Are pre-diabetic receiving glucose lowering intervention (any glucose lowering medication)
- 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)
- Will undergo extended resection of adjacent organs
- Non-elective operations
- New stoma created
- Have conditions precluding participation in the ERAS pathway (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis)
- 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).
- 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)
- Have received steroids for longer than 30 days
- Have poor English or French comprehension.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description complex carbohydrate drink complex 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. simple carbohydrate drink simple 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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.
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
Trial Locations
- Locations (1)
Montreal General Hospital
🇨🇦Montreal, Quebec, Canada