Pre-operative Carbohydrate Drink to Preserve Peri-operative Insulin Sensitivity

McGill University Health Centre/Research Institute of the McGill University Health Centre30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Laparoscopic Abdominal Surgery

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

difference in insulin resistance

intra-operative insulin resistance as assessed by glucose infusion rate required to maintain euglycemic state during a hyperinsulinemic euglycemic glucose clamp

Time frame: Intra-operative from beginning of surgical procedure until the end of the procedure

Secondary Outcomes

Comparing the Homeostasis model assessment (HOMA) index at four different time points ( by employing Fasting blood sugar and Plasma Insulin)

Time frame: at 4 time points as follow : on the morning before surgery, first, second and third morning after the surgery

Comparing the preoperative thirst

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.

Time frame: Two times at 2 weeks before surgery (baseline) and immediately before surgery

Comparing the preoperative hunger

Time frame: Two times at 2 weeks before surgery (baseline) and immediately before surgery

Comparing the preoperative well-being

Time frame: Two times at 2 weeks before surgery (baseline) and immediately before surgery

Comparing the preoperative anxiety

Time frame: Two times at 2 weeks before surgery (baseline) and immediately before surgery

Grip strength

will be measured by a hand grip dynamometer

Time frame: Two times at 2 weeks before surgery (baseline) and 2 days after surgery

Time to readiness for discharge (TRD)

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.

Time frame: up to 30 days after surgery

Postoperative infectious complications

Including urinary tract infection, wound infection, intra- or retroperitoneal abscess, pneumonia , sepsis and any other documented infectious complications

Time frame: 30 days after operation

Pre-operative Carbohydrate Drink to Preserve Peri-operative Insulin Sensitivity

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes