PReoperative Very Low Energy Diets for Obese PAtients Undergoing Non-bariatric Surgery (PREPARE)
Obesity, Non-Bariatric Surgery, Preoperative Weight Loss
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria: Older than 18 years of age BMI of greater than 30 kg/m2 Undergoing major elective non-bariatric surgery. Major surgery is defined as any operation performed under general anesthesia requiring a skin incision extending beyond the subcutaneous tissue. Exclusion Criteria: Undergoing bariatric surgery Undergoing neurologic surgery Undergoing urgent or emergent surgery Recently diagnosed myocardial infarction or unstable angina (i.e., within past six months) Diagnosed moderate-to-severe renal dysfunction (i.e., eGFR less than 30mL/min/1.73m2) Diagnosed severe liver dysfunction (i.e., cirrhosis, portal hypertension, hepatic encephalopathy, hepatorenal syndrome) Recently diagnosed alcohol or drug use disorders (i.e., excessive use of substance within past six months) Experienced a recent episode of gout (i.e., within past six months) Medical history of porphyria; (10) Known allergy to any Optifast ingredient Enrolled in other prospective studies with similar interventions and/or outcomes. Co-enrollment may be deemed appropriate if the steering committees of the respective trials review the details of participation. Pregnant or breastfeeding women Patients unable to provide informed consent.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Very Low Energy Diet + Standard Counselling
Standard Counselling Alone
All patients in the intervention group will receive standard patient counselling on weight loss and an active VLED protocol. The preoperative VLED protocol will utilize Optifast 900, a commercially available weight loss product sold by Nestlé Health Sciences. Optifast 900 is designed as a high-protein, low-carbohydrate, and low-fat meal replacement with complete micronutrient composition. Patients will receive a three-week supply. They will be instructed to consume four packets daily. This provides a total energy intake of 900 kcal. Patients will also be able to consume up to 2 cups of low-calorie vegetables per day along with the meal replacement product. They will be provided with a handout containing specific instructions. Patients will keep self-report diaries of their dietary intake and activity levels.
The control group patients will receive standard counselling for weight loss without prescription of a specific preoperative weight loss intervention, as this is meant to be a pragmatic trial. Currently, there are no standardized interventions aimed at optimizing obese patients prior to undergoing non-bariatric surgery. Briefly, counselling will consist of the surgeon, at the time of the preoperative clinic visit, discussing weight loss strategies such as decreased caloric intake and increased physical activity. Patients will not receive prescriptions for preoperative VLEDs, any other weight loss supplement, or any physical activity intervention aimed at promoting weight loss prior to surgery. Patients will keep self-report diaries of their dietary intake and activity levels.