PReoperative Very Low Energy Diets for Obese PAtients Undergoing Non-bariatric Surgery

Launched by MCMASTER UNIVERSITY · Jun 23, 2023

Keywords

ClinConnect Summary

The PREPARE Pilot clinical trial is studying how a very low energy diet (VLED) before surgery affects recovery for obese patients undergoing major non-bariatric surgery. The trial will compare two groups of participants: one group will follow a very low energy diet for three weeks along with weight loss counseling, while the other group will only receive weight loss counseling. The goal is to see if the diet helps reduce complications after surgery within the first 30 days.

To participate, you need to be over 18 years old, have a body mass index (BMI) greater than 30, and be scheduled for a major elective surgery, which means an operation that requires general anesthesia and involves a significant incision. The trial is currently recruiting participants. If you join, you can expect to follow a specific diet plan and receive guidance on weight loss before your surgery. This trial is important because it aims to find ways to improve recovery for obese patients, ensuring safer surgical outcomes.

Gender

ALL

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.