PReoperative Very Low Energy Diets for Obese PAtients Undergoing Non-bariatric Surgery
Obesity | Preoperative Weight Loss | Preoperative Optimization | Non-Bariatric SurgeryThe PREPARE Pilot randomized controlled trial (RCT) is a multi-center, parallel, blinded RCT that aims to assess the feasibility of a full RCT comparing preoperative very low energy diets (VLEDs) to standard of care prior to elective non-bariatric surgery for obese patients in terms of overall 30-day postoperative morbidity. Adult patients with body mass indices (BMIs) greater than 30 kg/m2 will be randomized 1:1 to receive 3-weeks of preoperative VLED plus preoperative weight loss counselling or preoperative weight loss counselling alone. This trial will enroll patients to assess recruitment, compliance, and follow-up completion to assess the feasibility of a full RCT powered to assess for differences in 30-day postoperative between VLEDs and standard of care arms.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation 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.
Study Location
Kingston Health Sciences Centre
Kingston Health Sciences CentreKingston, Ontario
Canada
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Juravinski Hospital
Juravinski HospitalHamilton, Ontario
Canada
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Hamilton General
Hamilton GeneralHamilton, Ontario
Canada
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St. Joseph's Healthcare Hamilton
St. Joseph's Healthcare HamiltonHamilton, Ontario
Canada
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- Study Sponsored By
- McMaster University
- Participants Required
- More Information
- Study ID:
NCT05918471