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

Obesity | Preoperative Weight Loss | Preoperative Optimization | Non-Bariatric Surgery

The 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 Centre
Kingston, Ontario
Canada

Contact Study Team

Juravinski Hospital
Juravinski Hospital
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Mohit Bhandari, MD PhD

[email protected]
St. Joseph's Healthcare Hamilton
St. Joseph's Healthcare Hamilton
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Cagla Eskicioglu, MD MSc

[email protected]
Hamilton General
Hamilton General
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Mohit Bhandari, MD PhD

[email protected]
Study Sponsored By
McMaster University
Participants Required
More Information
Study ID: NCT05918471