Complications associated with excess weight (hypertension, coronary artery disease and diabetes) have become major causes of morbidity and mortality after liver transplantation (LT). To ensure excellent long-term outcomes with LT it is critically important to understand the best strategies to minimize obesity and its associated complications in our patients. Weight loss can be achieved through dieting and exercise, but most patients are unable to maintain the weight loss. In the general population, bariatric surgery is much more effective than medical treatment for permanent weight loss and prevention or reduction of obesity-associated complications. The purpose of this study is to determine the safety and effectiveness of performing sleeve gastrectomy (SG) procedure in the early post-LT period in obese patients. The patient population for this study will be anyone listed for liver transplantation at Toronto General Hospital (University Health Network, Toronto, ON, Canada) and meeting the current standard criteria for bariatric surgery (BMI\>40, or BMI\>35 with at least 1 obesity-related complication).This study will randomly assign eligible participants to one of two groups (1:1). Patients in group 1 will receive standard lifestyle/diet counselling while patients in group 2 will undergo SG-specific counselling prior to transplant and the SG procedure within 2 weeks of LT (if safe to do so). All participants will be followed for 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Open sleeve gastrectomy
morbid obesity
rate of morbid obesity defined as BMI greater than or equal to 35
Time frame: 12 months post-liver transplant
mortality
patient mortality
Time frame: 12 months post-transplant
surgical morbidity
rate of surgical morbidity
Time frame: 12 months post-transplant
surgical morbidity
rate of surgical morbidity
Time frame: 3 months post-transplant
mortality
patient mortality
Time frame: 3 months post-transplant
change in weight
weight loss or gain as percentage of estimated "dry" weight at transplantation
Time frame: 12 months
surgical complications
rate of surgical complications
Time frame: 12 months
sleep apnea
percentage of participants in each group requiring BiPAP or CPAP for treatment of sleep apnea
Time frame: 12 months post-transplantation
hypertension
percentage of participants in each group requiring treatment of hypertension
Time frame: 12 months post-transplantation
diabetes
percentage of participants in each group requiring medical treatment of diabetes
Time frame: 12 months post-transplantation
hyperlipidemia
percentage of participants in each group requiring medical treatment of elevated lipids
Time frame: 12 months post-transplantation
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