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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Intervention | Experimental | Open Sleeve gastrectomy procedure will be performed immediately following liver transplantation (as a single surgery) or within 2 weeks of transplantation (as a second open surgery) |
|
| No Surgical Intervention | No Intervention | Liver transplantation will proceed as per routine practice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleeve gastrectomy | Procedure | Open sleeve gastrectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| morbid obesity | rate of morbid obesity defined as BMI greater than or equal to 35 | 12 months post-liver transplant |
| Measure | Description | Time Frame |
|---|---|---|
| mortality | patient mortality | 12 months post-transplant |
| surgical morbidity | rate of surgical morbidity | 12 months post-transplant |
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Inclusion Criteria:
Exclusion Criteria:
• Listed for re-transplantation, or transplantation of another organ (eg. kidney).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin Winter, BSc | Contact | 416-340-4800 | 6093 | erin.winter@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| David R Grant, M.D. | University Health Network, Toronto | Principal Investigator |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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1:1 randomization to group a or group b
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| surgical morbidity | rate of surgical morbidity | 3 months post-transplant |
| mortality | patient mortality | 3 months post-transplant |
| change in weight | weight loss or gain as percentage of estimated "dry" weight at transplantation | 12 months |
| surgical complications | rate of surgical complications | 12 months |
| sleep apnea | percentage of participants in each group requiring BiPAP or CPAP for treatment of sleep apnea | 12 months post-transplantation |
| hypertension | percentage of participants in each group requiring treatment of hypertension | 12 months post-transplantation |
| diabetes | percentage of participants in each group requiring medical treatment of diabetes | 12 months post-transplantation |
| hyperlipidemia | percentage of participants in each group requiring medical treatment of elevated lipids | 12 months post-transplantation |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |