Sleeve Gastrectomy for Morbid-Obesity Sequelae After Transplantation: A Randomized Controlled Trial Comparing Sleeve Gastrectomy Following Liver Transplantation to No Surgical Intervention in Patients With Morbid Obesity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- morbid obesity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •actively listed for liver transplantation at University Health Network
- •BMI at screening of a) >40; or b) BMI >35 and 1 obesity-related complication [diabetes (defined as hyperglycemia requiring medication(s) for control), hypertension (defined as a persistently elevated systolic pressure greater than 140 mmHg and/or requiring medication(s) for control), hypercholesterolemia (defined as elevated lipids requiring medication for control)] OR a diagnosis of Non Alcoholic Fatty Liver Disease (defined as the presence of a fatty liver on imaging without a secondary cause such as alcohol abuse) or Non Alcoholic Steatohepatitis
- •upper endoscopy showing no contraindications to a sleeve gastrectomy procedure
排除标准
- •• Listed for re-transplantation, or transplantation of another organ (eg. kidney).
- •Previous bariatric surgery.
- •Contraindication to undergoing sleeve gastrectomy such as severe gastroesophageal reflux disease or Barrett's Esophagus
- •MELD (Model End-Stage Liver Disease) score > 35 at the time of transplantation
- •Presence of any condition that in the opinion of the investigator(s) could compromise the patient's ability to comply with study procedures
- •Patients with a BMI <32 at transplant or having weight loss of 20% or more (pre-transplant estimated dry body weight compared to estimated dry body weight at screening)
- •Presence of any other condition that, in the opinion of the investigator(s), could compromise the patient's ability to safely undergo, or benefit from, the SG procedure (eg. significant sarcopenia)
研究组 & 干预措施
Surgical Intervention
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)
干预措施: Sleeve gastrectomy (Procedure)
No Surgical Intervention
Liver transplantation will proceed as per routine practice
结局指标
主要结局
morbid obesity
时间窗: 12 months post-liver transplant
rate of morbid obesity defined as BMI greater than or equal to 35
次要结局
- mortality(3 months post-transplant)
- surgical morbidity(3 months post-transplant)
- change in weight(12 months)
- surgical complications(12 months)
- sleep apnea(12 months post-transplantation)
- hypertension(12 months post-transplantation)
- diabetes(12 months post-transplantation)
- hyperlipidemia(12 months post-transplantation)
- mortality(12 months post-transplant)
- surgical morbidity(12 months post-transplant)