Prospective Randomized Trial Comparing Endoscopic Sleeve Gastroplasty Versus Conventional Laparoscopic Sleeve Gastrectomy in Patients With Morbid Obesity: From Physical and Functional Outcomes to Changes in Hormonal Profiles
试验速览
- 阶段
- 不适用
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Percentage of excess weight loss
研究概览
简要总结
Obesity and its related metabolic disorders are increasingly a heavy health burden to many parts of the world. Weight control is a well-known important step in avoiding type 2 diabetes mellitus (T2DM). It is also an essential component for normalizing the blood glucose and preventing macrovascular and microvascular insults to patients with diagnosed T2DM. However, life-style modification, physical exercise and dietary adjustment are ineffective measures which are unlikely to confer adequate and sustainable weight loss for the truly obese. On the other hand, large scale long-term follow-up studies have confirmed the role of bariatric surgery in providing durable weight loss and remarkable improvement on medical comorbidities. Among all the bariatric operations, laparoscopic sleeve gastrectomy (LSG) is currently the most widely adopted procedure worldwide because of its simplicity and effectiveness in weight reduction. However, LSG is not without risk. Staple-line hemorrhage, leakage and stenosis are potentially life-threatening complications. LSG is also costly because of the need for expensive laparoscopic staplers.
详细描述
A new endoscopic bariatric therapy, namely endoscopic sleeve gastroplasty (ESG), has recently been proposed as a non-surgical procedure for the management of obesity with or without diabetes mellitus. Preliminary data based on single arm series or phase II studies have reported promising short and intermediate term weight control effect.
However, whether ESG is a feasible option comparable to LSG in the intermediate term remains an unanswered question. In addition, physical and functional outcomes after ESG were not well documented in most of the reported series.
Realizing there is a knowledge gap in applying ESG to patients with morbid obesity, we propose to study and compare the efficacy of weight control and functional outcomes of ESG against conventional LSG. Through this prospective randomized trial, the safety profiles, quality of life and changes in fasting and post-prandial gut hormone secretion after the two procedures will also be assessed and compared. The evidence thus generated shall lay a scientific foundation for ESG which may become an alternative choice for patients who have concerns about complication and irreversibility of most bariatric surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A BMI > 35 kg/m2
- •A BMI > 30 kg/m2 with T2DM
- •A BMI>3 30kg/m2 with 2 or more co-morbidities
排除标准
- •Significant anaesthetic risk (> ASA III)
- •History of diabetic ketoacidosis or hyperosmolar coma
- •Uncontrolled T2 DM with HbA1c > 12%
- •A BMI > 45 kg/m2
- •Malignancy diagnosed within 5 years
- •Endoscopic findings of any pre-neoplastic/neoplastic lesions, portal hypertensive gastropathy or significant varices
- •Chronic renal failure requiring dialysis
- •Previous upper abdominal surgery (including bariatric surgery) affecting gastroduodenal configuration
- •Major psychiatric illness including major depression and substance abuse
- •Pregnancy or ongoing breast-feeding
研究组 & 干预措施
Endoscopic Sleeve Gastroplasty
A series of full thickness sutures done with Overstitch in the triangular stitch pattern as mentioned by Lopez-Nava[29] will be placed according to the APC markings. The suturing is initiated from the antrum distally and moved proximally towards the gastric fundus. A total of 6 to 8 plications are placed to reduce the gastric lumen. Five sham dressings would also be applied to patient's abdominal wall during the first week to minimize the bias in pain scoring.
干预措施: Endoscopic Sleeve Gastroplasty (Procedure)
Laparoscopic Sleeve Gastrectomy
Sleeve gastrectomy is then performed using lapaorscopic linear staplers, starting from a point 5-6cm proximal to the pylorus up to the angle of His along the left side of the Mid-sleeve tube. Haemostasis of the staple line is secured by suture plication with the Mid-sleeve tube in situ to ensure no compromise of the gastric tube lumen. All the wounds are closed with staples after local anaesthetic infiltration and covered with non-transparent dressings.
干预措施: Laparoscopic Sleeve Gastrectomy (Procedure)
结局指标
主要结局
Percentage of excess weight loss
时间窗: 1 year
次要结局
- operative time(during operation)
- postoperative hospital stay(30 days)
- total blood loss intra-operation(during operation)
- early postoperative pain scores(7 days)
- perioperative complications(30 days)
- Percentages of excess weight loss(1 year)
- total weight loss(1 year)
研究者
Enders K.W. Ng
Professor
Chinese University of Hong Kong