Gastric Bypass, Adjustable Gastric Banding or Sleeve Gastrectomy Surgery to Treat Severe and Complex Obesity: a Multi-centre Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,351
- 试验地点
- 12
- 主要终点
- The proportion achieving loss of greater than 50% of excess weight at three years.
研究概览
简要总结
Obesity is an increasing health problem in the United Kingdom (UK) and is predicted to worsen.
In the UK and worldwide the three most commonly performed operations are laparoscopic adjustable gastric banding ('BAND surgery'), laparoscopic gastric bypass ('BYPASS') and laparoscopic sleeve gastrectomy ('SLEEVE'). All lead to weight loss, but they are associated with different problems. This study (BYBANDSLEEVE) is a randomised trial with a target recruitment of 1341 patients in twelve hospitals and its aim is to compare the effectiveness, cost effectiveness and acceptability of BAND, BYPASS and SLEEVE surgery.
详细描述
Obesity is an increasing health problem in the UK and one which is predicted to worsen. It is associated with many health problems that can shorten a person's life span and impair quality of life. Current national guidelines recommend that surgery is considered for the very overweight (morbidly obese) or for those remaining obese after trying other options.
In the UK and worldwide the three most commonly performed operations are laparoscopic adjustable gastric banding ('BAND surgery'), laparoscopic gastric bypass ('BYPASS') and laparoscopic sleeve gastrectomy ('SLEEVE'). All lead to weight loss, but they are associated with different problems. In the short term there are varying complications and inconvenience relating to the operation. In the longer term there are different outcomes relating to weight regain, symptoms and side effects of surgery. This study (BYBANDSLEEVE) is a randomised trial with a recruitment target of 1341 patients in twelve hospitals and its aim is to compare the effectiveness, cost effectiveness and acceptability of BAND, BYPASS and SLEEVE surgery. The process of randomisation will mean that participants have a chance of receiving one of the three procedures, so a fair comparison between them can be made.
The first phase (in two hospitals) will test the feasibility of recruitment and optimise information for patients to maximise trial recruitment. It will establish a core set of clinical outcomes to use to evaluate the surgery for morbid obesity. The second stage (in 12 hospitals) will recruit the full sample and follow up all participants for at least three years. The investigators will compare the effects of BAND, BYPASS AND SLEEVE surgery three years after randomisation on weight loss, a wide range of symptoms and aspects of quality of life. The investigators will also examine patients' detailed experiences during follow up, nutritional outcomes, short and long term surgical complications and National Health Service (NHS) value for money.
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
- •Male or female patients
- •Over 18 years of age
- •Referred for bariatric surgery according to the National Institute for Health and Care Excellence (NICE) guidelines - BMI of 40kg/m2 or more, OR BMI of 35 kg/m2 to 40 kg/m2 and other significant disease (e.g. type 2 diabetes or high blood pressure) OR BMI of 30 kg/m2 or more and recent onset diabetes OR Asian family origin with lower BMI and recent onset diabetes, that could improve with weight loss
- •Has been or is willing to receive intensive management in a specialist tier 3 obesity service
- •Fit for anaesthesia and surgery
- •Committed to follow-up and able to complete quality of life questionnaires
- •Able to provide written informed consent.
排除标准
- •Previous gastric surgery or surgery for severe and complex obesity
- •Previous abdominal surgery or gastro-intestinal (GI) condition that precludes one or more of Band, Bypass or Sleeve
- •Large abdominal ventral hernia
- •Pregnancy (women who have given birth and women planning pregnancy will NOT be excluded)
- •Crohn's disease
- •Liver cirrhosis and portal hypertension
- •Systemic lupus erythematosis
- •Known silicone allergy
- •Hiatus hernia >5cm
- •Other clinical/psychological reason, to be specified
- •Active participation in another interventional research study which might interfere with By-Band-Sleeve
结局指标
主要结局
The proportion achieving loss of greater than 50% of excess weight at three years.
时间窗: Three years
The proportion achieving loss of greater than 50% of excess weight at three years (calculated as 100×\[BMI at 3 years - BMI at randomisation1\] / \[BMI at randomisation - 25\])
Health-related Quality of Life (HRQoL)
时间窗: Three years
HRQoL at three 3 years, will be assessed using the EQ-5D-5L
次要结局
- Waist circumference at 3 years(Three years)
- Resource use to three years(Three years)
- Dietary recall(Three years)
- Adverse health events(Three years)
- Time taken from first losing 50% excess BMI to first relapse(Three years)
- Time to resolution of co-morbidities(Three years)
- Standard healthcare blood tests(Three years)
- Change in BMI over time adjusted for BMI at randomisation(Three years)
- Percentage weight loss at 3 years(Three years)
- Time taken from randomisation to reach first loss of at least 50% of excess BMI(Three years)
- Binge eating behaviour(Three years)
- Resolution of co-morbidities(Three years)
- Generic and symptom specific Health-related Quality of Life (HRQOL)(Three years)
研究者
Jane Blazeby
Chief Investigator
University of Bristol