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
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,351
研究概览
简要总结
2014 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/24393291 recruiter perspectives 2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/24517309 protocol 2014 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/24633209 most effective operation for adults with severe and complex obesity: 2015 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/25442513 development of a core outcome set 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26710760 qualitative case study results from By-Band 2016 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/27169605 NHS access to bariatric surgery 2016 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/27034443 use of adjustable gastric bands for management of severe and complex obesity: 2016 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/27755555 conveying equipoise during recruitment: 2016 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/27138600 health professionals' and patients' views of the importance of outcomes 2016 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/27898680 core outcome set 2017 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/28703939 adaptation of By-Band randomized clinical trial 2017 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/28550438 costs of bariatric surgery 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28703939 By-Band pilot study results and explanation of By-Band-Sleeve design 2017 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/28669987 enabling recruitment success 2017 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/29252996 EQ-5D-5L to measure health-related quality of life: 2019 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/30339938 QuinteT Recruitment Intervention 2019 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/30368646 micro-costing of procedures 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38171620/ prevalence, and severity, of anxiety and depressive symptoms (added 08/01/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 23/09/2015:
- •Participants may enter study if ALL of the following apply:
- •1. Male or female patients
- •2. Over 18 years of age
- •3. Referred for bariatric surgery according to 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
- •4. Has been or is willing to receive intensive management in a specialist tier 3 obesity service
- •5. Fit for anaesthesia and surgery
- •6. Committed to follow-up and able to complete quality of life questionnaires
- •7. Able to provide written informed consent
- •Previous inclusion criteria:
- •The participant may enter study if ALL of the following apply:
- •1. Male or female patients
- •2. Over 18 years of age
- •3. Referred for bariatric surgery according to NICE guidelines - BMI of 40kg/m2 or more, OR BMI of 35 kg/m2 to 40 kg/m2 and other co-morbidities (e.g. type 2 diabetes), that could improve with weight loss
- •4. Willing to receive intensive management in a specialist obesity service
- •5. Fit for anaesthesia and surgery
- •6. Committed to follow-up and able to complete quality of life questionnaires
- •7. Able to provide written informed consent
排除标准
- •Current exclusion criteria as of 23/09/2015:
- •Participants may not enter study if ANY of the following apply (assessed by patient history and clinical examination)
- •1. Previous gastric surgery or surgery for severe and complex obesity
- •2. Previous abdominal surgery or gastro-intestinal (GI) condition that precludes one or more of Band, Bypass or Sleeve
- •3. Large abdominal ventral hernia
- •4. Pregnancy (women who have given birth and women planning pregnancy will NOT be excluded)
- •5. Crohn’s disease
- •6. Liver cirrhosis and portal hypertension
- •7. Systemic lupus erythematosis
- •8. Known silicone allergy
- •9. Hiatus hernia >5cm
- •10. Other clinical/psychological reason, to be specified
- •11. Active participation in another interventional research study which might interfere with By-Band-Sleeve
- •Previous exclusion criteria:
- •The participant may not enter study if ANY of the following apply:
- •1. A history of previous gastric surgery or surgery for morbid obesity
- •2. Large abdominal ventral hernia
- •3. Hiatus hernia more than 5 cm
- •4. Pregnancy (women who have given birth and women planning pregnancy will NOT be excluded)
- •5. Crohn's disease
- •6. Liver cirrhosis and portal hypertension
- •7. Systemic lupus erythematosis
- •8. Known silicone allergy
- •9. Surgeon unwilling to for patient to be randomised (reason to be specified)