Obesity Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
Current interventions as of 23/09/2015:
All three surgical procedures (Band, Bypass and Sleeve) will be carried out laparoscopically. The methods used to create a pneumoperitoneum, the placement of th
Sponsors
University of Bristol (UK)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 23/09/2015: There are two primary endpoints: 1. The proportion achieving loss of greater than 50% of excess weight at three years (calculated as 100×[BMI at 3 years – BMI at randomisation*] / [BMI at randomisation – 25]) 2. HRQOL at three years (EQ-5D-5Lhealth state score) *Calculated using the participant weight recorded at baseline, after consent and before randomisation Previous primary outcome measures: The BY-BAND trial will compare weight loss and quality of life after the laparoscopic adjustable gastric banding operation (BAND) and the laparoscopic gastric bypass operation (BYPASS) to treat morbid obesity. There are two co-primary outcomes: 1. The proportion achieving loss of greater than 50% of excess weight at three years (calculated as 100×[BMI at 3 years - BMI at randomisation] / [BMI at randomisation - 25]) 2. HRQOL at three years (EQ-5D health state score). The hypothesis that the trial is testing, that the Bypass operation is superior to the Band operation, will be supported if: 1. Bypass is not inferior with respect to weight loss at 3 year AND 2. Bypass is superior to Band with respect to health-related quality of life | — |
Secondary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 23/09/2015: To compare the cost effectiveness of the three operations, their acceptability and quality of life after surgery, nutritional outcomes, time to resolution of co-morbidities and complications. We will explore, in a sample, patients’ experiences of surgery, outcomes and lifestyle change. We will also develop a core set of outcomes to use in future trials of morbid obesity surgery. The secondary endpoints include: 1. Change in BMI over time adjusted for BMI at randomisation 2. % weight loss at 3 years 3. Waist circumference at 3 years 4. Time taken from randomisation to reach first loss of at least 50% of excess BMI 5. Time taken from first losing 50% excess BMI to first relapse (defined as weight re-gain such that the target of at least 50% of excess weight loss is no longer met) 6. Generic and symptom specific (i.e. obesity and GI specific) HRQOL: SF12, EQ5D, IWQOL-Lite, and GIQLI to three years 7. Resource use to three years 8. Standard NHS nutritional blood tests will be performed at each assessment including; full blood count, electrolytes, creatinine, glucose, HbA1c, liver function tests, iron, ferritin, vitamin B12, folate/red cell folate, lipid profile, 25-hydroxyvitamin D, calcium, parathyroid hormone 9. Measures of 24 hour recall eating using a standardised and validated interview process 10. Binge eating behaviour using a validated questionnaire 11. Adverse health events including the need for re-operation and cross over between interventions 12. Resolution of co-morbidities at 3 years, including sleep apnoea, non-alcoholic fatty liver disease, type 2 diabetes, hypertension and hyperlipidaemia 13. Time to resolution of sleep apnoea, type 2 diabetes, hypertension and hyperlipidaemia Previous primary outcome measures: To compare the cost-effectiveness of the two operations, their acceptability and quality of life after surgery, nutritional outcomes, time to resolution of co-morbidities and compl | — |
Countries
England, United Kingdom
Outcome results
None listed