In the UK alone, obesity is a major health problem with more than one quarter of adults estimated to be obese. Obesity promotes the development of many serious diseases including diabetes, heart disease, kidney disease, and increased risk of some cancers. Patients living with obesity also suffer from significant symptoms that impact their life including shortness of breath, back pain, poor mobility, and poor mental health. Traditional methods to help lose weight include low calorie diets and increased exercise. These may be effective in the short-term, but due to powerful biological mechanisms they are hard to maintain over the long-term and most individuals are unable to achieve normal weight. This means many people may need bariatric surgery that is highly effective at lowering body weight, but it is associated with complications and not all patients will want or be able to undergo surgery. This has led to the development of many new obesity treatments that are completed with an endoscope. An endoscope is a thin flexible tube that has a camera at the end. It is inserted through the mouth and into the stomach and small bowel. There are various procedures that can be done at the time of endoscopy that have been shown to be effective with a low number of side-effects. These are still relatively new compared to more traditional treatments and only a small number of doctors can perform them within the UK. Due to these limitations, the aim of this registry is to obtain real-world information on the safety and effectiveness of these procedures across the UK. The investigators hope over time this will improve the knowledge of clinicians about treating obesity with endoscopy and support future access and funding to these treatments.
This is a national, multi-centre, prospective, UK registry that aims to determine the safety and efficacy of metabolic and bariatric endoscopic procedures used in the treatment of obesity and related complications. The investigators will do this by determining the effect of primary bariatric procedures (gastroplasty, intragastric balloons (IGB)), revisional bariatric procedures (Transoral outlet reduction endoscopy (TORe), gastroplasty revision), and primary metabolic procedures (Duodenal Mucosal Resurfacing (DMR)), completed by endoscopists within the UK. The objective of this registry is to collect demographic, procedural and follow-up outcome data on the use of metabolic and bariatric endoscopic procedures in patients with obesity and/or obesity-related complications. This registry will provide real-life outcomes on the use of these novel endoscopic devices from multiple centres participating across the UK to provide longer-term safety and efficacy data. In addition, the registry will enable development of a UK-wide research network to support further research, innovation, and training into metabolic and bariatric endoscopy.
Study Type
OBSERVATIONAL
Enrollment
300
Endoscopic suturing of the stomach to reduce volume and promote weight loss with either the Apollo Overstitch or Overstitch Sx system.
Endoscopic plication of the stomach to reduce volume and promote weight loss with either the POSE or Endomina system.
Endoscopic suturing or plication of the stomach among patients who have previously undergone gastroplasty, sleeve gastrectomy, or Roux-en-Y gastric bypass to restrict the stomach and promote weight loss
Reduction of the size of the gastro-jejunal anastomosis among patients who have previously undergone Roux-en-Y gastric bypass to promote weight loss. A variety of techniques may be used alone or in isolation including suturing (Apollo Overstitch), plication (POSE), argon photocoagulation, and endoscopic submucosal resection/dissection.
Endoscopic ablation of the post-ampullary duodenal mucosal to enhance improvement in glycaemic control among patients with type 2 diabetes.
The insertion of an intragastric implant into the stomach, which is subsequently filled with air or water to promote weight loss. Several intragastric balloons are available including Allurion, Heliosphere, Obalon, Orbera, and Spatz.
Cleveland Clinic London
London, United Kingdom
RECRUITINGTotal body weight loss percentage (TBWL%)
For primary or revisional bariatric procedures: Percentage weight loss will be calculated using the following formula: TBWL% = \[(weight at the baseline-weight at the end of time period)/weight at baseline\] x 100
Time frame: 6-months, 1-, 2-, 3-, 5-years
Change in glycated haemoglobin (HbA1c; mmol/mol)
For primary metabolic procedures
Time frame: 6-months, 1-, 2-, 3-, 5-years
Change in the number and dose of anti-diabetic medications
For primary metabolic procedures
Time frame: 6-months, 1-, 2-, 3-, 5-years
Procedure time (mins)
Time frame: Baseline
Inpatient stay (days)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Adverse events
Time frame: 30-day, 6-months, 1-, 2-, 3-, 5-years
Change in systolic blood pressure measurements (mmHg)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Change in diastolic blood pressure measurements (mmHg)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in number and dose of anti-hypertensive medications (n)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in low-density lipoprotein cholesterol (mmol/L)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in triglycerides (mmol/L)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in high-density lipoprotein cholesterol (mmol/L)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in total cholesterol (mmol/L)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in alanine transaminase (IU/L)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in aspartate aminotransferase (IU/L)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in Fibrosis-4 Index for Liver Fibrosis
The Fibrosis-4 Index for Liver Fibrosis provides a probability score for the presence of hepatic fibrosis. It is based on age, ALT, AST, and platelet count. The range of the score is wide but there are two main cut-offs point for prediction of advanced fibrosis (\<1.3 and \>2.67). Higher scores indicate a higher likelihood of advanced fibrosis.
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in non-alcoholic fatty liver disease fibrosis score
The non-alcoholic fatty liver disease fibrosis score provides a probability score for the presence of hepatic fibrosis. It is based on age, body mass index, impaired fasting glucose, ALT, AST, albumin and platelet count. The range of the score is wide but there are two main cut-offs for prediction of advanced fibrosis (\<-1.455 and \>0.676). Higher scores indicate a higher likelihood of advanced fibrosis.
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in weight (kg)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in body mass index (kg/m2)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in glycated haemoglobin (HbA1c; mmol/mol)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in number and dose of anti-diabetic medications (n)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in number and dose of anti-obesity medications (n)
Time frame: 6-months, 1-, 2-, 3-, 5-years
Changes in health-related quality of life scores (EuroQol-5D-5L)
The EuroQol-5D-5L is a quality of life questionnaire that is composed of five questions scored 1-5 that do not have an arithmetic value and a visual analogue scale between 0-100. Participants are simply given a five digit code (e.g. 13455) and a visual analogue score (e.g. 78), which can then be interpreted through reference value sets in the corresponding country.
Time frame: 6-months, 1-, 2-, 3-, 5-years
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