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Landmark research recommends gastric bypass for people with severe obesity undergoing surgery

News — Gastric bypass is the most clinically and cost effective form of interventional surgery for people living with severe obesity, reveals landmark research funded and supported by the National Institute for Health and Care Research (NIHR). Today (31 March, 11.30 pm UK time), results of the By-Band-Sleeve trial are published in the Lancet Diabetes & Endocrinology. The trial was led by the University of Bristol (UK).

The largest completed trial of its kind, involving 1,346 patients, the By-Band-Sleeve trial compared Roux-en-Y gastric bypass (‘Bypass’) with two other types of metabolic and bariatric surgery - adjustable gastric banding (‘Band’) and sleeve gastrectomy (‘Sleeve’).Current national guidelines recommend surgery is considered for people living with severe obesity.

In the UK and worldwide, Bypass and Band were very commonly performed when the trial started. A third operation, Sleeve started to be performed more often during the first two years of the trial and was then included. Researchers found Bypass to be most clinically effective for patients and to provide the best value for money for the NHS three years after surgery.

Patients were recruited from 12 UK hospitals between 2013 and 2019.

Jane Blazeby, Professor of Surgery at the University of Bristol, who led the trial, said: “Based on the trial findings, we recommend patients electing to have bariatric and metabolic surgery are advised to have Bypass. Sleeve should be a secondary option when Bypass is not possible. Our evidence does not support Band as standard treatment for people living with severe obesity.“The hard work undertaken by all the study participants, surgeons, nurses and dieticians means we now have reliable information to inform NHS practice. The next challenge is for surgical teams to work with researchers and physicians to conduct a new study that compares surgery to weight loss drugs to create evidence to understand how they compare surgery in terms of weight loss, quality of life and costs.”

Professor Danny McAuley, Scientific Director for NIHR Programmes, said: "Obesity is one of the biggest challenges facing us globally and in the UK. This treatment will help save lives and improve the quality of life for patients, while providing better value for money for the NHS. “NIHR funded trial results provide vital evidence that gastric bypass improves the quality of life for UK patients and help clinicians and those providing NHS and care services choose the best treatments.“

The findings demonstrate how our life changing NIHR research, funded by the public, has impact to support the health and care sector to achieve more effective and efficient use of resources.”Compelling evidenceThe study found that 68% (276) participants randomised to Bypass achieved at least 50% excess weight loss after three years, compared to 25% (97) for Band and 41% (141) for Sleeve. On average trial participants lost 26.5kg (just over 4 stone). Some people lost as much as 98 kg (over 15 stone). There were a few that gained weight (<10%).Bypass led to a greater reduction in comorbidities, such as high blood pressure and diabetes.

Bypass was found to be the most cost effective option when taking into account patients’ quality of life using a standard UK cost threshold applied by NICE. So, although Bypass was a more costly operation initially, it led to better quality of life and lower healthcare costs after three years compared to the other two surgeries.

Based on this evidence, it is recommended that patients electing to have metabolic and bariatric surgery are advised to have a Bypass, researchers say. Where contraindicated or unfeasible, Sleeve should be offered. This evidence does not support Band surgery as standard treatment for severe obesity, they add.

Researchers also say it is now important to compare surgery with obesity management medications (OMMs) to provide evidence to optimally inform patients, surgeons and the NHS.The By-Band-Sleeve trial was funded by the NIHR’s Health Technology Assessment Programme.

Paper

'Roux-en-Y gastric bypass, adjustable gastric banding, or sleeve gastrectomy for severe obesity (By-Band-Sleeve): a multicentre, open label, three-group, randomised
controlled trial' by The By-Band-Sleeve Collaborative Group in The Lancet Diabetes & Endocrinology

Notes to editors:

Patient case study: Elaine’s story and photo's available on request.

Facts and figures

Obesity is an increasing health problem globally, with over 25% of the world’s population predicted to be affected by 2035.

Obesity is estimated to cost the UK at least £11.8bn for NHS and social care combined, for both treatment and support. Estimates for loss of productivity range from £1.7bn to £15bn.

Around 5,000 bariatric surgery operations take place annually in the UK with 55% patients undergoing Sleeve, 45% Bypass and very few now undergoing Band.

Q&A

How does gastric surgery work?

Bariatric and metabolic surgeries are reserved for the people living with severe obesity and those who also have other health problems such as high blood pressure and diabetes.

Gastric Bypass: Surgical staples used to create a small pouch at the top of the stomach. The pouch bypasses the stomach and less food will fill you up.

Gastric Band:  A band is placed around the stomach creating a small pouch towards the top. Less food is needed to fill the pouch. The band can be tightened.

Sleeve gastrectomy: Large part of stomach removed so less food is needed to make you full

All three 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.

In recent years, weight loss medications have become available. However, there are concerns about access to these drugs, the number of people who cannot tolerate them and whether people regain weight when they are stopped. So, the costs of potentially lifelong treatment need to be considered.

All patients need to have a low calorie diet for 2-4 weeks before the operation.

As part of the recovery patients start eating a liquid diet, building up to solid food later.

They also need medication including a vitamin B12 injection every 3 months to prevent deficiency due to reduced absorption.

In some cases the eventual smaller stomach size means patients may have trouble digesting food and be unable to eat some of the foods they used to eat. This limitation can include foods such as red meat. In some cases people may not have enough space in their stomach to both eat and drink during the same meal.

How does this compare to weight loss drugs?

Drugs are alternatives to weight loss surgery. However not all patients are eligible for them and some cannot tolerate them due to side effects.

Around 20% of individuals on these medications do not achieve any significant weight loss.

About one-third of patients attending weight-management clinics are medically ineligible for weight loss drug therapies.

In some cases, weight loss achieved through medication may be insufficient to improve certain medical conditions or to qualify for further treatments or procedures.

Also, weight is regained when the medications are stopped so they need to be taken for life in order to maintain weight loss.

Cost savings to NHS and social care?

• Healthcare (NHS): Approximately £6–6.5 billion annually on obesity-related treatment (source: )
• Social Care: Around £5.8 billion annually for obesity-linked support and services (source: )
• Productivity Loss: Estimates range from £1.7 billion (source: ) to over £15 billion (source: ) per year, depending on the scope of the analysis.