Information for Study Participants – By-Band-Sleeve Study

What is the purpose of this study?

The By-Band-Sleeve study aims to find out the best type of operation to treat obesity. There are three operations routinely offered to patients in the UK: gastric Band surgery, gastric Bypass surgery and Sleeve gastrectomy surgery. There are advantages and disadvantages with each operation.

Who is organising and funding the study?

The study is coordinated by the Bristol Trials Centre at the University of Bristol and is funded by the National Institute for Health and Care Research Technology Assessment Programme (ref: 09/127/53).

Which hospitals are taking part in the study?

The By-Band-Sleeve Study was running at twelve hospitals: Royal Bournemouth and Christchurch Hospitals, St James University Hospital, Leeds, University Hospital Southampton, Sunderland Royal Hospital, Musgrove Park Hospital, Somerset NHS Foundation Trust, Taunton, Royal Cornwall Hospital, Truro, Heartlands Hospital, Birmingham, Queen Alexandra Hospital, Portsmouth, Royal Derby Hospital, Derby, Homerton Hospital, London, St Mary’s Hospital Imperial College, London and Southmead Hospital, Bristol.

Summary of treatments being studied

It is difficult to be precise about some of the risks and benefits of the following treatments because not much research has been done. That is why we are carrying out the By-Band-Sleeve study – to ensure that we have this information for the future. We have made ‘best-guess’ estimates based on world-wide research. The below table summarises the possible advantages and disadvantages of each treatment.

Treatment	What it entails	Possible advantages
Band surgery Laparoscopic adjustable gastric band	Surgical operation taking less than 1 hour in which a band is inserted around the top of the stomach to reduce its size. An overnight stay in hospital is usually required. Follow up schedule of clinic visits for band adjustments are required. There may be up to 10 visits in the first two years. Patients are required to take long term vitamin and mineral tablets.	Requires significant dietary modification by the patient. Weight loss is gradual over a long period (2-3 years). If significant weight loss is achieved, health problems such as diabetes may resolve.
Bypass surgery Laparoscopic gastric Bypass	Surgical operation taking 1 to 2 hours in which a small pouch is made in the top of the stomach and a loop of bowel connected to this pouch to bypass the rest of the stomach. A 1 to 3 day hospital stay is required. Follow up schedule of clinic visits at 4 weeks, 3, 6 and 12 months after surgery and annually thereafter. Patients are required to take long term vitamin and mineral tablets and also require regular 3 monthly vitamin B12 injections.	Requires significant dietary modification by the patient. Rapid weight loss in first 6 months which slows then stabilises at 18 months. At this stage weight may be regained and can be significant in about 1 in 5 patients. If significant weight loss is achieved, health problems such as diabetes may resolve.
Sleeve surgery Laparoscopic Sleeve gastrectomy	The operation reduces the size of the stomach by about 75%, creating a narrow tube. It is done by stapling down the stomach and removing the remainder of the stomach. The new small stomach still works in the same way but will feel full quicker. Follow up schedule of clinic visits at 4 weeks, 3, 6 and 12 months after surgery and annually thereafter. Patients are required to take long term vitamin and mineral tablets and also require regular 3 monthly vitamin B12 injections.	Requires significant dietary modification by the patient. Patients experience weight loss over the first 12 months, which tends to plateau thereafter. If significant weight loss is achieved, health problems such as diabetes may resolve.

Treatment

What it entails

Possible advantages

Band surgery

Laparoscopic adjustable gastric band

Surgical operation taking less than 1 hour in which a band is inserted around the top of the stomach to reduce its size. An overnight stay in hospital is usually required.

Follow up schedule of clinic visits for band adjustments are required. There may be up to 10 visits in the first two years. Patients are required to take long term vitamin and mineral tablets.

Requires significant dietary modification by the patient.

Weight loss is gradual over a long period (2-3 years).

If significant weight loss is achieved, health problems such as diabetes may resolve.

Bypass surgery

Laparoscopic gastric Bypass

Surgical operation taking 1 to 2 hours in which a small pouch is made in the top of the stomach and a loop of bowel connected to this pouch to bypass the rest of the stomach. A 1 to 3 day hospital stay is required.

Follow up schedule of clinic visits at 4 weeks, 3, 6 and 12 months after surgery and annually thereafter. Patients are required to take long term vitamin and mineral tablets and also require regular 3 monthly vitamin B12 injections.

Requires significant dietary modification by the patient.

Rapid weight loss in first 6 months which slows then stabilises at 18 months. At this stage weight may be regained and can be significant in about 1 in 5 patients.

If significant weight loss is achieved, health problems such as diabetes may resolve.

Sleeve surgery

Laparoscopic Sleeve gastrectomy

The operation reduces the size of the stomach by about 75%, creating a narrow tube. It is done by stapling down the stomach and removing the remainder of the stomach. The new small stomach still works in the same way but will feel full quicker.

Requires significant dietary modification by the patient.

Patients experience weight loss over the first 12 months, which tends to plateau thereafter.

If significant weight loss is achieved, health problems such as diabetes may resolve.

Treatment	Possible short term disadvantages	Possible longer term disadvantages
Band surgery Laparoscopic adjustable gastric band	Risks related to any operation: e.g. blood loss/clots, infection, death – very rare: less than 1 in 1000. There is a 1 in 100 chance that further surgery is required shortly after first operation surgery because of problems swallowing.	Problems with the band that may require further surgery occur in about 1 in 15 patients. These are generally straight forward to fix.
Bypass surgery Laparoscopic gastric Bypass	Risks related to any operation: e.g. blood loss/clots, infection, death – rare: less than 3 in 1000. There is a 3 in 100 chance that further surgery is required shortly after the first operation because of problems specific to gastric Bypass e.g. leakage or bleeding from joins in the bowel.	Problems with the bypass that may require further surgery can occur in about 1 in 25 patients. These problems whilst less common than after a gastric band can be more serious. Patients are required to take long term vitamin and mineral tablets.
Sleeve surgery Laparoscopic sleeve gastrectomy	Risks related to any operation: e.g. blood loss/clots, infection, death – rare: less than 3 in 1000. There is a 2 in 100 chance that significant problems specific to Sleeve gastrectomy are experienced e.g. leakage or bleeding along the line of staples. This may require a second operation or a prolonged stay in hospital.	Problems with the sleeve that may require further surgery can occur in about 1 in 25 patients. These problems whilst less common than after a gastric band can be more serious.

Treatment

Possible short term disadvantages

Possible longer term disadvantages

Band surgery

Laparoscopic adjustable gastric band

Risks related to any operation: e.g. blood loss/clots, infection, death – very rare: less than 1 in 1000.

There is a 1 in 100 chance that further surgery is required shortly after first operation surgery because of problems swallowing.

Problems with the band that may require further surgery occur in about 1 in 15 patients. These are generally straight forward to fix.

Bypass surgery

Laparoscopic gastric Bypass

Risks related to any operation: e.g. blood loss/clots, infection, death – rare: less than 3 in 1000.

There is a 3 in 100 chance that further surgery is required shortly after the first operation because of problems specific to gastric Bypass e.g. leakage or bleeding from joins in the bowel.

Problems with the bypass that may require further surgery can occur in about 1 in 25 patients. These problems whilst less common than after a gastric band can be more serious.

Patients are required to take long term vitamin and mineral tablets.

Sleeve surgery

Laparoscopic sleeve gastrectomy

Risks related to any operation: e.g. blood loss/clots, infection, death – rare: less than 3 in 1000.

There is a 2 in 100 chance that significant problems specific to Sleeve gastrectomy are experienced e.g. leakage or bleeding along the line of staples. This may require a second operation or a prolonged stay in hospital.

Problems with the sleeve that may require further surgery can occur in about 1 in 25 patients. These problems whilst less common than after a gastric band can be more serious.

Will my taking part in the study be kept confidential?

All information which is collected about you during the course of the research will be kept strictly confidential. This will include details such as your name, address and NHS number, to allow us to keep in touch with you during your participation in the research. We will record information about your health which is essential to allow us to compare the three operations. All the information collected will be stored in a secure database held at the coordinating centre, and will only be accessed by authorised members of staff involved in the research. This includes the hospital research team and staff at the coordinating centre who are managing the research and will be responsible for aspects of your follow-up such as sending you questionnaires. Information about your health and participation in the research is linked to your personal data using a unique study number. The personal data is stored separately in the database and in locked filing cabinets.
Your medical notes will be seen by authorised members of the hospital research team so they can collect information about your health needed for this research study. With your consent, your GP will also be informed that you are taking part in the research study. Your GP may be asked to provide information from your records which is required for the research. Occasionally, other members of NHS staff or research staff may need to check your medical records. This will be done by NHS staff or by researchers who are bound by the same rules of confidentiality as all NHS staff. The confidentiality of your medical records will be respected at all times. Under no circumstances will you be identified in any way in any report arising from the study.

With your consent, after you leave the study we would still like to know how you are progressing using information collected routinely in the NHS and information held routinely by the NHS Information Centre. Information will be obtained from the NHS Information Centre’s ‘Medical Research Information Service’. Any information received in this way remains confidential and will only be used for the purpose of this research.

What if I do not want to carry on with the study?

If you decide not to carry on with the study, you can withdraw at any time and without giving a reason. A decision to withdraw at any time or a decision not to take part will not affect the standard of care you receive. Exactly what happens depends on when you withdraw;

If you withdraw before the operation, you will be offered the usual treatment at your hospital. However we would like to continue to follow your progress using information collected routinely in the NHS as this will be invaluable to our research.

If, after the operation, you do not want to take any further part, your care will continue in the usual way. Information and blood samples collected up to the point at which you decide to withdraw is still valuable for the study. If you decide to withdraw we will ask you whether we can continue to follow your progress using standard NHS records, we will contact you three years after you joined the study if that is ok with you.

What happens after the study finishes?

Samples: Blood samples taken for research will be stored until analysed. With your permission, your samples will be stored anonymously, potentially for many years. They will be used for this study and future approved studies into the benefits of weight-loss surgery.

Results: The first results of this study should become available at the end of the study in 2023. We will publish relevant results in scientific journals, as well as presenting regular reports at various local, national and international level scientific meetings. You will not be identified in any report/publication. We will also present the results to the local patient support group and circulate a newsletter with the main findings of the study to all who participated. In 2023 a report for the NHS will be written and the results will be used to influence future provision of surgery for obesity in the UK.

Who is monitoring the study?

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your safety, rights, wellbeing and dignity. This study has been reviewed and given a favourable opinion by South West – Frenchay Research Ethics Committee.

Need more information?

You can obtain general information on clinical research from the UK Clinical Research Collaboration (UKCRC) who produce a booklet called “Understanding Clinical Trials”. This provides in-depth information on the design and conduct of clinical trials and aims to answer the questions of those considering taking part.

Electronic copies can be downloaded from the UKCRC website here