The Bluebelle study: a feasibility study of three wound dressing strategies in elective and unplanned surgery

Funder: NIHR/HTA

Sponsor: University Hospitals Bristol 

Status: Published

Wound infections occur commonly after surgery, leading to pain, discomfort and inconvenience for patients and increased healthcare costs for the NHS.  There is controversy about the role of wound dressings in preventing infection.  Although frequently used in adults after surgery, it is rare to apply dressings to wounds after surgery in children.  A recent scientific review found no evidence to suggest that covering surgical wounds with dressings in adults and children reduces the risk of wound infection, or that any particular wound dressing is more effective than another.  However, most of the studies identified for this review were small and had design faults.  The studies also used different methods to define and measure wound infections. 

Bluebelle is a feasibility study consisting of two phases.  Phase A included interviews with health professionals and patients to explore views and acceptability about types of dressings and/or not using a dressing, with the aim to understand current practice in relation to dressings for particular procedures. We also wanted to develop a valid method for assessing wound infection, as the current methods vary and lack good agreement.

In phase B we conducted a pilot randomised controlled trial (RCT) to determine how easy it is to recruit participants into this type of study, whether expected recruitment rates can be met and whether the method for assessing wound infection developed in Phase A is valid.  A total of 394 participants were randomised into the pilot RCT. The results of the study are currently being written up for publication, and information from the study will be used to decide if a large trial comparing wound dressings with no dressings is possible. The results will be published in 2019. If feasible the main trial is likely to include over 1,000 participants and will compare the effectiveness of different types of wound dressing in general and obstetric surgery.

Further information can be found here: http://www.bristol.ac.uk/social-community-medicine/centres/surgical-research/research/pilot/bluebelle/ 

Publications

Phase A results paper http://bmjopen.bmj.com/content/6/9/e012635 

Phase B protocol paper https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2102-5%20#trialsjournal 

Final results paper https://www.journalslibrary.nihr.ac.uk/hta/hta23390#/abstract 

Phase B Results paper https://www.ncbi.nlm.nih.gov/pubmed/31932387 

Contact Information

Chief Investigator: Prof. Jane Blazeby

Study coordinator: Kate Ashton

E-mailbluebelle-study@bristol.ac.uk

 

Gastric Bypass, adjustable gastric Banding or Sleeve gastrectomy surgery to treat severe and complex obesity: a multi-centre randomised controlled trial

Funder: NIHR/HTA 

Sponsor: University of Bristol 

REC number: 11/SW/0248

Status: In Follow Up

Obesity is an increasing health problem in the UK. Current national guidelines recommend that surgery is considered for people with severe and complex obesity. This surgery is known as bariatric surgery. Three of the most common types of bariatric surgery operations are: the adjustable gastric band (‘Band’), the Roux-en-Y gastric bypass (‘Bypass’), and the gastric sleeve (‘Sleeve’). At the moment, health professionals do not know which of these three operations is the most effective for long-term weight loss and improvement of health problems and quality of life.

 The By-Band-Sleeve study is aiming to compare the three different types of operations to find out which is most effective. The results of this study will be used to improve the information available to people considering bariatric surgery in the future, which will help with decision-making between health professionals and patients. The results will also be used to inform NHS commissioners about the most effective and cost-effective operation.

The By-Band-Sleeve Study is currently running at twelve hospitals: Royal Bournemouth and Christchurch Hospitals, St James University Hospital (Leeds), University Hospital Southampton, Sunderland Royal Hospital, Musgrove Park Hospital (Taunton), Royal Cornwall Hospital (Truro), Heartlands Hospital (Birmingham), Queen Alexandra Hospital (Portsmouth), Royal Derby Hospital, North Bristol, Homerton Hospital (London) and St Mary's Hospital Imperial College (London).

Adults who are referred for bariatric surgery at any of these hospitals can take part in the study. Patients are given some information to read about the study and the chance to discuss it with the health professionals on the team. Those who agree to take part will have an equal chance of being assigned a gastric band, a gastric bypass, or a gastric sleeve. This allows the three types of operations to be compared in a balanced way. Participants will be told which operation they have been assigned to several weeks before their actual operation date. It is planned that 1341 patients will take part in the study in total.

After surgery, participants will be followed up carefully, including regular weight checks. They will be asked to complete questionnaires about their quality of life and use of healthcare. Some participants will also be interviewed about their experience. Researchers will also ask participants to provide two blood samples for future research into obesity, in addition to the samples people would give as part of their normal care. All participants will be followed up by the study team for three years.

The study is coordinated from the Clinical Trials and Evaluation Unit at the University of Bristol and involves a team of experts, including researchers from the Universities of Bristol, Birmingham, Oxford, and Southampton, and health professionals from each of the study hospitals. The started in 2012, active recruitment will take place until September 2019, and the study will end when the final patient as completed follow up. The study is funded by the National Institute for Health Research Health Technology Assessment Programme (ref: 09/127/53).

As of September 2019, recruitment to By-Band-Sleeve reached its target of 1341 randomised patients and is therefore in the follow up phase.  With recruitment completed there is now the opportunity for patients to take part in a By-Band-Sleeve sub-study – the Metabolomics Study. The aim of this study is to find out how the body responds to weight loss following bariatric surgery. The study involves donating a small sample of blood before surgery and again one year later. These samples will be used to look for small molecules whose levels change with weight loss.

We anticipate the By-Band-Sleeve/Metabolomics study will be recruiting at these hospitals: University Hospital Southampton; Musgrove Park Hospital, Taunton; Royal Cornwall Hospital, Truro; Heartlands Hospital, Birmingham; Queen Alexandra Hospital, Portsmouth; Homerton Hospital, London; St Mary's Hospital Imperial College, London;  Southmead Hospital, North Bristol Trust.

Adults who are referred for bariatric surgery (gastric band surgery, gastric bypass surgery or sleeve gastrectomy surgery) at any of these hospitals and meet the eligibility criteria for the study can take part. Patients will be eligible regardless of the type of surgery they are planning to have. Patients are given some information to read about the study and the chance to discuss it with the health professionals on the team. If patients decide to take part in the study, their operation will take place in the same way that it would normally. All participants will be followed up by the study team one year after their surgery.

The study is led by Professor Nic Timpson and coordinated by Dr Laura Corbin both of whom are based in the Bristol Medical School, University of Bristol. They are supported by the main By-Band-Sleeve study team from the Clinical Trials and Evaluation Unit at the University of Bristol. The Metabolomics Study started in September 2019 and will end when the final patient has completed follow up and all data has been analysed. The study is funded by the Wellcome Trust (ref: 202802/Z/16/Z).

Contact Information

Chief Investigator: Professor Jane Blazeby

Study coordinator: Dr Graziella Mazza

E-mailby-band-sleeve@bristol.ac.uk

Websitewww.by-band-sleeve.bristol.ac.uk

Some descriptionBy-Band-Sleeve twitter

 

The CIPHER Study (Phase B)

Funder: NIHR/HTA 

Status: Recruiting

During abdominal surgery it is sometimes necessary to create a stoma to divert faeces or urine from the intestinal or urinary tract into an external pouch or bag. Unfortunately, the formation of the stoma can be associated with future complications, including the risk of developing a parastomal hernia (PSH). A PSH is a hernia immediately adjacent and related to the stoma that occurs when the muscle in the body wall splits; contents of the abdomen, e.g. fatty tissue or intestine, can be forced through the split in the muscle causing a bulging of the skin. PSH are relatively common and affect approximately 40% of patients within 2 years of their bowel surgery.

Complications of PSH can be severe and are known to negatively influence patient quality of life. Specifically, PSH can make it difficult to attach stoma bags which can cause the bag contents to leak and smell, irritate the surrounding skin and make patients anxious and avoid social situations. PSH can also cause pain and serious problems, e.g. bowel obstruction, which need emergency treatment in hospital. PSH are difficult to manage and in most cases treatment involves specialist stoma care with expensive appliances. In some cases, a surgeon may reoperate to repair the hernia but additional surgery is itself a risk factor for recurrence of a hernia. Stopping a PSH forming in the first place is therefore very important.

Both patient and surgical factors are believed to influence the development of PSH. Of the surgical factors, the size and shape of the incision in the body wall, the use of mesh when the stoma is formed and, if mesh is used, exactly how mesh it is used, have all been described as potentially important considerations. However, the way in which surgeons create stomata is very varied and research is needed to investigate whether these factors influence the risk of developing a PSH. This is the aim of the CIPHER study.

The CIPHER study aims: (a) to establish the incidence of symptomatic and radiologically confirmed PSH during a minimum of 2 years follow up; and (b) to evaluate the effects of key technical surgical steps when a stoma created on the risk of developing a PSH. To achieve these aims, some preliminary research (Phase A) needs to be carried out to enable the main study (Phase B) to be designed optimally.

Objectives of Phase A are:

A1   To define key technical surgical steps when a surgeon creates a stoma and how these steps vary between surgeons.

A2   To develop a questionnaire for patients to report symptoms of PSH.

Objectives of Phase B are:

  1. To describe the incidence of PSH formation within 2 years of creation of a stoma and how the risk of PSH varies for different types of stoma.
  2. To describe the risk of PSH according to the way the surgeon creates an opening in the abdominal wall.
  3. To describe the risk of PSH according to whether a mesh is used and, if yes, the type of mesh and how it is used.
  4. If a mesh used, to describe the risk of PSH according to how it is used.

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Use of data in future research:

When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research.

Your information could be used for research in any aspect of health or care, and could be combined with information about you from other sources held by researchers, the NHS or government. Where this information could identify you, the information will be held securely with strict arrangements about who can access the information. The information will only be used for the purpose of health and care research, or to contact you about future opportunities to participate in research. It will not be used to make decisions about future services available to you, such as insurance. Where there is a risk that you can be identified your data will only be used in research that has been independently reviewed by an ethics committee.

Contact Information

Chief InvestigatorMr Neil Smart, Consultant Colorectal Surgeon, Royal Devon & Exeter NHS Foundation Trust

Study Coordinator: Hana Tabusa

E-mail: cipher-study@bristol.ac.uk

 

Evaluation of multi parametric magnetic resonance imaging for characterising lymph node status, peritoneal and liver metastasis in pancreatic cancer

Funder: David Telling Trust and UHBristol Research Capability Funding (RCF)

Sponsor: University Hospitals Bristol 

REC Number: 16/SW/0105

Status: Recruiting

Whipple’s procedure (pancreaticoduodenectomy) is the most common operation to treat pancreatic cancer.  It is a complex procedure, involving the removal of part of the pancreas and the first part of the small intestine (duodenum). The operation is only beneficial if the cancer has not spread outside the pancreas.   Doctors currently determine whether the cancer has spread by using a computed tomography (CT) scan to take pictures of the pancreas and surrounding organs. The CT scan does not pick up small tumours, so some patients have surgery unnecessarily, since their cancer spread can only be assessed visually when the abdomen is opened at surgery.  In these patients the Whipple’s procedure does not go ahead.

The EVALUATE study is looking at using another type of scan, a magnetic resonance imaging (MRI) scan, to determine if small tumours that may have spread from the pancreas can be picked up.

The study will recruit 30 patients who are referred for surgery and ask them to undergo a MRI scan before surgery at CRIC Bristol.

The MRI will be assessed after the patients have had their surgical treatment. Doctors will attempt to identify from the MRI scan whether the cancer has spread and make a decision based on the MRI if the patient should have been referred for surgery or not.

The decision to proceed with the surgery based on the MRI scan will then be compared with the same decision made by the surgeon at surgery. If the MRI is good at doing this, it will improve the decision making process and prevent unnecessary surgery in some patients who are currently referred for a Whipple’s procedure.

 

 

Contact Information

Chief Investigator: Mr Reyad Abbadi, Consultant Surgeon, Bristol Royal Infirmary

Study coordinator: Jon Evans

E-mailevaluate-study@bristol.ac.uk

 

Information on the GAP Study can be found here

Contact Information

Chief Investigator: Dr Ben Gibbison 

Lead Applicant: Professor Chris Rogers

Study coordinator: Sarah Baos

E-mailgap-study@bristol.ac.uk

 

Information on the INSPIRE study can be found here

 

Randomised Oesophagectomy: Minimally Invasive or Open

Funder: NIHR/HTA 

Sponsor: University Hospitals Bristol 

Status: In Follow Up  

Oesophageal (gullet) cancer is relatively common in the UK. If detected early, it may be cured with surgery (oesophagectomy). Different surgical approaches are routinely used to treat oesophageal (gullet) cancer – open surgery or combined open and keyhole surgery (“combined surgery”).  The approaches are very similar, both approaches aim to remove the cancer and replace the gullet with the stomach.  ‘Open surgery’ is performed by making large incisions in the abdomen and the chest.  ‘Combined surgery’ is performed by making a large incision in the chest and 4 to 8 small cuts in the tummy.  In both approaches sometimes incisions may be made to the neck.  

The operation is complex and although the benefit of surgery is survival, surgery is followed by a reduction in health quality of life.  At the moment we do not know which surgical approach is best for removing the cancer and for the patient in terms of recovery.  The ROMIO study aims to find out which is the best surgical approach to treat oesophageal cancer. 

Half of the patients who take part will be treated with “open surgery”, the other half will be treated with “combined surgery”. The results of each group will be compared to see if one surgical approach is better overall than the other.

The ROMIO trial will recruit 406 patients in total, at 8 surgical centres which will allow important differences in surgical recovery to be detected. We will also collect data, to allow a comparison of the cost-effectiveness of the two approaches to provide information relevant to policy making in the NHS.

Publications:

Comparing open and minimally invasive surgical procedures for oesophagectomy in the treatment of cancer: the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) feasibility study and pilot trial

Protocol paper https://bmjopen.bmj.com/content/9/11/e030907 

Quality Assurance Protocol paper https://bmjopen.bmj.com/content/9/3/e026209

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Contact Information

Chief Investigator: Mr Paul Barham, Consultant Upper GI Surgeon, University Hospitals Bristol NHS Foundation Trust

Study coordinator: Rachel Brierley

E-mail: romio-study@bristol.ac.uk

 

Funder: NIHR HTA

Funder reference: NIHR127850

Sponsor: University Hospitals Bristol NHS Foundation Trust

Status: In set-up

Study Summary 

Pressure ulcers mainly affect older people confined to a bed or chair, however younger or seriously ill patients with limited movement can be affected. Pressure ulcers range in severity from red skin to deep wounds through muscle to bone. They have a major impact on quality of life and are a costly problem for the NHS.

Common treatments for pressure ulcers include pressure relief and dressings. Surgery can be used to try and close deep pressure ulcers but in the UK this treatment is uncommon. It is not currently clear which patients may benefit from surgery and which of the different ways of doing the surgery seems best.

The SIPS study will involve three workstreams. The first will update literature reviews in this topic and survey healthcare professionals who manage severe pressure ulcers. The second will analyse data collected routinely in the NHS to describe the care currently provided to patients with severe pressure ulcers. The third is a consensus process among both healthcare professionals and patients to make recommendations about treatment with surgery.

 

Contact Information

E-mailsips-study@bristol.ac.uk, @SipsStudy 

 

 

Funder: NIHR HTA

Funder reference: NIHR127849

Sponsor: North Bristol NHS Foundation Trust

Status: In set-up

Study Summary

Knee injuries are common and can lead to pain and disability. Injuries to the smooth cartilage that lines the ends of the bone in joints can cause ongoing problems as the cartilage does not have a blood supply and rarely heals once injured. 10,000 people a year in the UK have a severe articular cartilage injury that warrants surgical treatment. There are two main ways in which these injuries can be treated surgically, the first is to try to address the symptoms without trying to restore the cartilage; such as cleaning (debriding) the area or replacing the damaged area with an implant. The other way is to try to repair or restore the cartilage in the damaged area. Cartilage does not grow back on its own, so an operation known as “microfracture” can be done to encourage the cartilage to grow. A surgical tool is used to make perforations in the bone in the damaged area which allows blood and bone marrow to seep out of the holes, encouraging healing. A “scaffold”, which is usually made of the same material that makes up most of the cartilage (collagen), can be added, termed Autologous Matrix-Induced Chondrogenesis (AMIC). The scaffold is secured in place and acts as a template for new cartilage to form on. It is not clear if using a scaffold improves the outcome for patients. Using scaffold makes the operation more complex (approximately 20 minutes longer) and the cost of the scaffold adds approximately £900, so it is important to establish if adding a scaffold results in a better outcome for patients and is cost-effective for the NHS.

The study will find out whether adding the scaffold is worthwhile or not for patients with knee articular cartilage injuries. Over 2 years we will aim to recruit 176 patients from at least 16 hospitals, who will be randomised into two equal sized groups. One group will have microfracture alone and the other will have microfracture plus scaffold (AMIC). Everything else will be the same for all patients. Both groups will be followed for 2 years by clinical review and questionnaire and information about quality of life, the symptoms and pain in the knee, complications of surgery, need for further surgery and costs to the NHS and patients will be collected.

Funder acknowledgement: This study is funded by the National Institute for Health Research-Health Technology Assessment Programme (NIHR127849). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

 

Contact Information

Chief Investigator: Michael Whitehouse

Trial Co-Ordinator: Holly Mckeon

E-mail:  sismic-study@bristol.ac.uk

 

Funder: NIHR HTA, Ref 16/142/04

REC Number: 18/YH/0358

Status: Recruiting 

Sponsor: Leeds Teaching Hospitals NHS Trust

A randomised controlled trial to establish the clinical and cost effectiveness of expectant management versus pre-operative imaging with magnetic resonance cholangiopancreatography (MRCP) in patients with symptomatic gallstones undergoing laparoscopic cholecystectomy at low or moderate risk of common bile duct stones: The Sunflower Study

Surgery to remove the gallbladder is required if it contains gallstones that cause problems. About 70,000 operations are performed annually in England. Sometimes, gallstones cause other problems if they pass from the gallbladder into the nearby bile duct. Then it is necessary to remove the bile duct stones before or during the gallbladder operation. Because of this, patients requiring gallbladder surgery are assessed for risk of bile duct stones. If the risk is high, further tests are done to identify if bile duct stones are present. If the risk is moderate or low, then it is uncertain whether further tests to look for bile duct stones are necessary. As a result, some surgeons choose to perform tests and others don’t.

The Sunflower Study will find out whether testing for bile duct stones before gallbladder surgery is worthwhile or not in patients with a low or moderate risk of having stones. Patients who consent to participate will be divided into two groups. One group will go straight to surgery (i.e. no additional test) and the other will be tested before surgery. The ‘straight to surgery’ group will have twice as many people in as the ‘tested’ group to reduce the number of extra tests performed. Both groups will be followed up for 18 months and information about the need for treatment of bile duct stones, complications of surgery and costs collected.

You can follow all the latest study news and updates on Twitter: @SunflowerStudy 

Summer 2019 Newsletter

Contact Information

Chief Investigator: Professor Giles Toogood

Trial Co-Ordinator: Maddie Clout

E-mail: sunflower-study@bristol.ac.uk

Website: http://cteu.bris.ac.uk/sunflower