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

Funder: NIHR/HTA

Sponsor: University Hospitals Bristol 

Status: Analysis

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 study is currently in the analysis phase and information from it will be used to decide if a large trial comparing wound dressings with no dressings is possible.  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.

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Contact Information

Chief Investigator: Prof. Jane Blazeby

Study coordinator: Kate Ashton


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: Recruiting

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 eleven 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, Derby, 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 study started in 2012 and will run for approximately eight years, until the final patient has completed follow-up. The study is funded by the National Institute for Health Research Health Technology Assessment Programme (ref: 09/127/53).


Contact Information

Chief Investigator: Professor Jane Blazeby

Study coordinator: Dr Graziella Mazza

Some descriptionBy-Band-Sleeve twitter


The CIPHER Study (Phase B)

Funder: NIHR/HTA 

Status: Set Up

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.


Contact Information

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

Assistant Trial Coordinator: Holly Mckeon



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: Set up 

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



Effectiveness, cost effectiveness and safety of gabapentin versus placebo as an adjunct to multimodal pain regimens in surgical patients: A placebo controlled randomised controlled trial with blinding (The GAP study)

Sponsor: NIHR/HTA

Sponsor: University Hospitals Bristol  

Status: Set Up 

About 4.5 million people undergo surgery each year in the UK. Most patients experience pain after surgery.  Good pain control is essential to recovery. Opioids (e.g. morphine) are typically prescribed to control the pain. Opioids are effective but carry side effects such as sleepiness, sickness and low blood pressure. These side effects prevent recovery and keep patients in hospital for longer. Gabapentin is an alternative medication that doctors are increasingly prescribing for pain relief after surgery. We don’t know whether giving gabapentin alongside opioids and other drugs improves pain control, leading to fewer side effects overall and a quicker recovery.  This is the question the GAP study is aiming to answer.

The GAP study will recruit patients having heart, thoracic (e.g. lungs) or abdominal surgery. Patients who agree to participate will be allocated by chance to receive either gabapentin or identical-looking “dummy” pills (placebo) just before their operation and for two days following their operation. We will collect information on pain experienced after surgery, the amount of opioid medications used, any complications patients experience and how long patients stay in hospital. We will also collect information on quality of life and chronic pain experienced 4 months after surgery.



Contact Information

Chief Investigator: Professor Chris Rogers

Study coordinator: Sarah Baos



Randomised Oesophagectomy: Minimally Invasive or Open

Funder: NIHR/HTA 

Sponsor: University Hospitals Bristol 

Status: Recruiting 

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.

Publication: 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

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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



Video Assisted Thoracoscopic Lobectomy Versus Conventional Open Lobectomy For Lung Cancer, A Multi-Centre Randomised Controlled Trial With An Internal Pilot:

The VIOLET Study

Funder: NIHR/HTA 

Sponsor: Royal Brompton and Harefield NHS Foundation Trust 

REC Number: 14/LO/2129

Status: Recruiting

Lung cancer is the leading cause of cancer death worldwide and survival in the UK remains amongst the lowest in Europe. Surgery is the main method of managing early stage disease with over 5000 resections being performed for primary lung cancer within the UK in 2010. Of these, the majority (75%) involved surgical excision of the pulmonary lobe containing the tumour (lobectomy), which is the standard treatment strategy for patients with early stage non-small cell lung cancer.

This type of surgery can be undertaken via traditional open surgery or a form of keyhole surgery called video assisted thoracoscopic surgery (VATS). Both ways of performing the operation are currently used within the NHS and both aim to remove the lobe of the lung containing the tumour. However, at present, we do not know which offers the best treatment and recovery for patients.

Therefore, the aim of the VIOLET study is to generate high quality evidence to compare clinical and patient-reported outcomes between VATS and open surgery in a randomised controlled trial (RCT). A well designed and conducted RCT comparing the effectiveness and cost-effectiveness of VATS and open surgery is urgently needed to inform current NHS practice, health policy and individual surgeon and patient decision-making.

The VIOLET study will involve 500 patients recruited from several hospitals across the UK. The study design includes an internal pilot phase to ensure deliverability of the full RCT.

The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA, NIHR, NHS or the Department of Health.

Contact Information

Chief Investigator: Mr Eric Lim, Consultant Thoracic Surgeon, Royal Brompton Hospital

Study coordinator: Lucy Dabner


Further information can be found on Cancer Research UK