Unmet Clinical Needs

The NIHR Surgical MedTech Co-operative supports the development of medical technologies in the fields of colorectal, vascular, hepatopancreaticobiliary (liver, gall bladder and pancreas) and neurosurgery to improve healthcare and quality of life for patients.  We are hosted by the Leeds Teaching Hospitals, the second biggest healthcare provider in the UK, working closely with the University of Leeds, a leading UK University with strengths in biomedical research.

There are important challenges that cut across General Surgery. “Safer Surgery” is a priority area of national (UK National Patient Safety Agency) and international (WHO Safer Surgery Saves Lives) importance. 30% – 50% of patients undergoing major abdominal surgery suffer a complication, inflating the cost of care by ~6-fold and causing long-term physical, psychological, and financial consequences. Surgical site infection and anti- microbial resistance are high on the national agenda, and there is a real need to improve outcomes for the most vulnerable patients undergoing emergency surgery.

One of the most significant advances in surgical practice has been the introduction of minimally invasive therapies (laparoscopic and endoluminal), with benefits for patients in terms of quicker recovery, and healthcare providers in terms of efficiency savings.  Although there is no shortage of surgical innovation, few devices make it into clinical practice; only 9.8% of surgical innovations are translated to first-in-man studies, with ~1% being widely adopted. Early clinical involvement has been identified as the biggest obstacle to successful translation.

By working with our key stakeholders, the NIHR Surgical MIC will address many of the important unmet surgical needs and provide the expertise and resource needed to translate new technologies into patient benefit.


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How we prioritise our work


We prioritise our resources and funding according to the unmet clinical needs identified by our partners, patient and public groups, and healthcare professionals.  These are areas that:

  • represent real challenges which need to be addressed.
  • have the greatest potential for improving patient care.
  • would resolve uncertainty for clinicians and other healthcare professionals.

Unmet clinical needs identified to date:  (click on each for more detail):

Cross cutting unmet needs (they apply to all areas of surgery)

Anastomotic Leak
What is an anastomotic leak: a leak of luminal contents from a surgical join between two hollow viscera.What is the incidence: 1 percent to 30 percent dependent on type of operation and patient factors.

What are the risk factors: i) technical factors e.g. poor blood supply to bowel ii) patient factors (age, immunosuppression, diabetes).

Current treatment: if it is a contained leak – radiological drainage procedure; a large leak could result in a laparotomy with take down of anastomosis and formation of stoma.

Outcomes: High morbidity. Multi-organ failure. Mortality ~40 percent

What is the Surgical MIC going to do about it:  We will focus on prevention of leaks by more reliable anastomosis and early detection of anastomotic leak to minimize morbidity.

Enhanced Postoperative Recovery
Why is this important? Cost of hospital stay: ~£500 per day

What contributes to long hospital stays? Obstacles to recovery include: i. delayed recovery of normal function ii. pain iii. impaired nutrition iv. immobility v. complications (chest infection, wound infection) vi. lack of social care.

Current situation: Minimally invasive surgical techniques reduce trauma and facilitate quicker recovery with fewer complications

So, what is the problem? Ageing population presents a real challenge

What is the Surgical MIC going to do about it:  We will focus on better devices for minimally invasive surgery, improved postoperative pain control, therapies and interventions to reduced postoperative complications, improved postoperative and rehabilitation monitoring (telehealth) for detection of complications v. personal assist devices for rehabilitation, and understanding the role of nutrition in recovery.

Questions patients want answered:

  • How do we stop patients developing chronic pain after surgery?
  • How can we improve recovery from surgery for elderly patients?
  • How can pre-operative exercise or fitness training, including physiotherapy, improve outcomes after surgery?
  • Improving communication between the teams looking after patients throughout their surgical journey.
  • How can we improve patient recovery from surgery?
  • How can pre-operative assessment for adults be improved?
  • How can we reduce complications (adverse events) after surgery?
  • What is the best way to assess hepatic reserve pre-operatively? Could novel technologies for the assessment of liver function increase the pool of patients suitable for surgical management of primary liver tumours?
  • What can be done to reduce the rate and risk of pancreatic leaks post-Whipples procedure?
  • Methods of preventing bacterial sepsis and wound complications after liver transplantation
Early Detection of Disease
Why is this important?  Early disease diagnosis results in improved patient outcomes, especially when it comes to bowel, liver and pancreatic cancers.

So, what is the problem? Some screening methods have low uptake by patients due to invasiveness of procedure, and other factors.

What is the Surgical MIC going to do about it:  We will focus on improved patient compliant screening for difficult-to-diagnose conditions.

Questions patients want answered:

  • Early identification of people at risk of liver disease
  • Imaging modalities to distinguish focal liver lesions
  • Imaging modalities to confirm diagnosis and distinguish nature of gallbladder polyp
Incisional Hernia
What is an incisional hernia?  It is a protrusion of viscera through a defect in the abdominal wall through a previous surgical incision.

What is the incidence?  15-20 percent of all abdominal wounds. In UK 600,000 patients undergo abdominal surgery/year Up to 120,000 incisional hernias.

What are the risk factors?  i)Patient factors: e.g. nutrition, hypoxia, chronic lung disease, diabetes, obesity ii) Emergency surgery iii) Wound infections iv) surgical technique.

What are the complications?: incarceration (15 percent), strangulation (2 percent) requiring emergency surgery

What is the current treatment?  Surgical repair with mesh reinforcement. Recurrence rate is 15-25 percent, depending on technique and experience.

What is the healthcare burden?  10,000 repairs per year in UK Large untreated population Significant risk of emergency admission and operation Cost of readmissions and complex re-operations

What is the Surgical MIC going to do about it?  i) improved methods of wound closure or re-enforcement to prevent hernias. ii) Definitive surgical treatment for incisional hernias that prevents recurrence.

Next Generation Surgical Instruments

Why is this important?  The last remaining deficit to the laparoscopic surgeon is the ability to directly feel consistency and texture within tissues.

What is the problem?  1.Excessive force applied to tissues contributes to post-operative ileus (15 to 20 percent incidence, prolonged hospital stay).  2.Extensive dissection in major abdominal surgery leads to a systemic inflammatory response (10 percent admiMed to ICU aPer major abdominal surgery, 12 percent mortality)

What needs to happen?  There is a need for real time, intra-operative information: i.Delineate normal and diseased tissue ii.Identify presence of blood vessels Enhanced intra-operative information: i.Assess metabolic and biological activity of diseased tissue. ii.Measure oxygenation – to assess (e.g.) tissue viability, wound healing and risk of anastomotic leak.

What is the Surgical MIC going to do about it?  Better devices for minimally invasive surgery to i) reduce the trauma of surgery and ii) provide more intra-operative information to the surgeon.



3 main areas of high healthcare burden for colorectal disease

– Cancer – 4th most common cancer; 40,000/yr
– Colitis – 1 in 250 population; young & productive
– Continence – 3% – 5% population; 2nd commonest cause for admission to nursing home

Therapies are aimed at resection of diseased tissue and/or restoration of normal function

Complications of Stoma
What is a stoma?  A stoma is an opening of the gut onto the abdominal wall.  A consequence of gastrointestinal surgery when bowel continuity cannot be restored, is unsafe to restore, or would result in poor function.

What types of stoma are there?  A stoma can be temporary or Permanent. An Ileostomy is a stoma of the small bowel/intestines, and a Colostomy is one to the large bowel/intestines.

What is the incidence?  There are approx 20,000 stomas created per year. Over 100,000 people with stomas in UK

What is the healthcare burden?  The cost of a colostomy over 5 years = £28,000. Annual appliance budget for UK’s 60,000 colostomates is £250 million

Complications associated with this: herniation (30 percent – 50 percent), dehiscence, prolapse, retraction, stenosis, dermatitis, bleeding

What is the Surgical MIC going to do about this?  We are going to work on improved methods of stoma formation to prevent complications and improve quality of life.

Postoperative Ileus
What is Postoperative Ileus?  This is the transient loss of bowel motility. Prolonged ileus (>72hrs) is the most common complication of major abdominal surgery.

How common is this?:   15-20 percent of all major abdominal procedures, including 30,000 colorectal resections in UK each year.

What are the side effects?  i) nausea, vomiting, pain delayed hospital discharge ii) poor nutrition / need for IV nutrition iii) more complications

Can we prevent it?  Laparoscopic surgery and enhanced recovery strategies have a limited benefit in time to return to function (~1 day).

What is the current treatment:   Supportive. No proven benefit from prokinetic drugs or laxatives. Opioid blocking drugs being evaluated may have a limited benefit

What is the Surgical MIC going to do about it?  We will prioritise the i. prevention of POI by decreasing trauma of surgery or selectively modifying inflammatory response ii. prevention of effect of painkilling drugs on bowel motility iii. identification of patients most at risk of prolonged POI iv. provision of effective means to re-stimulate bowel motility.

Stratification of Colorectal Cancer
What is this?  Large and overlapping treatment groups for colorectal cancer, but several subgroups exist for which personalised treatment is available if patients can be accurately identified.

Why is this important?  Over-treating early colorectal cancer: Radical resection carries three to five percent mortality and risk of permanent stoma, but is indicated even for patients with early disease to capture the 8 to 23 percent with involved lymph nodes.  Under-treating Stage II colorectal cancer: Majority deemed to be ‘nodenegative’ and have curative resection without chemotherapy – but 25 to 30 percent will develop distant metastases.  Pre-operative radiotherapy for Stage III rectal cancer: Not possible to separate which patients will benefit most from short course radiotherapy or from long course chemo-radiotherapy.

What is the current practice?  Standard staging system creates broad treatment groups. Molecular and metabolic differences in tumours can only be detected with time consuming and expensive techniques.

What is the Surgical MIC going to do about it?  We will focus on stratification of colorectal cancer patients and tumours into biological and metabolic subgroups in order to offer personalised treatment strategies to individual patients.

Faecal Incontinence
Visit the IMPRESS section of our website


Real-time/Intra-operative disease localisation

Why is this important? Location varies with patient position at surgery

Current treatment: Surgeons currently use India ink tattoo which diffuses and highlights lymphatic spread of disease by exciting an inflammatory response; however, this can be inaccurate.

Real time lymph node diagnosis

What is this? Gastrointestinal cancers spread in the following ways:

  • Lymphatics: regional lymph nodes
  • Blood vessels: liver
  • Exfoliation: abdominal cavity

Lymph node staging is used to determine the radicality of surgery and provides prognostic information for the surgeons.

Current treatment: CT scans are currently used and they are ideal for growths of >5mm in diameter, growths clustering in groups of three or more, growths with irregular borders, however accuracy is ~50%.  Clinical benefit in breast cancer, melanoma etc. But mixed results in colorectal cancer.

Elimination of minimal residual disease

Why is this important? Microscopic disease is the main cause of cancer recurrence.

Current treatment: Heated intraperitoneal chemotherapy is being used however this is associated with high morbidity & cost, and benefits are controversial.

Detection of disease recurrence at early stage

Why is this important? 10% – 15% local recurrence rates and these are not amenable to surgical resection if detected late.

Current treatment: Conventional chemotherapy, radiotherapy or palliative care.  There is a need for devices to treat/palliate disease recurrence.

 Quantifying fluorescence perfusion

Why is this important? A leak of luminal contents from a surgical join between two hollow viscera is one of the most feared complications in surgery with an incident rate of between 1% – 30%.  This results in high patient morbidity, poor quality of life, high rates of permanent stoma and increased cancer recurrence.

Current treatment: Recently, near-infrared fluorescence imaging has been used intraoperatively to visualize the blood supply at the region of interest.  Indocyanine green fluorescence imaging is used to evaluate intestinal perfusion prior to anastomosis.

Quantifying disease severity

Why is this important? This is important for patients with Inflammatory Bowel Disease (i.e. Crohn’s Disease, Ulcerative Colitis, etc) as current methods are invasive.

Detection of early malignant change

Why is this important? This is important for patients with Inflammatory Bowel Disease (i.e. Crohn’s Disease, Ulcerative Colitis, etc) as current methods are invasive.

Improved pattern recognition systems

Why is this important? Gaps in colonoscopy skills among endoscopists, primarily due to experience, have been identified, and solutions are critically needed. The development of real-time detection systems for colorectal neoplasms will significantly reduce the risk of missed lesions during colonoscopy.

Improved endoluminal therapies

Why is this important?  Endoscopic submucosal dissection (ESD) is accepted as a minimally invasive treatment for colorectal cancer. However, due to technical difficulties and an increased rate of complications, ESD is not widely used in the colorectum. In some cases, endoscopic treatment alone is insufficient for disease control, and laparoscopic surgery is required.

Image registration, motion compensation, laser guidance

Why is this important? There is a growing demand to remove early precancerous/cancerous tumours by endoscopic means. Existing procedures use relatively cumbersome electrical cutting devices to apply heat to the tissue are challenging to perform due to restricted access and a lack of fine control for the surgeon. In some cases, it is not possible to remove colonic lesions due to them occupying sites inaccessible to “forward facing” endoscopic excision methods. This results in a non-ideal procedure sometimes resulting in serious complications such as bowel perforation.


Top 10 Clinical Challenges for Liver Surgery
Challenges before surgery

  • Accuracy of diagnostic imaging
  • Assessing liver functional reserve
  • Determining fitness for surgery

Challenges during surgery

  • Parenchymal transection and bleeding
  • Limited utilisation of laparoscopic liver surgery
  • Laparoscopic and robotic instrumentation
  • Integration of treatment modalities

Challenges after surgery

  • Post operative pain control
  • Wound infection
  • Incisional hernias


Improving certainty about organ function following transplantation
What reduces certainty? While there is some validated model that can be used to predict the organ function, these models are relatively crude and surgeon’s confidence in them varies.  Donor and organ characteristics that are associated with poor outcomes are well described but much still depends on the judgement and experience of the surgeon.  More and clearer information would help the surgeon decide how best to use donated organs.

What are the risk factors: Donors after brain death provide, on average, one more organ for transplantation than donors after circulatory death.  Donor characteristics are continuing to change:  donors are older, more obese, and less likely to have suffered a trauma-related death, all of which have adverse effects on transplant outcomes.  The length of time that elapses between a liver being removed from the donor to its transplantation into the recipient is called the cold ischaemia time (CIT).  Generally, the shorter this time, the more likely the liver is to work immediately and the better the long-term outcome.

Current treatment: Reasons for the medical unsuitability of an organ include infections, tumours, anatomy and disease.  Non-medical reasons include donor size and donor instability.  Clinical unsuitability of an organ encompasses poor perfusion, prolonged ischaemia, past history of the donor and, in the case of pancreases for islet usage, insufficiency of viable islet yield.

What is the Surgical MIC going to do about it:  Biomarkers and histological characteristics are of help but there are a few valid and easily accessible biomarkers currently available and histological assessment of retrieved organs is not readily accessible to surgeons.

Questions patients want answered:

  • How do you reduce ischaemia reperfusion injury in liver transplantation and liver resection?
Cholecystectomy pancreatitis

Why is this important? The pancreas is an abdominal organ that secretes several digestive juices which help in the digestion of food. It also lodges the insulin‐secreting cells which maintain the blood sugar levels. Acute pancreatitis is a sudden inflammatory process in the pancreas which might involve nearby organs or may have an effect on other organ systems including blood circulation. Depending upon the presence of organ failure (such as kidneys, lungs or blood circulation) and the presence of local complications such as fluid collection around the pancreas, pancreatitis can be classified as severe acute pancreatitis or mild acute pancreatitis.

There is considerable controversy regarding how long one should wait after a sudden attack of acute gallstone pancreatitis before removing the gallbladder.

What are the risk factors: People with severe pancreatitis have organ failure or local complications, or both, while those with mild pancreatitis do not have such features. The two main causes of acute pancreatitis are gallstones and alcohol, accounting for more than 80% of acute pancreatitis.

Current treatment: Removal of the gallbladder (cholecystectomy) is the definitive treatment for prevention of further attacks of acute gallstone pancreatitis if the person is suitable for surgery. Laparoscopic removal (key‐hole surgery) of the gallbladder is the currently preferred method of cholecystectomy with more than 99% of patients recovering completely without any major ill health.

Image ablation

Why is this important? Despite the significant improvement of knowledge and technologies in tumour treatments, pancreatic tumour remains a complex disease still characterised by a poor prognosis.  Pancreatic tumour remains a challenging issue in the medical field. Despite the improvements that are occurring, pancreatic cancer is still burdened by poor prognosis and the gold standard for treatment when possible is surgery.

What are the risk factors:  Unfortunately, less than 20% of patients are eligible for pancreatectomy at the diagnosis; the remaining patients are treated with systemic therapy that leads to a 5-years survival less than 5%.

Current treatment: Surgery, radiotherapy or other minimally invasive procedures

What is the Surgical MIC going to do about it:  Image guided ablations are gaining increasing attention in the current clinical practice providing reduced invasiveness, good outcomes and low morbidity in the treatment of several different tumours (e.g., liver, kidney, lung).  We shall explore their application for pancreatic tumours.

AI imaging ablation / interpretation

Why is this important?  Outcomes of hepatobiliary and pancreatic (HPB) surgery have improved tremendously with reduced postoperative mortality from 20% to less than 3% and 5%-6% for major liver and pancreatic surgery, respectively. Such an improvement has been attributed to more sophisticated pre-operative imaging and improved peri-operative care, progressive surgical techniques with a better anatomical understanding of anatomy, technological advancement of intra-operative instrumentation, early identification, and management of complications.

However, procedures remain technically complex, requiring careful pre-operative planning, intra-operative execution from experienced surgeons, anaesthetists, nursing staff, and longer operative hours. The postoperative morbidity remains high at 20%-30%, and mortality rates for some of the more complex resections is reported to be as high as 10%.

Artificial Intelligence (AI) has been investigated for its role in predictive population risk stratification and clinical decision support systems.  Most of the uses of AI are based on machine learning, which is a technique that can automatically learn, recognise specific patterns, and make useful decisions based on the available data. Deep learning is part of the same technique, which replicates the neural network of the human brain for data analysis. Integration of such processes into the various aspects of delivery of HPB surgery will allow improving oncological and post-operative outcomes.

What are the risk factors: Hilar cholangiocarcinoma usually presents in an advanced stage when the caudate lobe and hilar structures are already invaded. These patients require radical resection with hepatectomy, associated with significantly increased mortality of 10%-15% and a significantly higher postoperative morbidity of up to 40%.

Another benefit of 3D reconstruction is the accurate stereoscopic assessment of portal vein anatomy and determining the line of parenchymal transection and planning portal vein reconstruction. Other studies also reported similar benefits including reduced amount of intra-operative bleeding with the use of preoperative 3D reconstruction

Current treatment: Currently, most HPB surgeons use two-dimensional (2D) images from computed tomography (CT), magnetic resonance imaging (MRI) scans to evaluate the position of a lesion, and its relationship to the surrounding structures in the preoperative planning. However, the 3D cognitive interpretation of spatial structure of the tumour and its relation with surrounding structures can be misjudged at times.

What is the Surgical MIC going to do about it:  Validate and evaluate AI based technologies for surgery.

Wound closure

Why is this important? In surgical practice, an incision is the basic step that gains access to the operative field. However, the incision itself is a trauma, disrupting the integrity of local skin tissue, damaging the local protective barrier, promoting microbial invasion and growth, and causing further complications, of which the most common is wound infection.

As surgical techniques have advanced and hospital infection control has progressed, the rate of incision healing has significantly improved, yet incision infection still occurs for many reasons. The current rate of surgical wound infection is as high as 8.4%, and the treatment of infected incision remains an issue for surgeons[

What are the risk factors:  Surgical Site Infections (SSIs) after hepatopancreaticobiliary (HPB) cancer surgery, can cause delay for patients receiving optimally-timed adjuvant chemotherapy.

Current treatment: Postoperative wound infections can be handled
by secondary suturing or the butterfly bandage method, often after several weeks of open drainage and dressing.

These traditional methods have many drawbacks; use of the butterfly bandage prevents continuous observation of the wound condition, the tape itself cannot be guaranteed to be sterile, and the adhesion strength of tape
is often gradually reduced during wound closure.  More importantly, the butterfly bandage exerts uneven forces and cannot gradually diminish the tension on an incision wound.

Multi imaging

Why is this important? Coming soon

Patient follow up - low cost intervention

Why is this important? Surgical complications, in addition to causing harm to patients, are expensive and can result in dramatically increased healthcare expenditures for patients, hospitals and payers. Reducing complications can improve the quality of care, as well as enhance value by reducing overall costs.  While surgical complications are a major driver of increased health care costs, the association between costs and quality is poorly understood.

What are the risk factors: Hepatopancreatobiliary (HPB) operations are associated with increased perioperative morbidity compared with other general surgical procedures and these complications can subsequently increase the length of stay, delay receipt of adjuvant therapy, and adversely impact patient quality of life.  In addition, HPB complications can be relatively resource intensive and generate costs greater than complications associated with general surgical cases.

Lap cholecystectomy, Transplantation, AI review of pancreatic imaging

Why is this important? Laparoscopic cholecystectomy is the preferred option in the management of gallbladder disease.

Pancreatic cancer carries a poor prognosis with a 5-year relative survival rate of 5.8% (SEER Stat Fact Sheets: Pancreas). At least 80% of patients with pancreatic cancer present with either locally advanced or metastatic disease and are not resectable at the time of diagnosis. Complete surgical resection is the only curative treatment with potential for long-term survival. Accurate staging is essential in treatment planning and in determining appropriate management of patients with pancreatic cancer by selecting patients who can benefit from surgery and identifying patients with non-resectable disease to avoid non-therapeutic laparotomies.

What are the risk factorsLaparoscopic cholecystectomy has advantages over open cholecystectomy, including a shorter hospital stay and an earlier return to normal activities. However, complications after laparoscopic procedures, especially bile duct injuries, have been reported to be more common.  A variety of other problems, including vascular injury, retained gallstones, and abscess formation, may also be encountered after laparoscopic cholecystectomy.

Current treatment:  The correct use of radiologic tests can establish the type and site of postoperative complications, allowing timely intervention. Sonography, CT, ERCP, MR cholangiopancreatography (MRCP), and radionuclide imaging all have a role to play in evaluating the postoperative patient. These investigations are often complementary and the primary imaging technique to be used will vary depending on the clinical problem faced.

AI assessment of liver tumours

Why is this important?  Coming soon…

Virtual prevention, AI post-operative recovery

Why is this important?   Coming soon



Immersive Technologies

Why is this important? Immersive technologies (virtual and augmented reality) have been shown to engage people in their health and wellbeing. Neurosurgery has a long track record of being at the cutting edge of technology (examples include frameless stereotactic navigation, intra-op ultrasounds and MRI, robotics, real-time neurophysiology). It is therefore well placed to integrate and implement immersive technology into the peri-operative patient journey and neurosurgical training.

What is the Surgical MIC going to do about it:  The focus will be on patient education of complex neurosurgical concepts, pre- and intra-op navigation and surgical planning tools, post-op neurorehabilitation, and enhanced neurosurgical training using virtual and mixed reality environments to complement cadaveric and simulation teaching.

Bespoke Patient Care

Why is this important?  Brain tumours have clear individual and societal impacts (shortened life expectancy, loss of working years, loss of independence, decreased QoL). Each patient with a brain tumour is unique due to the nature of the disease on such an eloquent host organ. This inherent patient heterogeneity (couple with intra-tumoural heterogeneity) means that a bespoke patient-facing approach is needed.

Enhanced Detection of Neurosurgical Pathologies

Why is this important?  Common neurosurgical pathologies such as brain tumours and chronic degenerative conditions benefit from enhanced imaging and detection, facilitating earlier diagnosis and better-informed management. In the case of infiltrating brain tumours, the ability to differentiate normal from diseased tissue in real-time can inform extent of resection and stop/go decisions intra-operatively. Real-time histology could also maximise the yield of diagnostic tissue and minimise the risk of a repeat procedure. Machine-learning algorithms can longitudinally detect brain tumour progression and inform prognosis and decision making for timing of intervention. Enhanced imaging of cervical degenerative pathology can inform choice of surgical procedure.


The Vascular Society of Great Britain and Ireland’s Research Committee has recently completed a national multidisciplinary Delphi process and are in the process of setting up national priority setting partnerships for the following research priorities.  Focus of research must be on methods of preventing and treating vascular disease.

What leads to amputations?

There are approximately 5000-6000 major lower limb amputations undertaken each year in the UK. The path to an amputation usually begins with an ulcer. Ulcers can occur in patients with diabetes, peripheral arterial disease, venous disease and lymphoedema.

What are the risk factors?  Diabetes is the most common cause of non-traumatic limb amputation, with diabetic foot ulcers preceding more than 80% of amputations in people with diabetes.

Current treatment: The whole pathway has three areas: foot screening, foot protection for those identified through screening to be at high risk of foot disease, and a multidisciplinary foot care service for those with active diabetic foot disease. Foot ulcers in patients without diabetes have no clear pathway of care. However, these patients are at risk and many have critical limb ischaemia.  Limb salvage interventions aim to avoid the large community healthcare costs of amputation which are greatly in excess of those following successful revascularisation.

Outcomes: High operative mortality rates

What is the Surgical MIC going to do about it?  We will focus on technologies that prevent amputations and those that offer early detection of limb ischaemia.

Peripheral Arterial Disease
What is this?  Peripheral arterial disease (PAD) is when your arteries begin to narrow. It’s a common problem that affects 9% of the population, but will only cause symptoms or problems in a quarter of those people. Peripheral Arterial Disease commonly affects the leg arteries with 20% of people over 60 years of age estimated to suffer with PAD. The symptoms are cramping in the legs on walking, intermittent claudication (4% of patients > 60 years of age) and 20% of these will deteriorate and develop critical limb ischaemia.

What are the risk factors? Smoking, Diabetes, Hypertension, High Cholesterol, Diet and Weight

Current treatment: See NICE guideline CG147

Surgical procedures:  Angioplasty and Stenting; Femoral Endarterectomy and Peripheral Arterial Bypass Graft

Outcomes:  Critical limb ischaemia (CLI) is the advanced stage of peripheral arterial disease. Once a patient has developed CLI, the blood supply to the extremities is no longer adequate to sustain the basic metabolic needs of the tissue. This results in ischaemic rest pain, ulceration and gangrene. CLI has a negative impact with 1-year amputation rates of approx. 12% and mortality of 50% at 5 years and 70% at 10 years. It is recognised as an urgent condition and, depending on the clinical presentation, may require urgent admission.

Acute limb ischaemia (ALI) occurs when the circulation is suddenly reduced by an embolus (a clot, often from the heart) or thrombosis within the limb arteries. This is more common in the elderly, and the rate of hospital admissions has risen significantly from 60.3/100,000 population in 1999 to 94.3/100,000 in 2011. In some cases, surgery to remove the clot is required, or the clot can be “dissolved” by thrombolysis, an endovascular approach.

What is the Surgical MIC going to do about it: We will focus on technologies that prevent leg amputation due to peripheral arterial disease, provide symptom relief from PAD and venous disease

Venous Leg Ulcers
What are they? Chronic leg ulcers are non-healing wounds, often occurring on the lower part of the leg and usually due to an underlying vascular problem (venous and/or arterial disease). Chronic leg ulcers often persist for many months and once healed, are at high risk of recurrence. According to VSGBI there are approximately 150,000 people in the UK with active leg ulcers.
What are the risk factors: Chronic venous hypertension is the most common cause of leg ulceration, accounting for >70%. An increasing ageing and overweight population.

Current treatment: Patients are often managed in community healthcare settings. For more information see NICE guidance 2013.

Outcomes: Chronic leg ulceration is an enormous cause of patient distress and expense to the NHS.

What is the Surgical MIC going to do about it: We will focus on technologies that promote healing of venous leg ulcerations and promote cardiovascular health.

Abdominal Aortic Aneurysm
What is an abdominal aortic aneurysm?  An abdominal aortic aneurysm (AAA) is a bulge or swelling in the aorta, the main blood vessel that runs from the heart down through the chest and tummy. This occurs when the wall of the abdominal aorta weakens and stretches, caused by atherosclerotic degeneration. The more aorta dilates, the weaker it gets, increasing the risk of rupture.

What are the risk factors? This is more common in elderly men.
Current treatment: A national screening programme is in place to detect AAAs prior to rupture. See guidelines for AAA repair. Elective or emergency open surgery to repair an AAA is a major operation with significant morbidity and mortality. An alternative treatment in selected cases is endovascular aneurysm repair (EVAR) using a covered stent graft introduced from the groin, an operation that is less stressful for the patient but not all patients have an aneurysm that is anatomically suitable for EVAR using current technology.

Surgical proceduresEndoVascular Aneurysm Repair (EVAR), Open Aneurysm Repair, Thoracic Stenting

Outcomes: Rupture of an aneurysm into the abdominal cavity is fatal if untreated – emergency open or endovascular repair is the only possible treatment. In hospital mortality remains high at 30 – 40%, total overall mortality (including prehospital deaths) is about 85%.

What is the Surgical MIC going to do about it: We will focus on technologies that prevent deaths from AAA and dissections.

Carotid Artery Intervention
What is a carotid artery? The carotid arteries are the blood vessels that carry oxygen-rich blood to the head, brain and face. They are located on each side of the neck. You can easily feel them by placing your fingers gently either side of your windpipe. The carotid arteries supply essential oxygenated blood to the large front part of the brain. This part of the brain controls thought, speech, personality as well as our sensory (our ability to feel) and motor (our ability to move) functions.

Carotid artery disease is the narrowing or blockage of these arteries (stenosis) due to plaque build-up (atherosclerosis). The plaque can then crack, and develop an irregular surface, which is when it begins to cause problems. If a piece of plaque or a blood clot breaks off from the wall of the carotid artery it can block the smaller arteries of the brain. When blood flow to the brain is blocked, the result can be a transient ischemic attack (TIA), which temporarily affects brain function, or a stroke, which is permanent loss of brain function.

Common symptoms of TIA include brief attacks of weakness, clumsiness, numbness or pins and needles of the face, arm or leg on one side of the body.

What are the risk factors?  Some are fixed, such as being male, having a family history of stroke or angina, or getting older. Others can be modified such as smoking, high cholesterol, high blood pressure or diabetes. If you already have peripheral arterial disease (PAD) or coronary heart disease you are at higher risk of carotid disease and stroke. Furring of the arteries is a normal part of the ageing process; however, it does need to be monitored throughout the body, especially around major arteries and the heart where it can cause heart attacks and angina.
There is good evidence that patients with symptoms and a >50% stenosis have an increased risk of subsequent stroke

Current treatment: The diagnosis is usually made with an ultrasound scan of the arteries in the neck (duplex), or sometimes after a CT or MR scan. There is good evidence that some patients, usually those with narrowing greater than about 70% of the diameter of the artery, benefit from surgery; carotid endarterectomy.

Surgical proceduresCarotid Endarterectomy, Carotid Stenting

Outcomes: Carotid artery disease is one of the most common causes of stroke. More than half of the strokes occur because of carotid artery disease.

What is the Surgical MIC going to do about it: We will focus on diagnostic and treatment technologies.

Vascular Access
What is vascular access? Vascular patients are susceptible to acute kidney injury (AKI) either as a result of contrast induced nephropathy or following intervention. Patients undergoing haemodialysis require regular access to the circulation to allow withdrawal and return of blood so that it can pass through a dialysis machine at a rate of at least 300ml/min.

What are the risk factors?  Patients with vascular disease often have significant chronic kidney disease and there is the need to minimise the adverse effect of surgical intervention on renal function.

Current treatment: A national screening programme is in place to detect AAAs prior to rupture. See guidelines for AAA repair. Elective or emergency open surgery to repair a AAA is a major operation with significant morbidity and mortality. An alternative treatment in selected cases is endovascular aneurysm repair (EVAR) using a covered stent graft introduced from the groin, an operation that is less stressful for the patient but not all patients have an aneurysm that is anatomically suitable for EVAR using current technology.

Outcomes: Vascular access can be achieved using a double lumen central venous catheter in the short term, but long-term catheter use is associated with increased infection, higher mortality and central venous stenosis or thrombosis.

What is the Surgical MIC going to do about it: We will focus on technologies for arteriovenous fistula formation.

Venous Disease
What is venous disease? When a clot develops in a deep vein of the limb (leg or arm or pelvis) we call it a Deep Vein Thrombosis (DVT). This causes the leg to swell and become painful. The deep veins of the leg may be damaged by the thrombosis and fail to work normally after a DVT. Venous disease commonly causes lower limb swelling and ulceration.

What are the risk factors?  In the deep veins of the leg, if the blood flow is slow, or the vein wall is damaged / diseased or the blood itself is more prone to clot (thicker blood) then a clot forming in the vein becomes more likely? Slower blood flow occurs when people are immobile due to illness or injury, when travelling in restricted positions for many hours, after surgery, with dehydration, increasing age and obesity. The vein wall may be more prone to a clot after injury, limb surgery, previous DVT, infusion with drugs and fluids that damage the vein lining. The blood can be more likely to clot due to medications, (hormones, the pill) in patients with cancer and in conditions where the blood count is raised (polycythaemia, leukaemia). Some patients have inherited conditions with abnormal clotting factors and are more prone to DVT as a result.

Current treatment: With thinning of the blood, the clotting process can usually be controlled. Over 3-6 months the clot in the vein is slowly resorbed and often the vein “recanalises” so that blood can flow through it again. 10-20% of veins may remain blocked. The valves in the veins are often damaged in this process, and the deep veins often do not work as efficiently as normal after a DVT.

There is growing interest in using clot dissolving drugs, and devices within the clotted veins to remove the clot when it first forms. This is called mechanico-lysis. For large extensive clots in the leg and pelvis, there is some evidence that this early removal of the clot can improve the function in the leg veins rather than leaving the clot to slowly be resorbed or leave the vein blocked.

Surgical procedures:  Deep Venous Lysis and Stenting, Endovenous Ablation

Outcomes: If the venous system in the leg fails to work normally the pressure in the leg veins rises. This damages the circulation in the lower leg particularly around the ankle leading to swelling, discomfort, skin changes and eventually it can cause ulceration.

What is the Surgical MIC going to do about it: We will focus on prevention of leaks by more reliable anastomosis and early detection of anastomotic leak to minimize morbidity.

Diabetic Foot Problems
What are diabetic foot problems? People with diabetes may have a reduced nerve functioning due to peripheral diabetic neuropathy. This is when the nerves that carry pain or sensation to and from the feet do not function well, so stepping on something sharp, wearing tight shoes or sustaining a cut can go unnoticed leading to diabetic foot ulcers. Narrowed arteries (atherosclerosis) can also reduce blood flow to the feet.

What are the risk factors?  People who have diabetes are more at risk of getting vascular disease because their blood sugar levels have spent prolonged periods of time being poorly controlled and higher than normal. In turn, this affects the lining of the body’s arterial walls, making the inside of the blood vessels more likely to fur-up causing them to narrow (atherosclerosis).
People with Type 2 diabetes are also more likely to have raised triglyceride levels and low HDL cholesterol which also increase the risk of atherosclerosis.
Current treatment: Annual checks often include an inspection of the feet by a trained health care professional. Nerve function and pulses are checked, any change in the shape of the foot is looked for, footwear advice given, and a podiatrist may treat the feet if needed.

Outcomes: In the worst cases, some people with diabetes may have to have an amputation as the result of an ulcer.

Research priorities in diabetic foot disease

What is the Surgical MIC going to do about it: We will focus on prevention and good early detection.




The initiative builds on the work of the NIHR Colorectal Therapies Healthcare Technology Co-operative (2013 – 2017).