The NIHR Surgical MedTech Co-operative supports the development of medical technologies in the fields of colorectal, vascular and hepatopancreaticobiliary (liver, gall bladder and pancreas) surgery 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.
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 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.
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.
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.
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.
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.
ColorectalComplications of Stoma
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.
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.
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.
Biosensors for incontinence detection (coming soon)
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: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.
What are the risk factors? Smoking, Diabetes, Hypertension, High Cholesterol, Diet and Weight
Current treatment: See NICE guideline CG147
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
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.
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.
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 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.
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.
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.
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.
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.
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.
What is the Surgical MIC going to do about it: We will focus on prevention and good early detection.
Focus of research must be on methods of preventing and treating vascular disease
The initiative builds on the work of the NIHR Colorectal Therapies Healthcare Technology Co-operative (2013 – 2017).