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
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.
Improved prosthetic meshes for tissue reconstruction (coming soon)
Remote patient monitoring (coming soon)
Early detection of sepsis and acute organ failure (coming soon)
Intra-operative imaging (coming soon)
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)
What is the clinical and cost-effectiveness of new technologies developed to assist the monitoring and management of diabetes? And in which patient groups are they most effective? Identified by NHS England Research Needs 2018
NHS England Research Needs 2018
These unmet needs have been identified by NHS England’s six national priority programmes and provide an early signal of potential research requirements across the wider clinical portfolio.
Is there a valid population risk stratification tool using existing NHS health deficit data which permits accurate population sub-stratification to predict health and social care utilisation risks and key health outcomes including mortality for all adults?
Are there cost effective wearable technologies capable of detecting adult human frailty which predict risk of onset, permit reliable diagnosis of frailty by degree and are capable of tracking frailty progression over time?
The initiative builds on the work of the NIHR Colorectal Therapies Healthcare Technology Co-operative (2013 – 2017).