Hughes abdominal closure versus standard mass closure to reduce incisional hernias following surgery for colorectal cancer: the HART RCT.

BACKGROUND: Incisional hernias can cause chronic pain and complications and affect quality of life. Surgical repair requires health-care resources and has a significant associated failure rate. A prospective, multicentre, single-blinded randomised controlled trial was conducted to investigate the clinical effectiveness and cost-effectiveness of the Hughes abdominal closure method compared with standard mass closure following surgery for colorectal cancer. The study randomised, in a 1 : 1 ratio, 802 adult patients (aged ≥ 18 years) undergoing surgical resection for colorectal cancer from 28 surgical departments in UK centres. INTERVENTION: Hughes abdominal closure or standard mass closure. MAIN OUTCOME MEASURES: The primary outcome was the incidence of incisional hernias at 1 year, as assessed by clinical examination. Within-trial cost-effectiveness and cost-utility analyses over 1 year were conducted from an NHS and a social care perspective. A key secondary outcome was quality of life, and other outcomes included the incidence of incisional hernias as detected by computed tomography scanning. RESULTS: The incidence of incisional hernia at 1-year clinical examination was 50 (14.8%) in the Hughes abdominal closure arm compared with 57 (17.1%) in the standard mass closure arm (odds ratio 0.84, 95% confidence interval 0.55 to 1.27; p = 0.4). In year 2, the incidence of incisional hernia was 78 (28.7%) in the Hughes abdominal closure arm compared with 84 (31.8%) in the standard mass closure arm (odds ratio 0.86, 95% confidence interval 0.59 to 1.25; p = 0.43). Computed tomography scanning identified a total of 301 incisional hernias across both arms, compared with 100 identified by clinical examination at the 1-year follow-up. Computed tomography scanning missed 16 incisional hernias that were picked up by clinical examination. Hughes abdominal closure was found to be less cost-effective than standard mass closure. The mean incremental cost for patients undergoing Hughes abdominal closure was £616.45 (95% confidence interval -£699.56 to £1932.47; p = 0.3580). Quality of life did not differ significantly between the study arms at any time point. LIMITATIONS: As this was a pragmatic trial, the control arm allowed surgeon discretion in the approach to standard mass closure, introducing variability in the techniques and equipment used. Intraoperative randomisation may result in a loss of equipoise for some surgeons. Follow-up was limited to 2 years, which may not have been enough time to see a difference in the primary outcome. CONCLUSIONS: Hughes abdominal closure did not significantly reduce the incidence of incisional hernias detected by clinical examination and was less cost-effective at 1 year than standard mass closure in colorectal cancer patients. Computed tomography scanning may be more effective at identifying incisional hernias than clinical examination, but the clinical benefit of this needs further research. FUTURE WORK: An extended follow-up using routinely collected NHS data sets aims to report on incisional hernia rates at 2-5 years post surgery to investigate any potential mortality benefit of the closure methods. Furthermore, the proportion of incisional hernias identified by a computed tomography scan (at 1 and 2 years post surgery), but not during clinical examination (occult hernias), proceeding to surgical repair within 3-5 years after the initial operation will be explored. TRIAL REGISTRATION: This trial is registered as ISRCTN25616490. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 34. See the NIHR Journals Library website for further project information.

Bowel cancer treatment involves surgery for the majority of patients. A complication of this surgery is the formation of a hernia at the site of the incision in the abdominal wall, known as an incisional hernia. The lining of the abdomen, fat or the intestine can squeeze through the gap and form a lump under the skin. An incisional hernia can form any time after surgery and can cause serious complications and pain, and can also affect the patient's quality of life. Surgery to correct incisional hernias is not always successful, so finding a way of preventing them is important. This research compares the traditional way of sewing up the abdomen, where the two sides are brought together in one layer with a continuous thread, with an alternative method called the Hughes abdominal closure method/Hughes repair. In the Hughes repair, a series of horizontal and vertical stitches are arranged to spread the load and ease the tension across the wound. A total of 802 patients from 28 sites in the UK were recruited to the trial. Half of the patients were randomly allocated to have traditional abdominal closure and half were randomised to have Hughes abdominal closure. All were followed up for 1 year after surgery to assess whether or not an incisional hernia had occurred. We also assessed quality of life during follow-up, and we compared the costs and benefits of each procedure to see which option was the better value for money. By comparing the results from the two methods, it was hoped that the best method of abdominal closure to reduce the risk of an incisional hernia occurring would be found. The analysis of the data suggested that the risk of an incisional hernia was no different with either closure method. Furthermore, Hughes abdominal closure was more expensive and provided less value for money than standard abdominal closure.

UroLift for Treating Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: A NICE Medical Technology Guidance Update.

Lower urinary tract symptoms (LUTS) commonly occur as a consequence of benign prostatic hyperplasia (BPH), also known as prostate enlargement. Treatments for this can involve electrosurgical removal of a section of the prostate via transurethral resection of the prostate (TURP), Holmium laser enucleation of the prostate (HoLEP), or prostatic urethral lift using the UroLift system. The UroLift system implants to pull excess prostatic tissue away so that it does not narrow or block the urethra. In this way, the device is designed to relieve symptoms of urinary outflow obstruction without cutting or removing tissue. National guidance recommending the use of UroLift in the UK NHS was first issued in 2015 by the National Institute for Health and Care Excellence (NICE MTG26). We now report on the process to update the economic evaluation of UroLift, leading to updated NICE guidance published in May 2021 (NICE MTG58). The conclusions of the available clinical evidence were mixed and suggested that whilst UroLift improves symptoms over time, this improvement is smaller than that of TURP for symptom severity (IPSS) and urological outcomes. However, UroLift appears to be superior to Rezum for symptom severity and measures of erectile dysfunction and ejaculatory dysfunction. The updated economic model estimated that using UroLift as a day-case procedure for people with prostate of volume 30-80 mL creates a saving of £981 per person compared with bipolar TURP, £1242 compared with monopolar TURP, and £1230 compared with HoLEP.

A Case Study on Reviewing Specialist Services Commissioning in Wales: TAVI for Severe Aortic Stenosis.

The Welsh Health Specialised Services Committee (WHSSC) is responsible for planning, commissioning and funding specialised healthcare in Wales. Investment in new technologies or services is based on clinical and economic evidence, using a consistent and transparent process. This is accomplished in three stages. The first stage is the preparation of a rapid evidence review. This then informs the development or update of the relevant Commissioning Policy. The final stage is to prioritise the Commissioning Policy recommendations against all other new services and interventions, to inform WHSSC's annual commissioning intentions. In 2017, a review was conducted of the WHSSC Commissioning Policy for transcatheter aortic valve implantation for severe aortic stenosis. Prior to this only high-risk patients were eligible for transcatheter aortic valve implantation. The rapid evidence review identified three randomised controlled trials and two economic analyses relevant to the decision problem. Transcatheter aortic valve implantation was generally found to be more expensive and more effective than medical management or surgical aortic valve replacement, with incremental cost-effectiveness ratios around £10,500-£36,000 for inoperable groups and £17,000-£24,000 in high-risk groups. The rapid evidence review, expert advice and stakeholder feedback informed the revision process of the Commissioning Policy for transcatheter aortic valve implantation. This recommended the addition of patients unsuitable for surgical aortic valve replacement and the removal of explicit risk scoring. This recommendation was subject to the prioritisation process (carried out annually). The updated transcatheter aortic valve implantation recommendation was ranked second out of 23 technologies and services competing for additional WHSSC funding. The WHSSC Integrated Commissioning Plan for specialised services in Wales (2019) therefore included funding to support the new criteria for transcatheter aortic valve implantation treatment.

In Wales, specialised health services are selected and funded at a national level by the Welsh Health Specialised Services Committee. Specialised services are provided for small numbers of patients, requiring highly specialised professionals or technologies. When the aortic heart valve becomes narrowed with disease it can be replaced with an artificial valve. This normally requires open surgery, which is risky for some patients, particularly those who are frail. Since 2012, the Welsh Health Specialised Services Committee have funded a less invasive procedure called TAVI (transcatheter aortic valve implantation) for patients who could have open surgery but at a high risk. In 2017, this policy needed updating, thus a new evidence review was conducted. This showed that patients at high risk from open surgery were more likely to survive if they underwent TAVI. Others, for whom open surgery was too risky, were also more likely to survive if they underwent TAVI instead of medication. However, TAVI tended to produce more vascular problems, such as blockages or damage to blood vessels. Transcatheter aortic valve implantation is generally more effective and more expensive than either drugs or open surgery in these patient groups, but is within cost-effectiveness limits often used in the UK National Health Service. As a result of the review, experts recommended that TAVI should be available to more patients, which would require greater levels of funding. Transcatheter aortic valve implantation was ranked as second out of 23 new or updated treatments competing for funding allocations. The Welsh Health Specialised Services Committee therefore published a new Commissioning Plan for TAVI in 2019 that now included patients who are considered too risky to undergo open surgery.

Episcissors-60 for Mediolateral Episiotomy: Evaluation of Clinical and Economic Evidence to Inform NICE Medical Technologies Guidance.

Obstetric anal sphincter injury (OASI) occurs in 2.9% of all vaginal births in the UK and can result in faecal incontinence. Where there is a clinical need for episiotomy, OASI can be minimised by accurate selection of the optimum angle of mediolateral episiotomy. Episcissors-60 are adapted surgical scissors incorporating a guide-limb to help achieve an accurate angle of mediolateral episiotomy. The ability of Episcissors-60 to reduce OASI by preventing inaccurate visual estimates of episiotomy angles was considered by the National Institute of Health and Care Excellence (NICE) as part of the Medical Technologies Evaluation Programme (MTEP). NICE concluded that Episcissors-60 shows promise for mediolateral episiotomy both in terms of clinical effectiveness and potential cost savings, but that there was not enough evidence to support routine adoption into the NHS at this time. NICE MTG47 recommends that key gaps in the evidence including patient-reported outcomes and the addition of Episcissors-60 to care bundles be addressed through research with specific focus on potential equality considerations.

Can we use biomarkers of coagulation to predict which patients with foot and ankle injury will develop deep vein thrombosis?

BACKGROUND: Our aim was to determine whether plasma levels of Tissue Factor (TF), Vascular Cell Adhesion Molecule 1 (VCAM-1), Interleukin 6 (IL-6) or D-dimer after foot and ankle injury could predict which patients would develop deep vein thrombosis (DVT). METHODS: Patients aged 18-60 years with acute foot and ankle injury had venous blood sample to measure TF, VCAM-1, IL-6 and D-dimer within 3 days of injury. Patients had bilateral lower limb venous ultrasound to assess for DVT on discharge from clinic. RESULTS: 21 of 77 patients were found to have DVT (27%). There was no statistically significant association between levels of TF, VCAM-1, IL-6 or D-dimer and subsequent development of DVT. CONCLUSION: Tissue Factor (TF), Vascular Cell Adhesion Molecule-1 (VCAM-1), Interleukin-6 (IL-6) and D-dimer levels were not associated with development deep vein thrombosis in patients with acute foot and ankle injury.

Is it necessary to adjust current creatine kinase reference ranges to reflect levels found in professional footballers?

OBJECTIVE: We aimed to explore the validity of applying current reference ranges of the enzyme creatine kinase (CK) when analysing the medical status of professional footballers and to offer a more functional CK reference range for professional footballers. METHODS: A sample of 27 professional male footballers competing in The Football League Championship was analysed. The single sample Wilcoxon signed-rank test was used to compare the CK distribution of the study group with that of a control group of military personnel reported in the literature. RESULTS: The median values for study group and the published control group were 284 U/L and 124 U/L, respectively (P<0.001) suggesting that the average CK activity of professional footballers is higher than that of the normal healthy military population. CONCLUSION: Ethnicity, sex, age and physical exercise are factors that likely influence CK levels among various populations. From our analysis, we recommend a new 95% reference interval of 64.9 U/L to 1971.7 U/L for professional footballers.

Does thromboprophylaxis reduce symptomatic venous thromboembolism in patients with below knee cast treatment for foot and ankle trauma? A systematic review and meta-analysis.

BACKGROUND: Our aim was to determine the evidence for thromboprophylaxis for prevention of symptomatic venous thromboembolism (VTE) in adults with foot or ankle trauma treated with below knee cast or splint. Our secondary aim was to report major bleeding events. METHODS: MEDLINE and EMBASE databases were searched for randomized controlled trials from inception to 1st June 2015. RESULTS: Seven studies were included. All focused on low molecular weight heparin (LMWH). None found a statistically significant symptomatic DVT reduction individually. At meta-analysis LMWH was protective against symptomatic DVT (OR 0.29, 95% CI 0.09-0.95). Symptomatic pulmonary embolism affected 3/692 (0.43%). None were fatal. 86 patients required LMWH thromboprophylaxis to prevent one symptomatic DVT event. The overall incidence of major bleeding was 1 in 886 (0.11%). CONCLUSIONS: Low molecular weight heparin reduces the incidence of symptomatic VTE in adult patients with foot or ankle trauma treated with below knee cast or splint.

ENDURALIFE-Powered Cardiac Resynchronisation Therapy Defibrillator Devices for Treating Heart Failure: A NICE Medical Technology Guidance.

ENDURALIFE™-powered cardiac resynchronisation therapy defibrillator (CRT-D) devices were the subject of an evaluation by the National Institute for Health and Care Excellence, through its Medical Technologies Evaluation Programme, for the treatment of heart failure. Boston Scientific (manufacturer) submitted a case for the adoption of the technology, claiming that it has a longer battery life resulting in a longer time to CRT-D replacement. Other claimed benefits were fewer complications associated with replacement procedures, fewer hospital admissions, less time spent in hospital and reduced demand on cardiology device implantation rooms. The submission was critiqued by Cedar, an external assessment centre. The submitted clinical evidence showed that ENDURALIFE-powered devices implanted during the period 2008-2010 were superior, in terms of longevity, to other devices at that time. Submitted economic evidence indicated that, because of a reduction in the need for replacement procedures, ENDURALIFE-powered devices were cost saving when compared to comparator devices. Cedar highlighted uncertainty of the applicability of the clinical evidence to devices marketed today. The Medical Technologies Advisory Committee noted that this was unavoidable due to the follow-up time required to study battery life. Clinical experts noted that increased battery life is an important patient benefit. However, centres use devices from multiple manufacturers to negate pressure on clinical services in the event of a major device recall. The clinical and economic evidence showed benefits to the patient, and further analysis requested by the committee suggested that ENDURALIFE-powered CRT-Ds may save between £2120 and £5627 per patient over 15 years through a reduction in the need for replacement procedures. ENDURALIFE-powered CRT-D devices received a positive recommendation in Medical Technologies Guidance 33.

The effect of active toe movement (AToM) on calf pump function and deep vein thrombosis in patients with acute foot and ankle trauma treated with cast - A prospective randomized study.

BACKGROUND: Patients with foot and ankle trauma treated with cast are advised to perform toe movements to prevent venous thromboembolism (VTE). Our aim was to determine the effect of active toe movement on asymptomatic deep vein thrombosis (DVT) and venous calf pump function. METHODS: Patients aged 18-60 years with acute foot and ankle trauma requiring below knee non weight bearing cast were randomized to intervention (regular active toe movement) or control groups (n=100). Patients had bilateral lower limb venous ultrasound to assess for DVT on discharge from clinic. Patients requiring chemical thromboprophylaxis were excluded. RESULTS: 78 completed the study. 27% sustained asymptomatic DVT, with no statistically significant difference in calf pump function or DVT incidence between groups. All DVT's occurred in the injured lower limb. CONCLUSION: Active toe movement is not a viable strategy for thromboprophylaxis in patients with acute foot and ankle trauma treated with cast.

Mobility, proprioception, strength and FMS as predictors of injury in professional footballers.

BACKGROUND: The premise of this study was to investigate if anthropometric variables such as mobility, proprioception, strength and modified Functional Movement Screen (mFMS) could be used as primary indicators of injury risk in an English Championship division football team. This study focused on moderate injuries occurring in the lower extremities, during the 2014/2015 competitive season. METHODS: To differentiate between minor, moderate and severe injuries, this study classified moderate injuries as an injury with an average injury severity of 2-28 days. This study is composed of 4 individual investigations. Each variable was assessed against 2 groups: injured (n=6) and non-injured (n=10). The 2 groups were compiled from the first team, with the criteria that each participant of this study required: full preseason assessment and injury history for the time period, 1 July 2014 to 19 March 2015. A Mann-Whitney U test (0.05% significance) was applied to statistically analyse if each variable showed any variation across the 2 groups. Effect size was estimated with Cliff's d. RESULTS: Strength asymmetry displayed significant difference (p=0.007), mobility, proprioception and mFMS did not (p=0.263, p=0.792 and p=0.181, respectively). Mean scores for mobility, proprioception, strength asymmetry and mFMS for injured versus non-injured players (effect size) were: 40.00 vs 38.00 (0.37), 10.33 vs 10.20 (0.10), 61.13 vs 30.40 (0.80) and 7.33 vs 8.90 (-0.4), respectively. CONCLUSIONS: This study found no relationship between mobility/proprioception and injury risk; however, strength asymmetry was statistically significant in predicting injury and mFMS exhibited enough positive difference for recommendation of further investigation.

The TURis System for Transurethral Resection of the Prostate: A NICE Medical Technology Guidance.

The transurethral resection in saline (TURis) system was notified by the company Olympus Medical to the National Institute of Health and Care Excellence's (NICE's) Medical Technologies Evaluation Programme. Following selection for medical technologies guidance, the company developed a submission of clinical and economic evidence for evaluation. TURis is a bipolar surgical system for treating men with lower urinary tract symptoms due to benign prostatic enlargement. The comparator is any monopolar transurethral resection of the prostate (mTURP) system. Cedar, a collaboration between Cardiff and Vale University Health Board, Cardiff University and Swansea University in the UK, acted as an External Assessment Centre (EAC) for NICE to independently critique the company's submission of evidence. Eight randomised trials provided evidence for TURis, demonstrating efficacy equivalent to that of mTURP for improvement of symptoms. The company presented meta-analyses of key outcome measures, and the EAC made methodological modifications in response to the heterogeneity of the trial data. The EAC analysis found that TURis substantially reduced the relative risks of transurethral resection syndrome (relative risk 0.18 [95 % confidence interval 0.05-0.62]) and blood transfusion (relative risk 0.35 [95 % confidence interval 0.19-0.65]). The company provided a de novo economic model comparing TURis with mTURP. The EAC critiqued the model methodology and made modifications. This found TURis to be cost saving at £70.55 per case for existing Olympus customers and cost incurring at £19.80 per case for non-Olympus customers. When an additional scenario based on the only available data on readmission (due to any cause) from a single trial was modelled, the estimated cost saving per case was £375.02 for existing users of Olympus electrosurgery equipment and £284.66 per case when new Olympus equipment would need to be purchased. Meta-analysis of eight randomised trials showed that TURis is associated with a statistically significantly reduced risk of transurethral resection syndrome and a reduced need for blood transfusion-two factors that may drive cost saving for the National Health Service. The clinical data are equivocal as to whether TURis shortens the hospital stay. Limited data from a single study suggest that TURis may reduce the rate of readmission after surgery. The NICE guidance supports adoption of the TURis technology for performing transurethral resection of the prostate in men with lower urinary tract symptoms due to benign prostatic enlargement.