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This study is supported by the J P Moulton Charitable Foundation (grant number: N/A). The DCD allograft is provided free of charge by NHSBT., The authors wish to thank the principal investigators, research nurses and their teams at the recruiting sites. The authors also wish to thank the NHS Blood and Transplant (NHSBT) for providing the DCD allograft free of charge and for their support in training clinical staff, and the NIHR Clinical Research Networks (CRNs) for their support in identifying sites. Finally, the authors wish to thank all individuals who participated in the PPI focus groups and extend a special thank you to PPI representative Emanuel Ezeife, whose useful feedback helped to inform the design of the study., Introduction Venous leg ulceration (VLU), the most common type of chronic ulcer, can be difficult to heal and is a major cause of morbidity and reduced quality of life. Although compression bandaging is the principal treatment, it is time-consuming and bandage application requires specific training. There is evidence that intervention on superficial venous incompetence can help ulcer healing and recurrence, but this is not accessible to all patients. Hence, new treatments are required to address these chronic wounds. One possible adjuvant treatment for VLU is human decellularised dermis (DCD), a type of skin graft derived from skin from deceased tissue donors. Although DCD has the potential to promote ulcer healing, there is a paucity of data for its use in patients with VLU. Methods and analysis This is a multicentre, parallel group, pragmatic randomised controlled trial. One hundred and ninety-six patients with VLU will be randomly assigned to receive either the DCD allograft in addition to standard care or standard care alone. The primary outcome is the proportion of participants with a healed index ulcer at 12 weeks post-randomisation in each treatment arm. Secondary outcomes include the time to index ulcer healing and the proportion of participants with a healed index ulcer at 12 months. Changes in quality of life scores and cost-effectiveness will also be assessed. All analyses will be carried out on an intention-to-treat (ITT) basis. A mixed-effects, logistic regression on the outcome of the proportion of those with the index ulcer healed at 12 weeks will be performed. Secondary outcomes will be assessed using various statistical models appropriate to the distribution and nature of these outcomes. Ethics and dissemination Ethical approval was granted by the Bloomsbury Research Ethics Committee (19/LO/1271). Findings will be published in a peer-reviewed journal and presented at national and international conferences., J P Moulton Charitable Foundation

Background Treatment of superficial venous reflux in addition to compression therapy accelerates venous leg ulcer healing and reduces ulcer recurrence. The aim of this study was to evaluate the costs and cost-effectiveness of early versus delayed endovenous treatment of patients with venous leg ulcers. Methods This was a within-trial cost-utility analysis with a 1-year time horizon using data from the EVRA (Early Venous Reflux Ablation) trial. The study compared early versus deferred endovenous ablation for superficial venous truncal reflux in patients with a venous leg ulcer. The outcome measure was the cost per quality-adjusted life-year (QALY) over 1 year. Sensitivity analyses were conducted with alternative methods of handling missing data, alternative preference weights for health-related quality of life, and per protocol. Results After early intervention, the mean(s.e.m.) cost was higher (difference in cost per patient £163(318) (€184(358))) and early intervention was associated with more QALYs at 1 year (mean(s.e.m.) difference 0·041(0·017)). The incremental cost-effectiveness ratio (ICER) was £3976 (€4482) per QALY. There was an 89 per cent probability that early venous intervention is cost-effective at a threshold of £20 000 (€22 546)/QALY. Sensitivity analyses produced similar results, confirming that early treatment of superficial reflux is highly likely to be cost-effective. Conclusion Early treatment of superficial reflux is highly likely to be cost-effective in patients with venous leg ulcers over 1 year. Registration number: ISRCTN02335796 (http://www.isrctn.com).

This randomized clinical trial uses data from the Early Venous Reflux Ablation trial to evaluate the long-term clinical and cost benefits of combined early endovenous ablation and compression compared with compression therapy alone and deferred ablation for treating superficial venous reflux of the leg., Key Points Question In patients with venous leg ulceration and superficial reflux, what is the clinical and cost-effectiveness of early endovenous ablation of reflux? Findings In this 450-patient, multicenter, randomized clinical trial, early endovenous ablation with compression accelerated venous ulcer healing, reduced the overall incidence of ulcer recurrence, and was highly cost-effective compared with compression with deferred intervention. Meaning To deliver clinical and cost benefits, leg ulcer care pathways should be revised to include early assessment and treatment of superficial venous reflux., Importance One-year outcomes from the Early Venous Reflux Ablation (EVRA) randomized trial showed accelerated venous leg ulcer healing and greater ulcer-free time for participants who are treated with early endovenous ablation of lower extremity superficial reflux. Objective To evaluate the clinical and cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with venous leg ulceration. Design, Setting, and Participants Between October 24, 2013, and September 27, 2016, the EVRA randomized clinical trial enrolled 450 participants (450 legs) with venous leg ulceration of less than 6 months’ duration and superficial venous reflux. Initially, 6555 patients were assessed for eligibility, and 6105 were excluded for reasons including ulcer duration greater than 6 months, healed ulcer by the time of randomization, deep venous occlusive disease, and insufficient superficial venous reflux to warrant ablation therapy, among others. A total of 426 of 450 participants (94.7%) from the vascular surgery departments of 20 hospitals in the United Kingdom were included in the analysis for ulcer recurrence. Surgeons, participants, and follow-up assessors were not blinded to the treatment group. Data were analyzed from August 11 to November 4, 2019. Interventions Patients were randomly assigned to receive compression therapy with early endovenous ablation within 2 weeks of randomization (early intervention, n = 224) or compression with deferred endovenous treatment of superficial venous reflux (deferred intervention, n = 226). Endovenous modality and strategy were left to the preference of the treating clinical team. Main Outcomes and Measures The primary outcome for the extended phase was time to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and cost-effectiveness. Results The early-intervention group consisted of 224 participants (mean [SD] age, 67.0 [15.5] years; 127 men [56.7%]; 206 White participants [92%]). The deferred-intervention group consisted of 226 participants (mean [SD] age, 68.9 [14.0] years; 120 men [53.1%]; 208 White participants [92%]). Of the 426 participants whose leg ulcer had healed, 121 (28.4%) experienced at least 1 recurrence during follow-up. There was no clear difference in time to first ulcer recurrence between the 2 groups (hazard ratio, 0.82; 95% CI, 0.57-1.17; P = .28). Ulcers recurred at a lower rate of 0.11 per person-year in the early-intervention group compared with 0.16 per person-year in the deferred-intervention group (incidence rate ratio, 0.658; 95% CI, 0.480-0.898; P = .003). Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio, 1.36; 95% CI, 1.12-1.64; P = .002). At 3 years, early intervention was 91.6% likely to be cost-effective at a willingness to pay of £20 000 ($26 283) per quality-adjusted life year and 90.8% likely at a threshold of £35 000 ($45 995) per quality-adjusted life year. Conclusions and Relevance Early endovenous ablation of superficial venous reflux was highly likely to be cost-effective over a 3-year horizon compared with deferred intervention. Early intervention accelerated the healing of venous leg ulcers and reduced the overall incidence of ulcer recurrence. Trial Registration ClinicalTrials.gov identifier: ISRCTN02335796

Background Venous ulceration is a common and costly health-care issue worldwide, with poor healing rates greatly affecting patient quality of life. Compression bandaging has been shown to improve healing rates and reduce recurrence, but does not address the underlying cause, which is often superficial venous reflux. Surgical correction of the reflux reduces ulcer recurrence; however, the effect of early endovenous ablation of superficial venous reflux on ulcer healing is unclear. Objectives To determine the clinical effectiveness and cost-effectiveness of compression therapy with early endovenous ablation of superficial venous reflux compared with compression therapy with deferred endovenous ablation in patients with venous ulceration. Design A pragmatic, two-arm, multicentre, parallel-group, open randomised controlled trial with a health economic evaluation. Setting Secondary care vascular centres in England. Participants Patients aged ≥ 18 years with a venous leg ulcer of between 6 weeks’ and 6 months’ duration and an ankle–brachial pressure index of ≥ 0.8 who could tolerate compression and were deemed suitable for endovenous ablation of superficial venous reflux. Interventions Participants were randomised 1 : 1 to either early ablation (compression therapy and superficial endovenous ablation within 2 weeks of randomisation) or deferred ablation (compression therapy followed by endovenous ablation once the ulcer had healed). Main outcome measures The primary outcome measure was time from randomisation to ulcer healing, confirmed by blinded assessment. Secondary outcomes included 24-week ulcer healing rates, ulcer-free time, clinical success (in addition to quality of life), costs and quality-adjusted life-years (QALYs). All analyses were performed on an intention-to-treat basis. Results A total of 450 participants were recruited (224 to early and 226 to deferred superficial endovenous ablation). Baseline characteristics were similar between the two groups. Time to ulcer healing was shorter in participants randomised to early superficial endovenous ablation than in those randomised to deferred ablation [hazard ratio 1.38, 95% confidence interval (CI) 1.13 to 1.68; p = 0.001]. Median time to ulcer healing was 56 (95% CI 49 to 66) days in the early ablation group and 82 (95% CI 69 to 92) days in the deferred ablation group. The ulcer healing rate at 24 weeks was 85.6% in the early ablation group, compared with 76.3% in the deferred ablation group. Median ulcer-free time was 306 [interquartile range (IQR) 240–328] days in the early ablation group and 278 (IQR 175–324) days in the deferred endovenous ablation group (p = 0.002). The most common complications of superficial endovenous ablation were pain and deep-vein thrombosis. Differences in repeated measures of Aberdeen Varicose Vein Questionnaire scores (p p = 0.03) and Short Form questionnaire-36 items body pain (p = 0.05) over the follow-up period were observed, in favour of early ablation. The mean difference in total costs between the early ablation and deferred ablation groups was £163 [standard error (SE) £318; p = 0.607]; however, there was a substantial and statistically significant gain in QALY over 1 year [mean difference between groups 0.041 (SE 0.017) QALYs; p = 0.017]. The incremental cost-effectiveness ratio of early ablation at 1 year was £3976 per QALY, with a high probability (89%) of being more cost-effective than deferred ablation at conventional UK decision-making thresholds (currently £20,000 per QALY). Sensitivity analyses using alternative statistical models give qualitatively similar results. Limitations Only 7% of screened patients were recruited, treatment regimens varied significantly and technical success was assessed only in the early ablation group. Conclusions Early endovenous ablation of superficial venous reflux, in addition to compression therapy and wound dressings, reduces the time to healing of venous leg ulcers, increases ulcer-free time and is highly likely to be cost-effective. Future work Longer-term follow-up is ongoing and will determine if early ablation will affect recurrence rates in the medium and long term. Trial registration Current Controlled Trials ISRCTN02335796. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 24. See the NIHR Journals Library website for further project information.

Objective: To assess the outcome after transthoracic endoscopic sympathectomy (TES) for upper limb hyperhidrosis. Design: Prospective cohort study. Setting: District general hospital. Subjects: Consecutive patients undergoing TES for upper limb hyperhidrosis over a fifteen month period. Interventions: One-stage bilateral TES. Main outcome measures: Change in quality of life as shown by the Short Form-36 health assessment questionnaire. Results: Sixteen patients (11 women and 5 men, median age 26 years) underwent operation without complications. At median follow-up of 6.2 months, symptomatic improvement was found in 26 of 32 limbs treated (82%). Truncal compensatory hyperhidrosis was reported by 13 patients but was severe in only three. There were significant improvements in social function (p = 0.01) and mental health (p = 0.025) as assessed by the SF-36. Conclusion: Despite a high incidence of compensatory hyperhidrosis, TES improved both the symptoms and overall quality of life in patients with upper limb hyperhidrosis. Copyright © 1998 Taylor and Francis Ltd.

Much has been written on the subject of graft surveillance following infra-inguinal bypass graft surgery, but surprisingly little information exists on actual attendance rates for such programmes. The aim of this study was to calculate the attendance rate for graft surveillance at the vascular unit in Cheltenham. All patients who entered the graft surveillance programme following an infra-inguinal graft procedure over a 5-year period were included in the study. Partial and complete surveillance attendance rates were calculated for each year in the study period. Both rates were seen to rise over the 5-year period, from 31% to 78% and 0 to 38%, respectively. These attendance rates were much lower than were expected. Vascular units relying on such graft surveillance programmes should evaluate their own 'surveillance rates'.

Acute leg ischaemia is both life threatening and limb threatening. This audit was designed to determine the incidence and outcome of acute leg ischaemia in a single county.Using multisource data collection for a 1-year interval in 1994 all patients with acute leg ischaemia were identified prospectively using hospital and general practice records in the county of Gloucestershire, population 540,000.Seventy-seven patients with 84 events of acute leg ischaemia were identified, giving an incidence of one per 7000 per year rising to one per 6000 per year when bypass graft occlusions were included. All but four patients were treated in hospital. Sixteen of 80 hospital events involved conservative treatment; after 30 days nine patients had died and two required amputation. The remaining five patients had borderline ischaemic rest pain and accepted their symptoms without intervention. Sixty-four of 80 events were managed by either primary surgery and angioplasty (n = 31) or thrombolysis (n = 33). The 30-day outcome in patients treated actively was: limb salvage in 50 (78 per cent), amputation in four (6 per cent) and death in ten (16 per cent).In Gloucestershire almost all cases of acute leg ischaemia are managed by, or discussed with vascular surgeons. A flexible integrated policy of surgery and peripheral thrombolysis has resulted in a limb salvage rate of 78 per cent in patients suitable for active treatment.

To report the results of a protocol for the preoperative diagnosis of stones in the common bile duct in patients with symptomatic cholelithiasis.Prospective open study.District general hospital, United Kingdom.Ultrasonography and liver function tests, and in selected patients preoperative cholangiography.The ability of the investigations to diagnose stones in the common bile duct preoperatively.Ultrasonography or liver function tests, or both indicated that 53 patients were at low risk of having stones in the common duct, and they underwent laparoscopic cholecystectomy without further investigation. A further 38 patients had minor abnormalities on the first two investigations and underwent intravenous cholangiography; ductal stones were identified in 6. Nine patients were thought to be at high risk and so underwent endoscopic retrograde cholangiopancreatography (ERCP) or open exploration of the common bile duct, and stones were found in 5. No further stones have been identified after a minimum follow up of 12 months.Selective preoperative cholangiography is a reliable way of detecting stones in the common bile duct before laparoscopic cholecystectomy.

Transthoracic endoscopic sympathectomy is now considered the treatment of choice for patients with upper limb hyperhidrosis requiring sympathetic ablation. This procedure requires the use of an endobronchial double lumen tube and subsequent one-lung anaesthesia, a technique that is associated with a number of potential problems. Full patient monitoring is thus required and includes pulse, ECG, non-invasive blood pressure measurement, pulse oximetry, end-tidal carbon dioxide concentration and peak inspiratory airway pressure. We reviewed our anaesthetic technique and peri-operative complications in 26 patients, to assess patient safety. In our study hypoxaemia occurred commonly but was transient in all bar one case where re-expansion of the lung was required. Hypotension occurred at two stages of the procedure, but active intervention was not required, and two patients required underwater drainage of the pleural cavity for treatment of pneumothorax. With skilled anaesthetic personnel and adequate monitoring this procedure may be carried out safely.

The pathophysiological response to peripheral percutaneous transluminal balloon angioplasty in 20 patients was investigated using 111-Indium labelled platelets. Platelet deposition was quantified by measuring the degree of radioactivity uptake at angioplasty and control sites using a computer linked system and expressing the uptake as a ratio of angioplasty/control. Following platelet labelling, scans were performed before angioplasty and at 1, 24 and 48 h after angioplasty. To assess patency of the angioplasty, ankle brachial Doppler pressure indices were performed and supported by repeat angiograms if doubt of patency existed. All patients were followed-up at 1 week, 1 month and 6 months to correlate the degree of early platelet uptake with failure. The mean +/- sem platelet radioactivity ratio at the angioplasty site increased from 1.1 +/- 0.1 prior to the procedure to a peak of 2.1 +/- 0.3 at 1 h (p less than 0.01), 1.6 +/- 0.2 at 24 h (p less than 0.05), and 1.7 +/- 0.3 at 48 h (p less than 0.05). Angioplasties that failed within 6 months tended to have a higher maximum early platelet uptake (3.1 +/- 0.6) compared to successful angioplasties (1.9 +/- 0.3) but the difference was not significant in the numbers studied. This study provides a suitable model to assess the role of platelet accumulation in angioplasty failure and the influence of various antiplatelet regimes.

The aetiology and treatment of 35 femoral false anastomotic aneurysms in 29 patients presenting over the 4-year period 1984–88 were reviewed retrospectively. The mean interval between primary anastomosis and false aneurysm repair was 6 years (range from 2 weeks to 16 years). Twenty-two (63 per cent) false aneurysms had occurred after previous aortobifemoral bypass grafting for occlusive aortoiliac disease. Seven (20 per cent) presented as acute surgical emergencies. Review of the records of the initial operations revealed that superficial wound infections with positive bacteriological cultures had been present in eight cases (23 per cent) and a further two (6 per cent) had lymph fistulae. Thirty-two false aneurysms were repaired, by simple reanastomosis in 14 cases, interposition grafting in 17 cases and in one case by complete revision to an aortobifemoral bypass graft. The risk of a further operative repair was less (P < 0.05) following interposition grafting, than after simple revision. False aneurysm repairs, when compared with primary reconstructions done during the same period, were associated with more superficial wound infections (37 versus 10 per cent) and more explorations for haemorrhage within 30 days (19 versus 7 per cent).

Chronic venous ulcers are common, and even with effective compression or elevation large ulcers may take months to heal. Pinch skin grafting may allow healing from epithelial islands throughout the surface area of the ulcer, and a prospective randomised trial was therefore conducted comparing this treatment with porcine dermis dressings. Most patients were treated as outpatients, 25 ulcers being randomised to treatment with pinch skin grafts and 28 to treatment with porcine dermis. Though the groups were well matched, the mean healing rate in the first week was 15 cm2 for pinch skin grafts compared with 3.5 cm2 with porcine dermis (p less than 0.02). By life table analysis 64% of ulcers treated by pinch grafts were healed at six weeks and 74% by 12 weeks compared with 29% and 46% of ulcers, respectively, treated with porcine dermis dressings (chi2 = 4.1; p less than 0.05). All ulcers that failed to heal within 12 weeks included an area posterior to the medial malleolus, where local compression may have been inadequate. Pinch skin grafting improves the rate of healing in large venous ulcers and is a simple technique that may be performed as an outpatient procedure under local anaesthesia.

Between January 1980 and September 1988, 34 octogenarians underwent aortic aneurysm repair. There were 26 men and eight women with a median age of 83 years (range 80–88 years). Twenty underwent ‘emergency’ repair after presenting with pain and/or collapse: 11 with a retroperitoneal rupture, three with an intraperitoneal rupture and six with an expanding aneurysm. The mortality rate for this group was 35 per cent. During the same period 14 patients had an elective repair and there were no deaths within 30 days. The mean hospital stay for the elective group was 14.2 days compared with 17.0 days for survivors in the emergency group. There was no significant difference in terms of risk factors between those who developed postoperative complications and those who did not. These mortality rates compare favourably with our overall mortality results for elective (4.6 per cent) and emergency (31 per cent) surgery. Those patients over 80 years of age with infrarenal abdominal aortic aneurysms should not be refused surgery on the basis of age alone; each patient should be judged individually.

Multiple pulmonary emboli are recognized to be the cause of progressive pulmonary failure. In these patients, the source of emboli may be difficult to detect, even by venography. The authors describe the use of autologous Indium 111-labeled platelets to locate the origin in a patient with progressing right heart failure.

Two cases of claudication of the cauda equina due to ischaemia secondary to distal aortic disease in the Small Aorta syndrome are reported. The association has not been previously reported and the appropriate management is discussed.

Summary A case of pneumatosis cystoides intestinalis discovered at laparotomy for a perforated duodenal ulcer is described. Nitrous oxide administration is contra-indicated in this condition, and the rapid effectiveness of 100% oxygen administration is observed during the surgical procedure.

Conservative measures to improve claudication distance include advice on smoking, exercise, diet and weight reduction. Although the effects of smoking, exercise and diet are established, the effect of weight is less clear. The aim of this study was to investigate the effect of carrying extra weight on the maximum walking distance in stable claudicants. Twenty stable claudicants were exercised on a treadmill (3.5 km/h, 0º slope) carrying 0, 2.5, 5, 7.5 and 10 kg weights in randomized sequence. Maximum claudication distance and ankle: brachial pressure indices were recorded. Patients were categorized into mild or severe claudicants depending on their ability to walk 200 m. A response index (RI) was calculated as the reduction in claudication distance per kilogram load; RI = [CD0 − CD10]/10 m/kg, where CD0 and CD10 represent claudication distance with 0 and 10 kg weights, respectively. Claudication distance was significantly reduced in subjects carrying 5 kg or more (P < 0.01). A linear relationship was demonstrated between the mean claudication distance and the load carried (r = 0.98, P < 0.01) with a mean response index of 10.2 m/kg. The mean(s.e.m.) RI in mild claudicants (25.9(9.5) m/kg) was greater than the value observed in the severe claudicants (3.3(0.8) m/kg; P < 0.01, Mann-Whitney U test). This study demonstrates that weight adversely affects claudication distance and suggests that weight reduction may deserve greater emphasis in the management of some patients with intermittent claudication.