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Background: Chronic limb-threatening ischaemia (CLTI) is a condition associated with significant risks of lower limb loss and mortality, which increase with delays in management. Guidance recommends urgent referral and assessment, but delays are evident at every stage of the CLTI patient pathway. This study uses qualitative methods to explore hospital clinicians' experiences and perceptions of the existing CLTI pathway., Methods: A qualitative interview study was conducted. Semi-structured interviews were undertaken with 13 clinicians involved in the assessment of patients referred to hospital with suspected CLTI, identified via purposive sampling from English vascular surgery units. Clinicians included podiatrists, vascular specialist nurses and doctors. Reflexive thematic analysis was performed on the data from a critical realist position., Results: The need for speed was the single overarching theme identified. Four linked underlying themes were also identified; 1. Vascular surgery as the poor relation (compared to cancer and other specialties), with a sub-theme of CLTI being a challenging diagnosis. 2. Some patients are more equal than others, with sub-themes of diabetes vs. non-diabetes, hub vs. spoke and frailty vs. non-frail. 3. Life in the National Health Service (NHS) is tough, with sub-themes of lack of resource and we're all under pressure. 4. Non-surgeons can help., Conclusions: The underlying themes generated from the rich interview data describe barriers to timely referral, assessment and management of CLTI, as well as the utility of non-surgical roles such as podiatrists and vascular specialist nurses as a potential solution for delays. The overarching theme of the need for speed highlights the meaning given to adverse consequences of delays in management of CLTI by clinicians involved in its assessment. Future improvement projects aimed at the CLTI pathway should take these findings into account., (© 2023. The College of Podiatry and the Australasian Podiatry Council.)

Background: Venous leg ulcers (VLUs) are a serious manifestation of chronic venous disease affecting up to 3% of the adult population. This typically recalcitrant and recurring condition significantly impairs quality of life, and its treatment places a heavy financial burden upon healthcare systems. The longstanding mainstay treatment for VLUs is compression therapy. Surgical removal of incompetent veins reduces the risk of ulcer recurrence. However, open surgery is an unpopular option amongst people with VLU, and many people are unsuitable for it. The efficacy of the newer, minimally-invasive endovenous techniques has been established in uncomplicated superficial venous disease, and these techniques can also be used in the management of VLU. When used with compression, endovenous ablation aims to further reduce pressure in the veins of the leg, which may impact ulcer healing., Objectives: To determine the effects of superficial endovenous ablation on the healing and recurrence of venous leg ulcers and the quality of life of people with venous ulcer disease., Search Methods: In April 2022 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scrutinised reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions on the language of publication, but there was a restriction on publication year from 1998 to April 2022 as superficial endovenous ablation is a comparatively new technology., Selection Criteria: Randomised controlled trials (RCTs) comparing endovenous ablative techniques with compression versus compression therapy alone for the treatment of VLU were eligible for inclusion. Studies needed to have assessed at least one of the following primary review outcomes related to objective measures of ulcer healing such as: proportion of ulcers healed at a given time point; time to complete healing; change in ulcer size; proportion of ulcers recurring over a given time period or at a specific point; or ulcer-free days. Secondary outcomes of interest were patient-reported quality of life, economic data and adverse events., Data Collection and Analysis: Two reviewers independently assessed studies for eligibility, extracted data, carried out risk of bias assessment using the Cochrane RoB 1 tool, and assessed GRADE certainty of evidence., Main Results: The previous version of this review found no RCTs meeting the inclusion criteria. In this update, we identified two eligible RCTs and included them in a meta-analysis. There was a total of 506 participants with an active VLU, with mean durations of 3.1 months ± 1.1 months in the EVRA trial and 60.5 months ± 96.4 months in the VUERT trial. Both trials randomised participants to endovenous treatment and compression or compression alone, however the compression alone group in the EVRA trial received deferred endovenous treatment (after ulcer healing or from six months). There is high-certainty evidence that combined endovenous ablation and compression compared with compression therapy alone, or compression with deferred endovenous treatment, improves time to complete ulcer healing (pooled hazard ratio (HR) 1.41, 95% CI 1.36 to 1.47; I 2 = 0%; 2 studies, 466 participants). There is moderate-certainty evidence that the proportion of ulcers healed at 90 days is probably higher with combined endovenous ablation and compression compared with compression therapy alone or compression with deferred endovenous treatment (risk ratio (RR) 1.14, 95% CI 1.00 to 1.30; I 2 = 0%; 2 studies, 466 participants). There is low-certainty evidence showing an unclear effect on ulcer recurrence at one year in people with healed ulcers with combined endovenous treatment and compression when compared with compression alone or compression with deferred endovenous treatment (RR 0.29, 95% CI 0.03 to 2.48; I 2 = 78%; 2 studies, 460 participants). There is also low-certainty evidence that the median number of ulcer-free days at one year may not differ (306 (interquartile range (IQR) 240 to 328) days versus 278 (IQR 175 to 324) days) following combined endovenous treatment and compression when compared with compression and deferred endovenous treatment; (1 study, 450 participants). There is low-certainty evidence of an unclear effect in rates of thromboembolism between groups (RR 2.02, 95% CI 0.51 to 7.97; I 2 = 78%, 2 studies, 506 participants). The addition of endovenous ablation to compression is probably cost-effective at one year (99% probability at GBP 20,000/QALY; 1 study; moderate-certainty evidence)., Authors' Conclusions: Endovenous ablation of superficial venous incompetence in combination with compression improves leg ulcer healing when compared with compression alone. This conclusion is based on high-certainty evidence. There is moderate-certainty evidence to suggest that it is probably cost-effective at one year and low certainty evidence of unclear effects on recurrence and complications. Further research is needed to explore the additional benefit of endovenous ablation in ulcers of greater than six months duration and the optimal modality of endovenous ablation., (Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Background: Patients with diabetes and peripheral arterial disease are at increased risk of minor amputation. The aim of study was to assess the rate of re-amputations and death after an initial minor amputation, and to identify associated risk factors., Methods: Data on all patients aged 40 years and over with diabetes and/or peripheral arterial disease, who underwent minor amputation between January 2014 and December 2018, were extracted from Hospital Episode Statistics. Patients who had bilateral index procedures or an amputation in the 3 years before the study were excluded. Primary outcomes were ipsilateral major amputation and death after the index minor amputation. Secondary outcomes were ipsilateral minor re-amputations, and contralateral minor and major amputations., Results: In this study of 22 118 patients, 16 808 (76.0 per cent) were men and 18 473 (83.5 per cent) had diabetes. At 1 year after minor amputation, the estimated ipsilateral major amputation rate was 10.7 (95 per cent c.i. 10.3 to 11.1) per cent. Factors associated with a higher risk of ipsilateral major amputation included male sex, severe frailty, diagnosis of gangrene, emergency admission, foot amputation (compared with toe amputation), and previous or concurrent revascularization. The estimated mortality rate was 17.2 (16.7 to 17.7) per cent at 1 year and 49.4 (48.6 to 50.1) per cent at 5 years after minor amputation. Older age, severe frailty, comorbidity, gangrene, and emergency admission were associated with a significantly higher mortality risk., Conclusion: Minor amputations were associated with a high risk of major amputation and death. One in 10 patients had an ipsilateral major amputation within the first year after minor amputation and half had died by 5 years., (© The Author(s) 2023. Published by Oxford University Press on behalf of BJS Society Ltd.)

Background: The European Association of Endoscopic Surgery (EAES) is a surgical society who promotes the development and expansion of minimally invasive surgery to surgeons and surgical trainees. It does so through its activities in education, training, and research. The EAES research committee aims to promote the highest quality clinical research in endoscopic and minimally invasive surgery. They have provided grant funding since 2009 in education, surgery, and basic science. Despite the success and longevity of the scheme, the academic and non-academic impact of the research funding scheme has not been evaluated., Aims: The primary aim of this project is to assess the short, long term academic and real world impact of the EAES funding scheme. The secondary aims are to identify barriers and facilitators for achieving good impact., Methods: This will be a mixed qualitative and quantitative study. Semi-structured interviews will be performed with previous grant recipients. The questions for the interviews will be selected after a consensus is achieved amongst the members of the steering committee of this project. The responses will be transcribed and thematic analysis will be applied. The results of the thematic analysis will be used to populate a questionnaire which will be disseminated to grant recipients. This study is kindly funded by the EAES., Discussion: The first question this project is expected to answer is whether the EAES research funding scheme had a significant positive impact on research output, career progression but also non-academic output such as change in clinical guidelines, healthcare quality and cost-effectiveness improvement. This project however is also expected to identify facilitators and barriers to successful completion of projects and to achieving high impact. This will inform EAES and the rest of the surgical and academic communities as to how clinicians would like to be supported when conducting research. There should also be a positive and decisive change towards removing factors that hinder the timely and successful completion of projects., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 McClean, Huo, Kwan, Long, Walshaw, Mesri, Francis, Arulampalam, Chetter and Yiasemidou.)

Background: Chronic limb-threatening ischaemia is the severest manifestation of peripheral arterial disease and presents with ischaemic pain at rest or tissue loss (ulceration, gangrene, or both), or both. We compared the effectiveness of a vein bypass first with a best endovascular treatment first revascularisation strategy in terms of preventing major amputation and death in patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion., Methods: Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-2 was an open-label, pragmatic, multicentre, phase 3, randomised trial done at 41 vascular surgery units in the UK (n=39), Sweden (n=1), and Denmark (n=1). Eligible patients were those who presented to hospital-based vascular surgery units with chronic limb-threatening ischaemia due to atherosclerotic disease and who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion. Participants were randomly assigned (1:1) to receive either vein bypass (vein bypass group) or best endovascular treatment (best endovascular treatment group) as their first revascularisation procedure through a secure online randomisation system. Participants were excluded if they had ischaemic pain or tissue loss considered not to be primarily due to atherosclerotic peripheral artery disease. Most vein bypasses used the great saphenous vein and originated from the common or superficial femoral arteries. Most endovascular interventions comprised plain balloon angioplasty with selective use of plain or drug eluting stents. Participants were followed up for a minimum of 2 years. Data were collected locally at participating centres. In England, Wales, and Sweden, centralised databases were used to collect information on amputations and deaths. Data were analysed centrally at the Birmingham Clinical Trials Unit. The primary outcome was amputation-free survival defined as time to first major (above the ankle) amputation or death from any cause measured in the intention-to-treat population. Safety was assessed by monitoring serious adverse events up to 30-days after first revascularisation. The trial is registered with the ISRCTN registry, ISRCTN27728689., Findings: Between July 22, 2014, and Nov 30, 2020, 345 participants (65 [19%] women and 280 [81%] men; median age 72·5 years [62·7-79·3]) with chronic limb-threatening ischaemia were enrolled in the trial and randomly assigned: 172 (50%) to the vein bypass group and 173 (50%) to the best endovascular treatment group. Major amputation or death occurred in 108 (63%) of 172 patients in the vein bypass group and 92 (53%) of 173 patients in the best endovascular treatment group (adjusted hazard ratio [HR] 1·35 [95% CI 1·02-1·80]; p=0·037). 91 (53%) of 172 patients in the vein bypass group and 77 (45%) of 173 patients in the best endovascular treatment group died (adjusted HR 1·37 [95% CI 1·00-1·87]). In both groups the most common causes of morbidity and death, including that occurring within 30 days of their first revascularisation, were cardiovascular (61 deaths in the vein bypass group and 49 in the best endovascular treatment group) and respiratory events (25 deaths in the vein bypass group and 23 in the best endovascular treatment group; number of cardiovascular and respiratory deaths were not mutually exclusive)., Interpretation: In the BASIL-2 trial, a best endovascular treatment first revascularisation strategy was associated with a better amputation-free survival, which was largely driven by fewer deaths in the best endovascular treatment group. These data suggest that more patients with chronic limb-threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion should be considered for a best endovascular treatment first revascularisation strategy., Funding: UK National Institute of Health Research Health Technology Programme., Competing Interests: Declaration of interests AWB reports salary part paid by a National Institute for Health (NIHR) and Care Research Health Technology Assessment (HTA) BASIL-2 grant; payment expert advice and testimony from NHS Resolution, His Majesty's Coroners, National Crime Agency, UK, Scotland, Wales, and Northern Ireland Governments, and various law firms, outside of the submitted work; and payment to his institution and personal honoraria for committee work from NIHR HTA and NICE. GRB reports salary part paid by a NIHR HTA BASIL-2 grant; the BASIL-2 grant also paid mileage for visiting patients in the BASIL-2 trial for follow-up assessments. AD reports honoraria from Boston Scientific, Cordis, Medalliance, and Abbott. KH reports honoraria from Le Maitre and Bayer. STR reports payment for expert testimony from McCollum Consultants; consulting fees from 3M, Bayer, and Avita; speaker fees from 3M, Bayer, Avita, and Terumo; travel support Bayer and Terumo; and is an advisory board member for 3M, Bayer, and Avita. AS reports honoraria and institutional grant support from Shockwave and Abbott and unpaid committee work for NICE. HZ reports an institutional grant from Abbott and honoraria from Limflow, Abbott, Boston Scientific, Bentley, Cook Medical, and Medtronic. All other authors declare no competing interests., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Minimally invasive (MI) surgery has revolutionised surgery, becoming the standard of care in many countries around the globe. Observed benefits over traditional open surgery include reduced pain, shorter hospital stay, and decreased recovery time. Gastrointestinal surgery in particular was an early adaptor to both laparoscopic and robotic surgery. Within this review, we provide a comprehensive overview of the evolution of minimally invasive gastrointestinal surgery and a critical outlook on the evidence surrounding its effectiveness and safety., Methods: A literature review was conducted to identify relevant articles for the topic of this review. The literature search was performed using Medical Subject Heading terms on PubMed. The methodology for evidence synthesis was in line with the four steps for narrative reviews outlined in current literature. The key words used were minimally invasive, robotic, laparoscopic colorectal, colon, rectal surgery., Conclusion: The introduction of minimally surgery has revolutionised patient care. Despite the evidence supporting this technique in gastrointestinal surgery, several controversies remain. Here we discuss some of them; the lack of high level evidence regarding the oncological outcomes of TaTME and lack of supporting evidence for robotic colorectalrectal surgery and upper GI surgery. These controversies open pathways for future research opportunities with RCTs focusing on comparing robotic to laparoscopic with different primary outcomes including ergonomics and surgeon comfort., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Walshaw, Huo, McClean, Gajos, Kwan, Tomlinson, Biyani, Dimashki, Chetter and Yiasemidou.)

Objective: There is limited information on changes in the patterns of care and outcomes for patients who had vascular procedures after the first wave of the COVID-19 pandemic. The aim of this population based study was to examine the patterns of care and outcomes for vascular lower limb procedures in the UK during the COVID-19 pandemic., Methods: Lower limb revascularisations and major amputations performed from January 2019 to April 2021 in the UK and entered in the National Vascular Registry were included in the study. The primary outcome was in hospital post-operative death and secondary outcomes were complications and re-interventions. The study was divided into Pre-pandemic (1 January 2019 - 29 February 2020), Wave 1 (1 March - 30 June 2020), Respite (1 July - 31 October 2020), Wave 2/3 (1 November 2020 - 30 April 2021)., Results: The study included 36 938 procedures (7 245 major amputations, 16 712 endovascular, 12 981 open revascularisations), with 15 501 procedures after March 2020, a 27.7% reduction compared with pre-pandemic. The proportion of open surgical procedures performed under general anaesthetic was lower in Wave 1 and after compared with pre-pandemic (76.7% vs. 81.9%, p < .001). Only 4.6% of patients in the cohort had SARS-CoV-2 infection (n = 708), but their in hospital post-operative mortality rate was 25.0% (n = 177), six times higher than patients without SARS-CoV-2 (adjusted odds ratio 5.88; 95% CI 4.80 - 7.21, p < .001). The in hospital mortality rate was higher during the pandemic than pre-pandemic after elective open and endovascular revascularisation (respectively 1.6% vs. 1.1%, p = .033, and 0.9% vs. 0.5%, p = .005) and after major amputations (10.4% during Wave 2/3 vs. 7.7% pre-pandemic, p = .022)., Conclusion: There was excess post-operative mortality rate for patients undergoing lower limb vascular procedures during the pandemic, which was associated with SARS-CoV-2 infections. Further research should be conducted on long term outcomes of patients operated on during the COVID-19 pandemic period., (Copyright © 2023 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Background: High-quality surgical care is vital to deliver the excellent outcomes patients deserve following surgical treatment. Quality improvement collaboratives (QICs) are based on a multicentre model for improving healthcare. They are increasingly used but their effectiveness in the context of surgical services is unclear. This review assessed effectiveness of QICs in National Health Service (NHS) surgical settings, and identified factors that influenced implementation., Methods: A systematic search of MEDLINE and EMBASE, as well as grey literature, was conducted in January 2022 to identify evaluations of QICs in NHS surgical settings. Data were extracted on the intervention, setting, study results and factors that were identified as facilitators or barriers. These were coded using the Consolidated Framework for Implementation Research (CFIR). The quality of study reports was assessed using Quality Improvement Minimum Criteria Set., Results: Fifteen reports on 10 QICs met inclusion criteria. The evaluations used study designs of different strength, with one using a stepped-wedge randomised controlled trial (RCT). Eight studies reported the QIC had been successful in achieving their principal aims, which covered a mix of patient outcomes and process indicators. The study based on the RCT found the QIC was not successful (no improvement in patient outcomes). Each article reported a range of facilitators and barriers to effectiveness of implementation of the QIC, which were spread across the CFIR domains (intervention, outer setting, inner setting, individuals and process). There were few barriers reported in the intervention domain that related to the QIC. There was no clear relationship between numbers of facilitators and barriers reported and effectiveness., Conclusions: Studies have reported QICs to be effective in increasingly complex contexts, but their results must be treated with caution. The evaluations often used weak study designs and the quality of reports was variable. Evaluation with strong study design should be integral to future QICs., Prospero Registration Number: CRD42022324970., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Since the COVID-19 pandemic there has been a rapid uptake and utilisation of telemedicine in all aspects of healthcare. This presents a key opportunity in surgical site infection surveillance. Remote follow up methods have been used via telephone, with photographs and questionnaires for post-operative reviews with varying results. This review therefore aims to comprehensively synthesise available evidence for the diagnostic accuracy of all forms of SSI telemedicine monitoring. The protocol has been established as per both PRISMA-P (S1 Table) and the Cochrane handbook for reviews of diagnostic test accuracy. Medline, Embase, CENTRAL and CINAHL will be searched using a complete search strategy developed with librarian input, in addition to google scholar and hand searching. All study designs with patients over 18 and undergone a primarily closed surgical procedure will be eligible. Index tests will include all forms of telemedicine and a subgroup analysis performed for each of these. Comparative tests must include face to face review, and all reference standards will be included again for sub-group analyses. Search results will be screened by two investigators independently with a third providing consensus review on disagreements. Methodological quality will be assessed using the QUADAS-2 tool, first validated by two investigators as per the Cochrane handbook. Exploratory analysis will formulate summary receiver operating characteristic curves and forest plots with estimates of sensitivity and specificity of the included studies. Sources of heterogeneity will be identifying and investigated through further analysis. Potential benefits of telemedicine integration in surgical practice will reduce cost and travel time to patients in addition to avoiding wasted clinic appointments, important considerations in a peri-pandemic era. To avoid missed or further complications, there must be confidence in the ability to diagnose infection. This review will systematically determine whether telemedicine is accurate for surgical site infection diagnosis, which methods are well established and if further research is indicated., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Lathan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Aim: Achieve an international consensus on how to recover lost training opportunities. The results of this study will help inform future EAES guidelines about the recovery of surgical training before and after the pandemic., Background: A global survey conducted by our team demonstrated significant disruption in surgical training during the COVID-19 pandemic. This was wide-spread and affected all healthcare systems (whether insurance based or funded by public funds) in all participating countries. Thematic analysis revealed the factors perceived by trainees as barriers to training and gave birth to four-point framework of recovery. These are recommendations that can be easily achieved in any country, with minimal resources. Their implementation, however, relies heavily on the active participation and leadership by trainers. Based on the results of the global trainee survey, the authors would like to conduct a Delphi-style survey, addressed to trainers on this occasion, to establish a pragmatic step-by-step approach to improve training during and after the pandemic., Methods: This will be a mixed qualitative and quantitative study. Semi-structured interviews will be performed with laparoscopic trainers. These will be transcribed and thematic analysis will be applied. A questionnaire will then be proposed; this will be based on both the results of the semi structured interviews and of the global trainee survey. The questionnaire will then be validated by the steering committee of this group (achieve consensus of >80%). After validation, the questionnaire will be disseminated to trainers across the globe. Participants will be asked to consent to participate in further cycles of the Delphi process until more than 80% agreement is achieved., Results: This study will result in a pragmatic framework for continuation of surgical training during and after the pandemic (with special focus on minimally invasive surgery training)., Competing Interests: The authors have declared that no competing interests exist.

Defunctioning stomas (ileostomy and colostomy) may be used prior to commencement of neoadjuvant therapy in patients with locally advanced colon or rectal cancer, in order to prevent clinical large bowel obstruction caused by radiotherapy associated oedema or progression of disease in patients who are not obstructed. However, the exact rate of clinical obstruction in patients undergoing neoadjuvant therapy who do not receive a defunctioning stoma is not known. Furthermore, it is not clear which factors predispose patients to developing clinical large bowel obstruction. Given that defunctioning stomas are associated with post operative and intra-operative risks, it is not currently possible to tailor defunctioning stomas to patients who have the greatest risk of developing obstruction. This systematic review which is in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement (PRISMA), aims to define the role of defunctioning stomas in prevention of obstruction patients with locally advanced colon or rectal cancer while undergoing neoadjuvant therapy. Two researchers will perform the literature search which will include all published and "in process" articles published in the English language between 2002-2022 in the following databases: EMBASE (OVID), MEDLINE (EBSCO), CINHAL complete, Web of Science, Cochrane Central Registry of Controlled Trials, Clinical Trials Registry. The full text of the selected articles will be independently screened by two researchers against the inclusion criteria. Data will be extracted from each article regarding: study design, participants, type of intervention and outcomes. The effect size will be expressed in incidence rates and when appropriate in relative risk with 95% confidence intervals. If possible, we will perform a meta-analysis. Heterogeneity will be assessed using I2 statistics. We will pool the data extracted from the randomised controlled trials to perform a meta-analysis using the Review Manager 5 software (RevMan 5). The Grades of Recommendation, Assessment, Development and Evaluation (GRADE) system will be used to assess the certainty of the evidence., Competing Interests: The authors have declared that no competing interests exist.

The Sars-CoV-2 pandemic catalysed integration of telemedicine worldwide. This systematic review assesses it's accuracy for diagnosis of Surgical Site Infection (SSI). Databases were searched for telemedicine and wound infection studies. All types of studies were included, only paired designs were taken to meta-analysis. QUADAS-2 assessed methodological quality. 1400 titles and abstracts were screened, 61 full text reports were assessed for eligibility and 17 studies were included in meta-analysis, mean age was 47.1 ± 13.3 years. Summary sensitivity and specificity was 87.8% (95% CI, 68.4-96.1) and 96.8% (95% CI 93.5-98.4) respectively. The overall SSI rate was 5.6%. Photograph methods had lower sensitivity and specificity at 63.9% (95% CI 30.4-87.8) and 92.6% (95% CI, 89.9-94.5). Telemedicine is highly specific for SSI diagnosis is highly specific, giving rise to great potential for utilisation excluding SSI. Further work is needed to investigate feasibility telemedicine in the elderly population group., (© 2022. The Author(s).)

Background: International guidelines recommend postprocedural compression when treating symptomatic superficial venous incompetence (SVI). This updated review of RCTs investigated the requirement for postprocedural compression and how it can be applied optimally., Methods: The National Institute for Health and Care Excellence's Healthcare Databases Advanced Search engine was used to identify all English-language RCTs of compression following treatment for SVI. Outcomes of interest included postprocedural pain, venous thromboembolism, health-related quality of life (HRQoL), and anatomical occlusion., Results: A total of 18 studies were included comprising some 2584 treated limbs. Compression was compared with no compression in four studies, nine studies compared different durations of compression, and a further five compared different types of compression. A 1-2-week period of compression was associated with a mean reduction of 11 (95 per cent c.i. 8 to 13) points in pain score on a 100-mm visual analogue scale compared with a shorter duration (P < 0.001). This was associated with improved HRQoL and patient satisfaction. Longer durations of compression did not add further benefit. There was low-quality evidence suggesting that 35-mmHg compression with eccentric thigh compression achieved lower pain scores than lower interface pressures. There were no significant differences in venous thromboembolism rates or technical success in any group, including no compression., Conclusion: Postprocedural compression of 1-2 weeks after SVI treatment is associated with reduced pain compared with a shorter duration. The optimal interface pressure and type of compression, and the impact on venous thromboembolism risk, remain to be determined., (© The Author(s) 2022. Published by Oxford University Press on behalf of BJS Society Ltd. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Patients suspected to have upper gastrointestinal (UGI) cancer can be referred directly for investigation; however, at times this may result to inappropriate referrals. This study explores the model of a "one-stop" clinic as an alternative to the direct referral system. The current study aims to assess the feasibility and outcomes of a one-stop UGI clinic and evaluate sensitivity and specificity of "on-the-day" diagnoses., Methods: A retrospective analysis of case notes of patients seen in one-stop clinic, between January 2017 and January 2019, was conducted. All General Practitioner (GP) referrals were screened by a specialist nurse., Results: After completion of the post-GP referral screening process, 252 patients (median age 68 years, IQR 58.8-77.3 years; M:F ratio 118:134) were allocated to the one-stop clinic. OGD was not required, contra-indicated or declined in 27 cases (10.7%). The records of three patients could not be found. One patient did not attend. Overall, 221 patients underwent testing and received "on-the-day" diagnoses. Sensitivity was 94% (range 87-100%), and specificity was 92% (88-96%). Ninety-six percent of patients received a diagnosis on the day., Conclusions: The one-stop clinic was feasible and had good specificity and sensitivity. The finding of 10.7% of cases not being suitable for OGD indicates that a patient/specialist consultation is necessary to prevent misuse of endoscopy appointments. The authors recommend widespread adoption of one-stop clinics in UGI surgery., (© 2021. The Author(s).)

Background: Lower limb amputation (LLA) is typically described as 'clean surgery', but surgical-site infection (SSI) rates are high and there is significant variation in antibiotic prophylaxis practice. This study aimed to determine whether an extended period of antibiotic prophylaxis (5-day course) is superior to a short course (24 h) in preventing SSI in patients undergoing minor and major LLA., Methods: Patients undergoing minor and major amputation from a single vascular unit were recruited and randomized to receive either a 5-day or a 24-h prophylactic course of antibiotics. Patients with significant baseline infection were excluded. Outcomes included the incidence of SSI and impaired wound healing (IWH), both measured using ASEPSIS criteria, the need for further surgery, duration of hospital stay, and mortality up to 1 year., Results: Some 161 patients were recruited to the study, and 152 were included in the analysis. A 5-day course of antibiotics was associated with a lower incidence of SSI (11.8 versus 39.5 per cent; P < 0.001) and lower incidence of IWH (22.4 versus 58 per cent; P < 0.001). Fewer patients receiving the 5-day course required amputation revisional surgery (6.6 versus 21 per cent; P = 0.010). Duration of hospital stay and mortality rates were similar. The presence of SSI (odds ratio (OR) 5.14, 95 per cent c.i. 1.96 to 13.45; P < 0.001) and IWH (OR 4.62, 1.68 to 12.72; P = 0.003) increased the need for revisional surgery. SSI increased the duration of hospital stay: median 28 (i.q.r. 16-40) versus 14 (9-21) days (P = 0.045)., Conclusion: SSI and IWH are common after LLA and have a significant impact on outcome. A 5-day course of antibiotic prophylaxis was associated with a reduction in both SSI and IWH compared with a 24-h course, and this reduced the need for further surgery. Registration number: NCT02018094 (http://www.clinicaltrials.gov); EudraCT 2012-003146-32 (https://www.clinicaltrialsregister.eu)., (© The Author(s) 2022. Published by Oxford University Press on behalf of BJS Society Ltd. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Anastomotic bleeding in vascular surgery can be difficult to control. Patients, in particular those undergoing carotid surgery, have often been started on treatment with dual antiplatelet agents and receive systemic heparinization intraoperatively. The use of local hemostatic agents as an adjunct to conventional methods is widely reported. 3-D Matrix's absorbable hemostatic material RADA16 (PuraStat®), is a fully synthetic resorbable hemostatic agent. The aim of this study is to confirm the safety and performance of this agent when used to control intraoperative anastomotic bleeding during carotid endarterectomy (CEA). A prospective, single-arm, multicenter study involving 65 patients, undergoing CEA, in whom the hemostatic agent was applied to the suture line after removal of arterial clamps. Patients were followed up at 24 h, discharge, and one month after surgery. Time to hemostasis was measured as the primary endpoint. Secondary endpoints included hemostasis efficacy and safety outcomes, blood loss, intraoperative and postoperative administration of blood products, and incidence of reoperation for bleeding. A total of 65 cases (51 male and 14 female) undergoing CEA, utilizing patch reconstruction (90. 8%), eversion technique (6.1%), and direct closure (3.1%) were analyzed. All patients received dual antiplatelet therapy preoperatively and were administered systemic intravenous heparin intraoperatively, as per local protocol. The mean time to hemostasis was 83 s ± 105 s (95% CI: 55-110 s). Primary hemostatic efficacy was 90.8%. The mean volume of product used was 1.7 mL ± 1.1 mL. Hemostasis was achieved with a single application of the product in 49 patients (75.3%). Two patients required a transfusion of blood products intraoperatively. There were no blood product transfusions during the postoperative period. The intraoperative mean blood loss was 127 mL ± 111.4 mL and postoperatively, the total mean drainage volume was 49.0 mL ± 51.2 mL. The mean duration of surgery was 119 ± 35 min, and the mean clamp time was 35 min 12 s ± 19 min 59 s. In 90.8% of patients, there was no presence of hematoma at 24 h postoperatively. Three returned to theatre due to bleeding (2 in the first 24 h), however, none of these cases were considered product related. Overall, there were no device-related serious adverse events (SAE) or unanticipated device-related SAEs reported. Use of the hemostatic agent PuraStat® is associated with a high rate of hemostatic efficacy (90.8%) and a short time to hemostasis. The safety of the product for use on vascular anastomoses has been demonstrated.

Background: The majority of surgical wounds are closed (for example with sutures or staples) and so heal by primary intention. Where closure is not possible, or the wound subsequently breaks down, wounds may be left to heal from the bottom up (healing by secondary intention). Surgical wound healing by secondary intention (SWHSI) frequently presents a significant management challenge. Additional treatments are often required during the course of healing, and thus a significant financial burden is associated with treating these wounds. Increasingly, negative pressure wound therapy (NPWT) is used in the management of SWHSI. This wound dressing system provides a negative pressure (vacuum) to the wound, removing fluid into a canister, which is believed to be conducive to wound healing. Despite the increasing use of NPWT, there is limited robust evidence for the effectiveness of this device. A well-designed and conducted randomised controlled trial is now required to ascertain if NPWT is a clinically and cost-effective treatment for SWHSI., Methods: SWHSI-2 is a pragmatic, multi-centre, cross surgical specialty, two arm, parallel group, randomised controlled superiority trial. Adult patients with a SWHSI will be randomised to receive either NPWT or usual care (no NPWT) and will be followed up for 12 months. The primary outcome will be time to healing (defined as full epithelial cover in absence of a scab) in number of days since randomisation. Secondary outcomes will include key clinical events (hospital admission or discharge, treatment status, reoperation, amputation, antibiotic use and death), wound infection, wound pain, health-related quality of life, health utility and resource use., Discussion: Given the increasing use of NPWT, despite limited high-quality supporting evidence, the SWHSI-2 Trial will provide robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI. The SWHSI-2 Trial opened to recruitment in May 2019 and is currently recruiting across 20 participating centres., Trial Registration: ISRCTN 26277546 . Prospectively registered on 25 March 2019., (© 2021. The Author(s).)

Introduction: The Vascular Society of Great Britain and Ireland (VSGBI) Peripheral Arterial Disease Quality Improvement Framework (PAD QIF) stipulates targets for managing patients with chronic limb-threatening ischaemia (CLTI); however, it is unknown whether these are achievable. This survey aims to evaluate contemporary practice for managing CLTI in the UK., Methods: A questionnaire was developed in conjunction with the VSGBI to survey the management of CLTI and canvass opinions on the PAD QIF. The survey was distributed to all consultant members of the VSGBI and through a targeted social media campaign., Results: Forty-seven consultant vascular surgeons based at 36 arterial centres across the UK responded (response rate from arterial centres = 46%). Only 14.3% of centres provided outpatient consultation within the target of seven days from referral, with only one centre providing revascularisation within the target of seven days from consultation. For inpatient management, 31.6% provided surgical and 23.8% endovascular revascularisation within the target of three days from assessment. While 60% of participants believe the PAD QIF's 5-day 'admitted care' pathway is achievable, only 28.6% thought the 14-day 'non-admitted care' pathway was feasible. Challenges to meeting these targets include the availability of theatre space and angiography lists, and availability of outpatient appointments for patient assessment., Conclusions: The opinion of UK vascular surgeons indicates that achieving the targets of the PAD QIF represents a major challenge based upon current services. Adapting existing services with a greater focus on providing an 'urgent' model of care may help to potentially overcome these challenges.

Background: Prompt revascularization in patients with chronic limb-threatening ischaemia (CLTI) is important, and recent guidance has suggested that patients should undergo revascularization within 5 days of an emergency admission to hospital. The aim of this cohort study was to identify factors associated with the ability of UK vascular services to meet this standard of care., Methods: Data on all patients admitted non-electively with CLTI who underwent open or endovascular revascularization between 2016 and 2019 were extracted from the National Vascular Registry. The primary outcome was interval between admission and procedure, analysed as a binary variable (5 days or less, over 5 days). Multivariable Poisson regression was used to examine the relationship between time to revascularization and patient and admission characteristics., Results: The study analysed information on 11 398 patients (5973 open, 5425 endovascular), 50.6 per of whom underwent revascularization within 5 days. The median interval between admission and intervention was 5 (i.q.r. 2-9) days. Patient factors associated with increased risk of delayed revascularization were older age, greater burden of co-morbidity, non-smoking status, presentation with infection and tissue loss, and a Fontaine score of IV. Patients admitted later in the week were less likely undergo revascularization within 5 days than those admitted on Sundays and Mondays (P < 0.001). Delays were slightly worse among patients having open compared with endovascular procedures (P = 0.005) and in hospitals with lower procedure volumes (P < 0.001)., Conclusion: Several factors were associated with delays in time to revascularization for patients with CLTI in the UK, most notably the weekday of admission, which reflects how services are organized. The results support arguments for vascular units providing revascularization to have the resources for a 7-day service., (© The Author(s) 2021. Published by Oxford University Press on behalf of BJS Society Ltd. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Arteriovenous fistulae (AVF) are preferred for dialysis access but require accurate cannulation for effective dialysis. Evidence supports improvements in cannulation and complication rates using ultrasound guidance (USG) in cannulating other sites. This mixed methods, randomised controlled trial aimed to assess effects of USG during AVF cannulation., Methods: Participants with difficult to cannulate AVF had each cannulation event randomised to USG or standard technique (no USG). The primary outcome was the incidence and number of additional needle passes. Secondary outcomes included: the incidence and number of additional skin punctures; time to achieve two needle cannulation; pain associated with cannulation; local complications. Qualitative outcomes were assessed using patient and staff questionnaires., Results: Thirty-two participants had 346 cannulation events randomised (170 to USG and 176 to standard cannulation). USG resulted in a significant reduction in additional needle passes (72 vs 99 p  = 0.007) and additional skin punctures (10 vs 25 p  = 0.016.) but prolonged time to cannulation ( p  > 0.001). There was no difference in pain score ( p  = 0.705) or complications between groups. Questionnaires demonstrated that USG cannulation is acceptable to patients and staff., Conclusion: USG cannulation of AVF is more accurate and no more painful than non-image guided cannulation, but prolonged time to cannulation. Some of the excess time involved may be due to the trial being performed early in cannulating staff's learning curve with the USG technique. Further work to elucidate which patients gain most benefit from USG cannulation and the effect of USG on cannulation complications and AVF patency is warranted.

Objective: This RCT compares the clinical, technical and quality of life outcomes after EVLA and MOCA., Summary of Background Data: Thermal ablation is the current mainstay treatment for SVI. Newer nonthermal methods of treatment have been developed which do not require the use of tumescent anesthesia. The potential advantages of these newer methods should be tested in RCTs to ascertain their role in the future treatments of SVI., Methods: This single-center RCT enrolled patients with symptomatic, unilateral, single-axis SVI. Eligible patients were equally randomized to either EVLA or MOCA, both with concomitant phlebectomy when necessary. The joint primary outcomes were intraprocedural axial ablation pain scores and anatomical occlusion at 1 year. Secondary outcomes included postprocedural pain, venous clinical severity score (VCSS), quality of life (Aberdeen varicose veins questionnaire and EuroQol 5-domain utility index), patient satisfaction and complication rates., Results: One hundred fifty patients were randomized equally between the 2 interventions. Both groups reported low intraprocedural pain scores; on a 100 mm visual analog scale, pain during axial EVLA was 22 (9-44) compared to 15 (9-29) during MOCA; P = 0.210. At 1 year, duplex derived anatomical occlusion rates after EVLA were 63/69 (91%) compared to 53/69 (77%) in the MOCA group; P = 0.020. Both groups experienced significant improvement in VCSS and AVVQ after treatment, without a significant difference between groups. Median VCSS improved from 6 (5-8) to 0 (0-1) at one year; P < 0.001. Median AVVQ improved from 13.8 (10.0-17.7) to 2.0 (0.0-4.9); P < 0.001. One patient in the MOCA group experienced DVT., Conclusions: Both EVLA and MOCA were highly efficacious in treating SVI; patients improved significantly in terms of disease severity, symptoms, and QoL. Both resulted in low procedural pain with a short recovery time. Axial occlusion rates were higher after EVLA. Long term follow-up is warranted to assess the effect of recanalization on the rate of clinical recurrence., Competing Interests: The authors report no conflicts of interest., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The SARS-CoV-2 pandemic had a profound impact on surgical services, potentially having a detrimental impact on training opportunities. The aim of this global survey was to assess the impact of the COVID-19 crisis on surgical training and to develop a framework for recovery., Methods: A cross-sectional, web-based survey was conducted. This was designed by a steering committee of medical educationalists and validated by a group of trainees before dissemination., Results: A total of 608 responses were obtained from 34 countries and 15 specialties. The results demonstrated major disruption in all aspects of training. The impact was greatest for conferences (525 of 608) and hands-on courses (517 of 608), but less for inpatient care-related training (268 of 608). European trainees were significantly more likely to experience direct training disruption than trainees in Asia (odds ratio 0.15) or Australia (OR 0.10) (χ2 = 87.162, P < 0.001). Alternative training resources (webinars, 359 of 608; educational videos, 234 of 608) have emerged, although trainees expressed some dissatisfaction with them. The collective responses generated a four-pillar framework for training recovery that involved: guidance from training stakeholders with the involvement of trainees; prioritization of training, especially the roles of senior surgeons/trainers; provision of access to alternative/new teaching methods; and measures to address trainee anxiety., Conclusion: Training has been greatly affected by the COVID-19 pandemic. The introduction of new teaching methods and a focus on training after the pandemic are imperative., (© The Author(s) 2021. Published by Oxford University Press on behalf of BJS Society Ltd.)

Competing Interests: Competing interests: None declared.

Background: More than 2 million people per year are treated for surgical wounds in the UK.  Over a quarter of these wounds are estimated to heal by secondary intention (from the "bottom up") resulting in further complications and requiring increased healthcare resources. Identification of microbiological or host biomarkers that can predict healing outcomes may help to optimize the management of surgical wounds healing by secondary intention. However, the microbial and host factor heterogeneity amongst this diverse population is completely unexplored. Methods: We demonstrate feasibility of determining presence and levels of wound microbes and systemic host factors in an inception cohort of 54 people presenting with surgical wounds healing by secondary intention, who were subsequently followed-up for a period of 12-21 months. We present descriptive statistics for plasma levels of inflammatory, angiogenic cytokines and microRNAs, and we identify a range of wound colonizing microbes. We tentatively explore association with healing aiming to generate hypotheses for future research. Results: We report a potential correlation between poor healing outcomes and elevated interleukin (IL)-6 plasma levels at presentation (ρ=0.13) which requires confirmation.   Conclusions: This study demonstrates the degree of biological heterogeneity amongst people with surgical wounds healing by secondary intention and proves the feasibility of embedding a biomarker discovery study in a cohort study in surgical wounds. Our results are essential for designing large biomarker discovery studies to further investigate the potential validity of circulating IL-6 or other factors as novel predictive biomarkers of healing for surgical wounds healing by secondary intention., Competing Interests: No competing interests were disclosed., (Copyright: © 2020 Buckley H et al.)

Background: Research nurse involvement in trials is crucial to successful conduct, however their feedback on trial design and conduct is not necessarily always collected and shared. This study was designed to explore research nurse feedback in relation to study and protocol design and implementation in the National Institute for Health Research Programme Grants for Applied Research funded Surgical Wounds Healing by Secondary Intention pilot and feasibility trial (SWHSI). The primary aim of this study was to inform the design and conduct of a proposed future, larger study in this area. Given the evidence gap, it was deemed prudent to share these findings for the benefit of others., Methods: A sequential, dependent mixed methods study, comprising a Likert scale questionnaire and semi-structured interviews, explored the experiences, in relation to study design and conduct, of research nurses involved in the trial. Of the 10 research nurses involved in the trial, eight nurses completed a questionnaire and were interviewed. Questionnaire data was analysed using descriptive statistics and interview data using thematic analysis., Results: A range of questionnaire responses were provided, however at least 50% (n = 4) of respondents indicated that they were happy with both the study design and conduct. Interview data identified key themes to consider when involving research nurses in the design, delivery and conduct of RCTs; removing barriers to recruitment, time management, engagement strategies and resource provision., Conclusion: Engagement of research nurses is important to enable effective trial conduct. Research teams should therefore consider how best to obtain and include input from all members of the research team from the outset. Furthermore, the sharing of feedback on research design and conduct, from the perspective of research nurses delivering trial recruitment and retention, remains crucial to effective and efficient trial conduct., Trial Registration: Clinical Trial Registry: ISRCTN12761776. Date of registration: 10th December 2015., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)

We investigated factors that affected perioperative, postoperative, and long-term outcomes of patients who underwent open emergency surgical repair of ruptured abdominal aortic aneurysms (RAAA). All patients who underwent open emergency surgical repair from 1990 to 2011 were included (463 patients; 374 [81%] male; mean age 74.7 ± 8.7years). Logistic and Cox regression analyses were performed to explore the association of variables with outcomes. Preoperatively, median (interquartile range) hemoglobin was 11.2 (9.5-12.8) g/dL, and median creatinine level was 140 (112-177) µmol/L. Intraoperatively, the median operative time was 2.25 (2-3) hours, and median estimated blood loss was 1.5 (0.5-3) L; 250 (54%) patients required intraoperative inotropes, and a median of 6 (4-8) units of blood was transfused. Median length of hospital stay was 11 (7-20) days. In-hospital mortality rate was 35.6%, and 5-year mortality was 48%. Age, distance traveled, operation duration, postoperative myocardial infarction (MI), and multi-organ failure (MOF) were predictors of in-hospital mortality and long-term outcome. Additionally, postoperative acute renal failure predicted in-hospital mortality. In patients with RAAA undergoing open surgical repair, the strongest predictors of in-hospital mortality and long-term outcome were postoperative MOF and MI and operative duration.

Aims and Objectives: To explore surgeons' and nurses' perspectives of managing surgical wounds healing by secondary intention., Background: Every year, more than 10 million surgical operations are performed in the NHS in the UK. Most surgical wounds heal by primary intention, where the edges of the wound are brought together with staples, sutures, adhesive glue or clips. Sometimes wounds are deliberately left open to heal, from the base up, known as "healing by secondary intention." These wounds are often slow to heal, prone to infection and complex to manage., Design: A qualitative, descriptive approach, using semi-structured interviews., Methods: Interviews with five (general, vascular and plastic) surgeons and 7 nurses (3 tissue viability nurses, 2 district and 1 community nurse, and 1 hospital nurse) working in hospital and community care settings in two locations in the north of England. Data analysis followed the recommended sequential steps of "Framework" approach. Consolidated criteria for reporting qualitative research guided the study report., Results: Participants reported that the main types of wounds healing by secondary intention that they manage are extensive abdominal cavity wounds; open wounds relating to treatment for pilonidal sinus; large open wounds on the feet of patients with diabetes; and axilla and groin wounds, associated with removal of lymph nodes for cancer. Infection and prolonged time to healing were the main challenges. Negative pressure wound therapy was the most favoured treatment option., Conclusions: Negative pressure wound therapy was advocated by professionals despite a lack of research evidence indicating clinical or cost-effectiveness. Our findings underscore the need for rigorous evaluation of negative pressure wound therapy, and other wound care treatments, through studies that include economic evaluation., Relevance for Clinical Practice: Clinical decision-making in wound care could be optimised through further robust studies to inform practitioners about the cost-effectiveness of available treatments., (© 2020 The Authors. Journal of Clinical Nursing published by John Wiley & Sons Ltd.)

Introduction: Open surgical ligation and stripping of the great saphenous vein is a highly cost-effective treatment when compared with conservative management and foam sclerotherapy but has limitations including post-operative morbidity and pain. This study aims to identify if the addition of tumescent anaesthesia could improve patient outcomes following treatment., Methods: Patients with primary superficial venous incompetence undergoing open surgical ligation and stripping of the great saphenous vein were randomised to either General Anaesthesia (GA) alone (GA) procedure or the addition of tumescent (G + T). The primary outcome was bodily pain (within SF-36) at one week. Additional outcomes included post-procedural pain score (100 mm visual analogue scale), complications and quality of life., Results: A total of 90 patients were randomised for inclusion. There was no significant difference in primary outcome; bodily pain at one week. Secondary outcome of 4-h post-procedural scores were significantly lower in the G + T group (32 (20-54) mm vs. (GA alone) 56 (24-70) mm (P = 0.016)). Complications were minor and equivalent. Both groups saw a significant increase (worsening) in Aberdeen Varicose Vein Questionnaire scores at week 1 with the G + T group faring worse at six weeks (10.0 (Interquartile Range [IQR] 5.6-17.9) vs. 4.3 (IQR 2.7-7.9) P = 0.004)., Conclusion: The G + T group did not demonstrate a significant difference in the one-week bodily pain domain. The addition of tumescent anaesthesia does improve immediate post-operative pain but appears to negatively impact on six-week quality of life. EudraCT Number: 2011-005574-39.

Introduction: Diabetes affects more than 425 million people worldwide with a lifetime risk of diabetic foot ulcer (DFU) of up to 25%. Management includes wound debridement, wound dressings, offloading, treatment of infection and ischaemia, optimising glycaemic control; use of advanced adjuvant therapies is limited by high cost and lack of robust evidence., Methods and Analysis: A multicentre, seamless phase II/III, open, parallel group, multi-arm multi-stage randomised controlled trial in patients with a hard-to-heal DFU, with blinded outcome assessment. A maximum of 447 participants will be randomised (245 participants in phase II and 202 participants in phase III). The phase II primary objective will determine the efficacy of treatment strategies including hydrosurgical debridement ± decellularised dermal allograft, or the combination with negative pressure wound therapy, as an adjunct to treatment as usual (TAU), compared with TAU alone, with patients randomised in a 1:1:1:2 allocation. The outcome is achieving at least 50% reduction in index ulcer area at 4 weeks post randomisation.The phase III primary objective will determine whether one treatment strategy, continued from phase II, reduces time to healing of the index ulcer compared with TAU alone, with participants randomised in a 1:1 allocation. Secondary objectives will compare healing status of the index ulcer, infection rate, reulceration, quality of life, cost-effectiveness and incidence of adverse events over 52 weeks post randomisation. Phase II and phase III primary endpoint analysis will be conducted using a mixed-effects logistic regression model and Cox proportional hazards regression, respectively. A within-trial economic evaluation will be undertaken; the primary economic analysis will be a cost-utility analysis presenting ICERs for each treatment strategy in rank order of effectiveness, with effects expressed as quality-adjusted life years.The trial has predefined progression criteria for the selection of one treatment strategy into phase III based on efficacy, safety and costs at 4 weeks., Ethics and Dissemination: Ethics approval has been granted by the National Research Ethics Service (NRES) Committee Yorkshire and The Humber - Bradford Leeds Research Ethics Committee; approved 26 April 2017; (REC reference: 17/YH/0055). There is planned publication of a monograph in National Institute for Health Research journals and main trial results and associated papers in high-impact peer-reviewed journals., Trial Registration Number: ISRCTN64926597; registered on 6 June 2017., Competing Interests: Competing interests: AC and RLom are employees of NHS Blood and Transplant who provide the DCD., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Background: Endovenous laser ablation and ultrasound-guided foam sclerotherapy are recommended alternatives to surgery for the treatment of primary varicose veins, but their long-term comparative effectiveness remains uncertain., Methods: In a randomized, controlled trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of laser ablation, foam sclerotherapy, and surgery. Primary outcomes at 5 years were disease-specific quality of life and generic quality of life, as well as cost-effectiveness based on models of expected costs and quality-adjusted life-years (QALYs) gained that used data on participants' treatment costs and scores on the EuroQol EQ-5D questionnaire., Results: Quality-of-life questionnaires were completed by 595 (75%) of the 798 trial participants. After adjustment for baseline scores and other covariates, scores on the Aberdeen Varicose Vein Questionnaire (on which scores range from 0 to 100, with lower scores indicating a better quality of life) were lower among patients who underwent laser ablation or surgery than among those who underwent foam sclerotherapy (effect size [adjusted differences between groups] for laser ablation vs. foam sclerotherapy, -2.86; 95% confidence interval [CI], -4.49 to -1.22; P<0.001; and for surgery vs. foam sclerotherapy, -2.60; 95% CI, -3.99 to -1.22; P<0.001). Generic quality-of-life measures did not differ among treatment groups. At a threshold willingness-to-pay ratio of £20,000 ($28,433 in U.S. dollars) per QALY, 77.2% of the cost-effectiveness model iterations favored laser ablation. In a two-way comparison between foam sclerotherapy and surgery, 54.5% of the model iterations favored surgery., Conclusions: In a randomized trial of treatments for varicose veins, disease-specific quality of life 5 years after treatment was better after laser ablation or surgery than after foam sclerotherapy. The majority of the probabilistic cost-effectiveness model iterations favored laser ablation at a willingness-to-pay ratio of £20,000 ($28,433) per QALY. (Funded by the National Institute for Health Research; CLASS Current Controlled Trials number, ISRCTN51995477.)., (Copyright © 2019 Massachusetts Medical Society.)

Objective: To assess the clinical efficacy of a neuromuscular electrical stimulation (NMES) device to improve the absolute walking distance in patients with intermittent claudication as an adjunct to the local standard care available at the study sites compared with local standard care alone., Methods: This open, multicenter, randomized controlled trial included eight participating centers in England. Sites are equally distributed between those that provide supervised exercise therapy programs and those that do not. Patients with intermittent claudication meeting the eligibility criteria and providing consent will be randomized, depending on the center type, to either NMES and locally available standard care or standard care alone. The primary end point is change in absolute walking distance at 3 months (the end of the intervention period) by treadmill testing. Secondary outcomes include quality of life, compliance with the interventions, economic evaluation of the NMES device, and lower limb hemodynamic measures to further the understanding of underlying mechanisms. Recruitment commenced in March 2018 and will continue for a total of 15 months. The Neuromuscular Electrical Stimulation Improves the Absolute Walking Distance in Patients with Intermittent Claudication trial is funded by the UK Efficacy and Mechanism Evaluation Programme, Medical Research Council, and National Institute for Health Research partnership., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Clinical guidelines recommend endovenous laser ablation (EVLA) over surgery based on short-term evidence, yet there are few studies reporting mid- to long-term outcomes. The aim of this study was to report the 5-year outcomes from an RCT of surgery versus EVLA for treatment of symptomatic great saphenous varicose veins., Methods: Patients with symptomatic varicose veins due to great saphenous vein (GSV) incompetence were followed up 5 years after enrolment in a randomized trial of either surgery (saphenofemoral junction ligation, GSV strip to the knee and multiple avulsions of varicosities) or EVLA plus multiple avulsions. Outcomes included: clinical recurrence, defined as new varicose veins greater than 3 mm in diameter; Venous Clinical Severity Score (VCSS); quality of life measured by means of Short Form 36, EuroQol Five Dimensions (EQ-5D™) and Aberdeen Varicose Vein Questionnaire (AVVQ); patient satisfaction; and duplex ultrasound examination (DUS) findings., Results: Some 218 of the 276 patients enrolled in the trial (79·0 per cent) were available for follow-up. Clinical recurrence was more frequent following surgery than EVLA at 5 years (34·3 versus 20·9 per cent; P = 0·010). Both groups demonstrated sustained significant improvements at 5 years over baseline in VCSS (surgery: median (i.q.r.) 1 (0-2) from 4 (3-5), P < 0·001; EVLA: 0 (0-1) from 4 (3-5), P < 0·001), AVVQ (surgery: 4·59 (0·56-9·78) from 13·69 (9·81-18·11), P < 0·001; EVLA: 3·35 (0·17 to 6·55) from 12·73 (9·41-17·32), P < 0·001) and EQ-5D™ (surgery: 1·000 (0·796-1·000) from 0·859 (0·796-1·000), P = 0·002; EVLA: 1·000 (0·796-1·000) from 0·808 (0·796-1·000), P = 0·002). VCSS was better for EVLA than surgery at 5 years (P = 0·031). Technical success assessed by DUS remained high at 5 years (85·4 per cent for surgery and 93·2 per cent for EVLA; P = 0·074). DUS-detected anatomical patterns of recurrence differed between the groups., Conclusion: EVLA was more effective than surgery in preventing clinical recurrence 5 years after treatment of great saphenous varicose veins. Patient-reported outcome measures were similar. Registration number: NCT00759434 (http://www.clinicaltrials.gov)., (© 2018 BJS Society Ltd Published by John Wiley & Sons Ltd.)

Objective/background: Endovenous thermal ablation (EVTA) is the recommended first line intervention for superficial venous incompetence (SVI). While the infiltration of perivenous tumescent local anaesthesia (TLA) is key to procedural success, it is paradoxically the predominant source of patient reported discomfort. This randomised controlled trial investigates the potential to reduce peri-procedural pain and improve patient reported outcome measures (PROMs), including quality of life (QoL) using TLA buffered to physiological pH., Methods: Patients undergoing great saphenous vein EVTA with concomitant phlebectomies were randomised to either standard (ST) or buffered (BT) TLA. Follow up assessments were performed at weeks 1, 6, and 12. The primary outcome was patient reported peri-procedural pain on a 100 mm visual analogue scale (VAS). Secondary outcomes were one week post-procedural pain VAS and analgesia use, QoL (disease specific: Aberdeen Varicose Vein Questionnaire [AVVQ]; generic: Short Form-36 [SF-36] and EuroQol 5 Dimensions Questionnaire [EQ-5D]), patient satisfaction VAS, technical success on duplex ultrasound (DUS) examination, and complications., Results: Ninety-seven patients were randomised: 50 to ST and 47 to BT. The groups had comparable baseline demographics, Clinical Etiologic Anatomic Pathological, Venous Clinical Severity Score, QoL, and DUS parameters. Equally, intra-procedural parameters (volume of TLA, length of ablation, and linear energy delivered) were also comparable. Peri-procedural pain scores were significantly lower in the BT group with a mean ± SD score of 2.86 ± 3.57 versus 4.44 ± 2.94 (p = .001). Pain scores and analgesia use over the subsequent week were equivalent. SF-36 Bodily Pain domain scores were significantly better in the BT group at week 1 (77 vs. 62; p = .008). AVVQ, SF-36, and EQ-5D scores were otherwise similar between the groups throughout follow up, significantly improving over baseline. Technical success was high in both groups, with no major complications and few minor complications., Conclusion: Buffered TLA offers a significantly lower peri-procedural pain experience for patients undergoing EVTA and should replace current tumescent formulae., (Copyright © 2018. Published by Elsevier B.V.)

Background: Venous leg ulcers (VLUs) are the most common cause of leg ulceration, affecting 1 in 100 adults. VLUs may take many months to heal (25% fail to heal). Estimated prevalence is between 1% and 3% of the elderly population. Compression is the mainstay of treatment and few additional therapies exist to improve healing. Two previous trials have indicated that low-dose aspirin, as an adjunct to standard care, may improve healing time, but these trials were insufficiently robust. Aspirin is an inexpensive, widely used medication but its safety and efficacy in the treatment of VLUs remains to be established., Objectives: Primary objective - to assess the effects of 300 mg of aspirin (daily) versus placebo on the time to healing of the reference VLU. Secondary objectives - to assess the feasibility of leading into a larger pragmatic Phase III trial and the safety of aspirin in this population., Design: A multicentred, pilot, Phase II randomised double-blind, parallel-group, placebo-controlled efficacy trial., Setting: Community leg ulcer clinics or services, hospital outpatient clinics, leg ulcer clinics, tissue viability clinics and wound clinics in England, Wales and Scotland., Participants: Patients aged ≥ 18 years with a chronic VLU (i.e. the VLU is > 6 weeks in duration or the patient has a history of VLU) and who are not regularly taking aspirin., Interventions: 300 mg of daily oral aspirin versus placebo. All patients were offered care in accordance with Scottish Intercollegiate Guidelines Network (SIGN) guidance with multicomponent compression therapy aiming to deliver 40 mmHg at the ankle when possible., Randomisation: Participants were allocated in a 1 : 1 (aspirin : placebo) ratio by the Research Pharmacy, St George's University Hospitals NHS Foundation Trust, using a randomisation schedule generated in advance by the investigational medicinal product manufacturer. Randomisation was stratified according to ulcer size (≤ 5cm 2 or > 5cm 2 )., Main Outcome Measure: The primary outcome was time to healing of the largest eligible ulcer (reference ulcer)., Feasibility Results – Recruitment: 27 patients were recruited from eight sites over a period of 8 months. The target of 100 patients was not achieved and two sites did not recruit. Barriers to recruitment included a short recruitment window and a large proportion of participants failing to meet the eligibility criteria., Results: The average age of the 27 randomised participants (placebo, n  = 13; aspirin, n  = 14) was 62 years (standard deviation 13 years), and two-thirds were male ( n  = 18). Participants had their reference ulcer for a median of 15 months, and the median size of ulcer was 17.1 cm 2 . There was no evidence of a difference in time to healing of the reference ulcer between groups in an adjusted analysis for log-ulcer area and duration (hazard ratio 0.58, 95% confidence interval 0.18 to 1.85; p  = 0.357). One expected, related serious adverse event was recorded for a participant in the aspirin group., Limitations: The trial under-recruited because many patients did not meet the eligibility criteria., Conclusions: There was no evidence that aspirin was efficacious in hastening the healing of chronic VLUs. It can be concluded that a larger Phase III (effectiveness) trial would not be feasible., Trial Registration: Clinical Trials.gov NCT02333123; European Clinical Trials Database (EudraCT) 2014-003979-39., 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. 22, No. 55. See the NIHR Journals Library website for further project information., Competing Interests: Catriona McDaid is a member of the National Institute for Health Research Health Technology Assessment and Efficacy and Mechanism Evaluation Editorial Board. Christine Moffatt has received grant funding from 3M UK PLC and Smith and Nephew, two health science-based technology companies, outside the submitted work.

Background: Varicose veins impair quality of life and can lead to chronic leg ulcers. National Institute for Health and Care Excellence (NICE) guidelines (CG168) set out evidence-based standards for patient management. In England, Clinical Commissioning Groups (CCGs) fund NHS care within their locality. The objective of this study was to evaluate CCGs' commissioning policies and compare them with CG168., Methods: Searches were made for the published policies of all 206 English CCGs. They were reviewed for compliance with NICE guidelines and the associated quality standard. Areas of disagreement were analysed for themes., Results: Some 203 CCGs (98·5 per cent) had a published policy and 190 (93·6 per cent) of these were published after publication of CG168. Only 73 of the policies (36·0 per cent) were compliant with CG168. Treatment was restricted on the basis of clinical disease severity in 119 CCGs (58·6 per cent); 29 (14·3 per cent) stipulated delay of treatment using a 'trial' of conservative treatment; 22 (10·8 per cent) used lifestyle-related factors such as BMI and smoking status to ration treatment. Treatment was commissioned for uncomplicated symptomatic varicose veins in 87 CCGs (42·9 per cent), but some applied additional rationing mechanisms; 109 CCGs (53·7 per cent) would treat oedema, 183 (90·1 per cent) would treat skin and soft tissue damage, 202 (99·5 per cent) healed ulceration, and all would allow active ulcers to be treated., Discussion: The majority of CCGs in England have commissioning policies that contradict NICE guidelines. Rationing strategies include disease severity, delay and patient lifestyle-related factors, creating unwarranted geographical variation for varicose vein treatment, disregarding the NHS Constitution for England, and perhaps leading to an increase in costly treatment of chronic complications in the long term.

Background: Surgical wounds healing by secondary intention (SWHSI) are increasingly being treated with negative-pressure wound therapy (NPWT) despite a lack of high-quality research evidence regarding its clinical and cost-effectiveness. This pilot feasibility RCT aimed to assess the methods for and feasibility of conducting a future definitive RCT of NPWT for the treatment of SWHSI., Methods: Eligible consenting adult patients receiving care at the study sites (2 acute and 1 community) and with a SWHSI appropriate for NPWT or wound dressing treatment were randomized 1 : 1 centrally to receive NPWT or usual care (no NPWT). Participants were followed up every 1-2 weeks for 3 months. Feasibility (recruitment rate, time to intervention delivery) and clinical (time to wound healing) outcomes were assessed., Results: A total of 248 participants were screened for eligibility; 40 (16·1 per cent) were randomized, 19 to NPWT and 21 to usual care. Twenty-four of the 40 wounds were located on the foot. Participants received NPWT for a median of 18 (range 0-72) days. Two participants in the NPWT group never received the intervention and 14 received NPWT within 48 h of randomization. Five participants in the usual care group received NPWT during the study. Ten of the 40 wounds were deemed to have healed during the study., Conclusion: A full-scale RCT to investigate the clinical and cost-effectiveness of NPWT for SWHSI is feasible. This study identified crucial information on recruitment rates and data collection methods to consider during the design of a definitive RCT. Registration number: ISRCTN12761776 (http://www.iscrtn.com).

Background: Most surgical wounds heal by primary intention, that is to say, the edges of the wound are brought together with sutures, staples, adhesive glue or clips. However, some wounds may be left open to heal (if there is a risk of infection, or if there has been significant tissue loss), and are known as 'surgical wounds healing by secondary intention'. They are estimated to comprise approximately 28% of all surgical wounds and are frequently complex to manage. However, they are under researched and little is known of their impact on patients' lives., Objectives: To explore patients' views and experiences of living with a surgical wound healing by secondary intention., Design: A qualitative, descriptive approach., Settings: Participants were recruited from acute and community nursing services in two locations in the North of England characterised by high levels of deprivation and diverse populations., Participants: Participants were aged 18 years or older and had at least one surgical wound healing by secondary intention, which was slow to heal. Purposeful sampling was used to include patients of different gender, age, wound duration and type of surgery (general, vascular and orthopaedic). Twenty people were interviewed between January and July 2012., Methods: Semi-structured interviews were conducted, guided by use of a topic guide developed with input from patient advisors. Data were thematically analysed using steps integral to the 'Framework' approach to analysis, including familiarisation with data; development of a coding scheme; coding, charting and cross comparison of data; interpretation of identified themes., Findings: Alarm, shock and disbelief were frequently expressed initial reactions, particularly to "unexpected" surgical wounds healing by secondary intention. Wound associated factors almost universally had a profound negative impact on daily life, physical and psychosocial functioning, and wellbeing. Feelings of frustration, powerlessness and guilt were common and debilitating. Patients' hopes for healing were often unrealistic, posing challenges for the clinicians caring for them. Participants expressed dissatisfaction with a perceived lack of continuity and consistency of care in relation to wound management., Conclusions: Surgical wounds healing by secondary intention can have a devastating effect on patients, both physical and psychosocial. Repercussions for patients' family members can also be extremely detrimental, including financial pressures. Health care professionals involved in the care of patients with these wounds face multiple, complex challenges, compounded by the limited evidence base regarding cost-effectiveness of different treatment regimens for these types of wounds., (Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Anastomotic or "stitch hole" bleeding is common during vascular surgery with synthetic material such as Dacron or polytetrafluoroethylene. Hemostatic adjuncts such as fibrin sealant (FS) may reduce blood loss and operating time in such circumstances. We evaluated the safety and the hemostatic effectiveness of a ready-to-use human plasma-derived FS in vascular surgery., Methods: Patients with mild/moderate suture line bleeding during elective, open, vascular surgery using synthetic grafts or patches were studied. In an initial Exploratory Study, all patients were treated with FS Grifols, and in a subsequent Primary Study were randomized in a 2:1 ratio to FS Grifols or manual compression (MC). The primary efficacy end point was time to hemostasis (TTH), assessed at defined intervals from the start of treatment application, during a 10-min observational period. Safety end points (in Exploratory + Primary Studies) included adverse events (AEs), vital signs, physical assessments, common clinical laboratory tests (coagulation, complete blood count, serum clinical chemistry parameters, microscopic urinalysis), viral markers, and immunogenicity., Results: In the Primary Study, the proportion of patients who achieved hemostasis at the 3-min time point was higher in the FS Grifols group (46.4%, n = 51/110) than in the MC group (26.3%, n = 15/57) (P < 0.05). The benefit was maintained at successive time intervals: 69 FS Grifols patients (62.7%) and 18 MC patients (31.6%) at 4 min; 82 FS Grifols patients (74.5%) and 28 MC patients (49.1%) at 5 min. The differences between the groups persisted for TTH ≤ 7 min and TTH ≤ 10 min. Treatment failure was reported for 13 FS Grifols patients (11.8%) and 16 MC patients (28.1%). TTH was shorter after FS Grifols application than after MC application. Differences were statistically significant in favor of FS Grifols for each TTH category and for the overall comparison (P < 0.001) as well as for each TTH category (cumulative) and for treatment failure (P = 0.016). Overall, AE experience and types of AEs reported were those expected in this patient population and were similar between the 2 treatment groups. The most frequently reported AEs were procedural pain (59.9% and 69.2% of patients in the FS Grifols [n = 72 + 111] and MC [n = 57] groups, respectively) and nausea (23.5% and 19.2% of patients, respectively)., Conclusions: FS Grifols was efficacious and safe as an adjunct to anastomotic hemostasis in patients undergoing arterial surgery using prosthetic material with mild to moderate bleeding., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

A 70-year-old man with left lower limb critical ischaemia was admitted to our vascular unit for a femoral-popliteal bypass. He had experienced a skin reaction to chlorhexidine 6 months previously during an angioplasty procedure. After intubation, once in the operating theatre, the patient had a urinary catheter inserted using Instillagel. Around 30 min later the patient had a full-blown anaphylactic reaction that required aggressive medical management and the abandoning of surgery. Postoperative allergy testing confirmed that the suspected primary trigger for the anaphylaxis was indeed chlorhexidine, which was present in Instillagel. The patient was also found to have allergies to atracurium and teicoplanin, which had been given on induction. This case report highlights the importance of recognising that Instillagel contains chlorhexidine, and that indeed intraurethral use during routine urinary catheterisation can be a cause of life-threatening anaphylaxis., Competing Interests: Competing interests: None declared., (© BMJ Publishing Group Ltd (unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objectives To produce a tumescent anaesthesia solution with physiological pH for endovenous thermal ablation and evaluate its influence on peri- and postoperative pain, clinical and quality of life outcomes, and technical success. Methods Tumescent anaesthetic solution (0.1% lidocaine with 1:2,000,000 epinephrine) was titrated to physiological pH by buffering with 2 ml incremental aliquots of 8.4% sodium bicarbonate. Patients undergoing great saphenous vein endovenous laser ablation and ambulatory phlebectomy were studied before and after introduction of buffered tumescent anaesthetic. Primary outcome was perioperative pain measured on a 10 cm visual analogue scale. Secondary outcomes were daily pain scores during the first postoperative week, complications, time to return to normal activity, patient satisfaction, generic and disease-specific quality of life, and technical success. Patients were assessed at baseline, and at 1, 6 and 12 weeks following the procedure. Results A physiological pH was achieved with the addition of 10 ml of 8.4% sodium bicarbonate to 1 l of standard tumescent anaesthetic solution. Sixty-two patients undergoing great saphenous vein endovenous laser ablation with phlebectomy were recruited before and after the introduction of buffered tumescent anaesthetic solution. Baseline and operative characteristics were well matched. The buffered solution was associated with significantly lower (median (interquartile range)) periprocedural pain scores (1 (0.25-2.25) versus 4 (3-6), p < 0.001) and postoperative pain score at the end of the treatment day (1.8 (0.3-2.8) versus 3.0 (1.2-5.2), p = 0.033). There were no significant differences in postoperative pain scores between the groups at any other time. There were no significant differences in other clinical outcomes between the groups. Both groups demonstrated significant improvements in generic and disease-specific quality of life, with no intergroup differences. Both groups demonstrated 100% ultrasonographic technical success at all time points. Conclusions Buffering of tumescent anaesthetic solution during endovenous thermal ablation is a simple, safe, inexpensive and effective means of reducing perioperative and early postoperative pain.

Background The intraoperative anatomy of the saphenofemoral junction can vary from the 'textbook' description of six independent proximal tributaries: three medial - superficial external pudendal, deep external pudendal and the posteromedial thigh branch - and three lateral - superficial epigastric, superficial circumflex iliac and the anterolateral thigh branch. Varicose veins can recur following inadequate initial open surgery with failure to identify, ligate and divide these tributaries. An appreciation of common anatomical variations could minimise recurrence rates following surgery. This study aimed to identify common anatomical variations within our patient cohort. Methods This prospective observational study documented diagrammatically the anatomy of saphenofemoral junction in a consecutive series of 172 patients undergoing unilateral, primary saphenofemoral junction ligation for symptomatic superficial venous insufficiency. Diagrams recorded the number of tributaries and their relationship to the saphenofemoral junction, the existence of bifid systems and the relationship of the external pudendal artery to the saphenofemoral junction. Results In sum, 110 women and 62 men with a mean age of 47.2 (IQR 21-77) years were studied. The median number of saphenofemoral junction tributaries was 4 (IQR 0-7). In 74 cases (43.0%), at least one tributary drained directly into the common femoral vein (IQR 0-4), commonly the deep external pudendal (91.9%). The anterolateral thigh branch was identified in 62 cases (35.8%) and the posteromedial thigh branch in 93 cases (53.8%). The external pudendal artery was identified in 150 cases (87.2%) and was superficial to the great saphenous vein in 36 cases (20.9%). Conclusions Significant variations exist in the saphenofemoral junction anatomy. Familiarity with anatomical saphenofemoral junction variations is imperative to ensure operative success and reduce recurrence. Thorough dissection of the common femoral vein is necessary not only to ensure all proximal tributaries are identified and ligated but also as a safety mechanism in preventing avulsion trauma of direct common femoral vein tributaries.

Background: Most incisions following surgery heal by primary intention, with the edges of the wound apposed with sutures or clips. However, some wounds may break open or be left to heal from the bottom up (i.e. healing by secondary intention). Surgical Wounds Healing by Secondary Intention (SWHSI) are often more complex to manage, and require additional treatments during the course of healing. There is significant uncertainty regarding the best treatment for these complex wounds, with limited robust evidence regarding the clinical and cost-effectiveness of different dressings and treatments; one such treatment is Negative Pressure Wound Therapy (NPWT) which is frequently used in the management of SWHSI. Previous randomised controlled trials (RCTs) of NPWT have failed to recruit to time and target, thus we aimed to conduct a pilot RCT to assess the feasibility of conducting a future, full-scale RCT., Methods: This pilot RCT will test the methods and feasibility of recruiting, randomising, and retaining participants into a larger trial of NPWT verses usual care for patients with SWHSI. Participants will be randomised to receive either NPWT or usual care (no NPWT) and will be followed up for 3 months., Discussion: This study will provide a full assessment of methods for, and feasibility of, recruiting, randomising, and retaining patients with SWHSI in a trial of NPWT versus usual care. On the basis of this pilot trial, a full trial may be proposed in the future which will provide additional, robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI., Trial Registration: Clinical Trial Registry: ISRCTN12761776 , registered on 10 December 2015 - retrospective registration.

Background: Extracorporeal shockwave therapy (ESWT) is emerging as a potential new treatment option for a variety of clinical scenarios including promotion of wound healing and symptom control in end-stage ischemic heart disease. A number of small trials have investigated ESWT in the management of peripheral arterial disease (PAD). A systematic review of the literature was performed investigating the efficacy and potential mechanism of action of ESWT for PAD., Methods: A systematic review was conducted using MEDLINE and PubMed databases in keeping with the standard reporting guidelines set by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis group to identify any publications relating to the use of ESWT in PAD., Results: Systematic literature review identified 5 studies in 4 articles investigating ESWT in the treatment of symptomatic PAD. Although participant numbers within the identified studies were small, significant improvements in pain-free walking distance and maximum walking distance were demonstrated. The mechanism of action is thought to be due to mechanotransduction and subsequent angiogenesis., Conclusions: ESWT shows promise as a potentially efficacious novel treatment for symptomatic PAD. However, studies to date are small and record heterogeneous outcomes. Appropriately powered, randomized, sham-controlled data including objective clinical outcomes to comprehensively assess the efficacy of this novel treatment modality is still required before determining if ESWT should be brought into routine clinical practice., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Intermittent claudication (IC) is a common condition which is associated with significant quality of life limitation. National Institute for Health and Care Excellence guidelines recommend a group-based supervised exercise program as the primary treatment option for claudication, based on clinical and cost effectiveness. This review aims to assess the mechanisms by which exercise improves outcomes in patients with IC., Methods: MEDLINE, EMBASE, and PubMed were searched using the search strategy "claudication" [AND] "exercise" [AND] "mechanisms." Searches were limited from 1947 to October 2014. Only full-text articles published in the English language in adults (over 18 years of age) were eligible for the review. Any trial involving a nonsupervised exercise program was excluded. Abstracts identified by the database search were interrogated for relevance and citations from the shortlisted papers were hand searched for relevant references., Results: The search yielded a total of 112 studies, of which 42 were duplicates. Forty-seven of the remaining 70 were deemed appropriate for inclusion in the review. Exercise is the first-line treatment for IC. Supervised exercise programs improve walking distances, endothelial and mitochondrial function, muscle strength, and endurance. Furthermore, it leads to a generalized improvement in cardiovascular fitness and overall quality of life., Conclusions: The mechanism by which exercise improves outcome in claudicants is complicated and multifactorial. Further research is required in this area to fully elucidate the precise and predominant mechanisms and to assess whether targeted exercise program modification maximizes mechanism efficacy and patient outcome., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Venous leg ulcers (VLUs) are the commonest cause of leg ulceration, affecting 1 in 100 adults. There is a significant health burden associated with VLUs - it is estimated that the cost of treatment for 1 ulcer is up to £1300 per year in the NHS. The mainstay of treatment is with graduated compression bandaging; however, treatment is often prolonged and up to one quarter of venous leg ulcers do not heal despite standard care. Two previous trials have suggested that low-dose aspirin, as an adjunct to standard care, may hasten healing, but these trials were small and of poor quality. Aspirin is an inexpensive, widely used medication but its safety and efficacy in the treatment of VLUs remains to be established., Methods/design: AVURT is a phase II randomised double blind, parallel-group, placebo-controlled efficacy trial. The primary objective is to examine whether aspirin, in addition to standard care, is effective in patients with chronic VLUs (i.e. over 6 weeks in duration or a history of VLU). Secondary objectives include feasibility and safety of aspirin in this population. A target of 100 participants, identified from community leg ulcer clinics and hospital clinics, will be randomised to receive either 300 mg of aspirin once daily or placebo. All participants will receive standard care with compression therapy. The primary outcome will be time to healing of the reference ulcer. Follow-up will occur for a maximum of 27 weeks. The primary analysis will use a Cox proportional hazards model to compare time to healing using the principles of intention-to-treat. Secondary outcomes will include ulcer size, pain evaluation, compliance and adverse events., Discussion: The AVURT trial will investigate the efficacy and safety of aspirin as a treatment for VLU and will inform on the feasibility of proceeding to a larger phase III study. This study will address the paucity of information currently available regarding aspirin therapy to treat VLU., Trial Registration: The study is registered on a public database with clinicaltrials.gov ( NCT02333123 ; registered on 5 November 2014).

Laser ablation involves the delivery of laser light through a glass fibre placed into the lumen of a refluxing vein. This energy is converted into heat inducing a permanent, non-thrombotic occlusion. This highly effective and safe approach has significant advantages over traditional surgical treatment and has driven the endovenous revolution in the management of varicose veins. This chapter will explore the mechanism of action, present the evidence of laser' clinical and cost effectiveness, and analyse specific and generic aspects of laser ablation technique., (© The Author(s) 2015.)