Imperial College London


Faculty of MedicineDepartment of Surgery & Cancer

Clinical Trials Manager



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Publication Type

12 results found

Heatley F, Onida S, Davies AH, 2020, The global management of leg ulceration: Pre early venous reflux ablation trial, Phlebology, Pages: 1-7, ISSN: 0268-3555

BackgroundVarious guidelines exist worldwide for the diagnosis and management of venous leg ulcers; however, these are difficult to implement resulting in disparate treatment of patients globally.MethodAn online, 26-question survey was designed to evaluate the current global management of venous leg ulceration and was emailed globally to approximately 15,000 participants (November 2017–February 2018).ResultsOverall, 799 responses were received from 86 countries, with a 5% response rate. The respondent physicians saw a median of 10 (interquartile range 5–20) patients per month, with a median time to referral from primary to secondary care of six weeks. Of the respondents, 61% arranged an ankle brachial pressure index on first visit and 84% performed a venous duplex, with 95% prescribing compression for those in whom it was not contraindicated. Fifty-nine percent performed endovenous intervention or surgery prior to ulcer healing.ConclusionsThe survey showed a diversity of treatment pathways. The need to develop a robust, clear pathway for patients with leg ulceration is clearly required.

Journal article

Gohel MS, Heatley F, Liu X, Bradbury A, Bulbulia R, Cullum N, Epstein DM, Nyamekye I, Poskitt KR, Renton S, Warwick J, Davies AHet al., 2019, Early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration: the EVRA RCT, Health Technology Assessment, Vol: 23, Pages: 1-96, ISSN: 1366-5278

BackgroundVenous ulceration is a common and costly health-care issue worldwide, with poor healing rates greatly affecting patient quality of life. Compression bandaging has been shown to improve healing rates and reduce recurrence, but does not address the underlying cause, which is often superficial venous reflux. Surgical correction of the reflux reduces ulcer recurrence; however, the effect of early endovenous ablation of superficial venous reflux on ulcer healing is unclear.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of compression therapy with early endovenous ablation of superficial venous reflux compared with compression therapy with deferred endovenous ablation in patients with venous ulceration.DesignA pragmatic, two-arm, multicentre, parallel-group, open randomised controlled trial with a health economic evaluation.SettingSecondary care vascular centres in England.ParticipantsPatients aged ≥ 18 years with a venous leg ulcer of between 6 weeks’ and 6 months’ duration and an ankle–brachial pressure index of ≥ 0.8 who could tolerate compression and were deemed suitable for endovenous ablation of superficial venous reflux.InterventionsParticipants were randomised 1 : 1 to either early ablation (compression therapy and superficial endovenous ablation within 2 weeks of randomisation) or deferred ablation (compression therapy followed by endovenous ablation once the ulcer had healed).Main outcome measuresThe primary outcome measure was time from randomisation to ulcer healing, confirmed by blinded assessment. Secondary outcomes included 24-week ulcer healing rates, ulcer-free time, clinical success (in addition to quality of life), costs and quality-adjusted life-years (QALYs). All analyses were performed on an intention-to-treat basis.ResultsA total of 450 participants were recruited (224 to early and 226 to deferred superficial endovenous ablation). Baseline characteristics were si

Journal article

Lawton R, Babber A, Braithwaite B, Burgess L, Burgess LJ, Chetter I, Coulston J, Epstein D, Fiorentino F, Gohel M, Heatley F, Hinchliffe R, Horgan S, Pal N, Shalhoub J, Simpson R, Stansby G, Davies Aet al., 2019, A multicenter randomized controlled study to evaluate whether neuromuscular electrical stimulation improves the absolute walking distance in patients with intermittent claudication compared with best available treatment, Journal of Vascular Surgery, Vol: 69, Pages: 1567-1573, ISSN: 0741-5214

Objective:To assess the clinical efficacy of an NMES device to improve the absolute walking distance (AWD) in patients with IC, as an adjunct to the local standard care available at the study sites compared to local standard care alone.Methods:An open, multicentre, randomised controlled trial including eight participating centres in England. Sites are equally distributed between those that provide SET programmes and those that do not. Patients with IC meeting the inclusion and exclusion criteria, and providing consent will be randomised, depending on the centre type, to either NMES and locally available standard care or standard care alone. The primary endpoint, AWD, will be measured at 3 months (the end of the intervention period) by treadmill testing. Secondary outcomes include quality of life assessment, compliance with the interventions, economic evaluation of the NMES device, and lower limb haemodynamic measures to further the understanding of underlying mechanisms. Recruitment is due to commence in February 2018 and will continue for a total of 15 months. The NESIC trial is funded by the UK Efficacy and Mechanism Evaluation (EME) Programme, Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership. ISRCTN 18242823.

Journal article

Epstein DM, Gohel MS, Heatley F, Liu X, Bradbury A, Bulbulia R, Cullum N, Nyamekye I, Poskitt KR, Renton S, Warwick J, Davies AH, Gohel MS, Read D, Hargreaves S, Dhillon K, Anwar M, Liddle A, Brown H, Mercer K, Gill F, Liu A, Jepson W, Wormwell A, Rafferty H, Davies AH, Dhillon K, Kaur R, Solomon E, Sritharan K, Velineni R, Lim CS, Busuttil A, Bootun R, Bicknell C, Jenkins M, Lane T, Serjeant E, Poskitt K, Bulbulia R, Waldron J, Wolfrey G, Slim F, Davies C, Emerson L, Grasty M, Whyman M, Wakeley C, Cooper A, Clapp J, Hogg N, Howard J, Dyer J, Lyes S, Teemul D, Harvey K, Pride M, Kindon A, Price H, Flemming L, Birch G, Holmes H, Weston J, Joseph T, Eiffel R, Ojimba T, Wilson T, Hodgson A, Robinson L, Todhunter J, Heagarty D, Mckeane A, McCarthy R, Barwell J, Northcott C, Elstone A, West C, Chong P, Gerrard D, Croucher A, Levy S, Martin C, Craig T, Carradice D, Firth A, Clarke E, Oswald A, Sinclair J, Chetter I, El-Sheikha J, Nandhra S, Leung C, Scott J, Dewhirst N, Woods J, Russell D, Darwood R, Troxler M, Thackeray J, Bell D, Watson D, Williamson L, Coulston J, Eyers P, Darvall K, Hunter I, Stewart A, Moss A, Rewbury J, Adams C, Vickery L, Foote L, Durman H, Venn F, Hill P, James K, Luxton F, Greenwell D, Roberts K, Mitchell S, Tate M, Mills H, Garnham A, Hobbs S, McIntosh D, Green M, Collins K, Rankin J, Poulton P, Isgar V, Renton S, Dhillon K, Trivedi M, Kafeza M, Parsapour S, Moore H, Najem M, Connarty S, Albon H, Lloyd C, Trant J, Vohra R, McCormack J, Marshall J, Hardy V, Rogoveanu R, Goff W, Garnham A, Gidda R, Merotra S, Shiralkar S, Jayatunga A, Pathak R, Rehman A, Randhawa K, Lewis J, Fullwood S, Jennings S, Cole S, Wall M, Ranaboldo C, Hulin S, Clarke C, Fennelly R, Cooper R, Boyes R, Draper C, Harris L, Mead D, Bradbury A, Kelly L, Bate G, Davies H, Popplewell M, Claridge M, Gannon M, Khaira H, Scriven M, Wilmink T, Adam D, Nasr H, Dodd D, Nawaz S, Humphreys J, Barnes M, Sorrell J, Swift D, Phillips P, Trender H, Fenwick N, Rittoo D, Baker S, Mitchell Ret al., 2019, Cost-effectiveness analysis of a randomized clinical trial of early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration, British Journal of Surgery, Vol: 106, Pages: 555-562, ISSN: 0007-1323

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

Journal article

Epstein D, Gohel MS, Heatley FM, Davies Aet al., 2018, Cost-effectiveness of treatments for superficial venous refluxin patients with chronic venous ulceration., BJS Open, Vol: 2, Pages: 203-212, ISSN: 2474-9842

BackgroundVenous leg ulcers impair quality of life significantly, with substantial costs to health services. The aim of this study was to estimate the cost‐effectiveness of interventional procedures alongside compression therapy versus compression therapy alone for the treatment of chronic venous leg ulceration.MethodsA Markov decision analytical model was developed. The main outcome measures were quality‐adjusted life‐years (QALYs) and lifetime costs per patient, from the perspective of the UK National Health Service at 2015 prices. Resource use included the initial procedures, compression therapy, primary care and outpatient consultations. The interventional procedures included superficial venous surgery, endothermal ablation and ultrasound‐guided foam sclerotherapy (UGFS). The study population was patients with a chronic venous ulcer who were eligible for either compression therapy or an interventional procedure. Data were obtained from systematic review and meta‐analysis of RCTs.ResultsSurgery gained 0·112 (95 per cent c.i. −0·011 to 0·213) QALYs compared with compression therapy alone, with a difference in lifetime costs of €−1330 (−3570 to 1262). Given the expected savings in community care, the procedure would pay for itself within 4 years. There was insufficient evidence regarding endothermal ablation and UGFS to draw conclusions.DiscussionThis modelling study found surgery to be more effective and less costly than compression therapy alone. Further RCT evidence is required for both endothermal ablation and UGFS.

Journal article

Gohel MS, Heatley FM, Epstein D, Warwick J, Liu X, Davies Aet al., 2018, A randomized trial of early endovenous ablation in venous ulceration, New England Journal of Medicine, Vol: 378, Pages: 2105-2114, ISSN: 0028-4793

Background: Venous disease is the most common cause of leg ulceration. Although compression therapy improves venous ulcer healing, it does not treat the underlying causes of venous hypertension. Treatment of superficial venous reflux has been shown to reduce the rate of ulcer recurrence, but the effect of early endovenous ablation of superficial venous reflux on ulcer healing remains unclear.Methods:In a trial conducted at 20 centers in the United Kingdom, we randomly assigned 450 patients with venous leg ulcers to receive compression therapy and undergo early endovenous ablation of superficial venous reflux within 2 weeks after randomization (early-intervention group) or to receive compression therapy alone, with consideration of endovenous ablation deferred until after the ulcer was healed or until 6 months after randomization if the ulcer was unhealed (deferred-intervention group). The primary outcome was the time to ulcer healing. Secondary outcomes were the rate of ulcer healing at 24 weeks, the rate of ulcer recurrence, the length of time free from ulcers (ulcer-free time) during the first year after randomization, and patient-reported health-related quality of life.Results:Patient and clinical characteristics at baseline were similar in the two treatment groups. The time to ulcer healing was shorter in the early-intervention group than in the deferred-intervention group; more patients had healed ulcers with early intervention (hazard ratio for ulcer healing, 1.38; 95% confidence interval [CI], 1.13 to 1.68; P=0.001). The median time to ulcer healing was 56 days (95% CI, 49 to 66) in the early-intervention group and 82 days (95% CI, 69 to 92) in the deferred-intervention group. The rate of ulcer healing at 24 weeks was 85.6% in the early-intervention group and 76.3% in the deferred-intervention group. The median ulcer-free time during the first year after trial enrollment was 306 days (interquartile range, 240 to 328) in the early-intervention group and 278 da

Journal article

Shalhoub J, Norrie J, Baker C, Bradbury AW, Dhillon K, Everington T, Gohel M, Hamady Z, Heatley F, Hudson J, Hunt BJ, Stansby G, Stephens-Boal A, Warwick D, Davies AHet al., 2017, Graduated compression stockings as an adjunct to low dose low molecular weight heparin in venous thromboembolism prevention in surgery– a multi-centre randomised controlled trial, European Journal of Vascular and Endovascular Surgery, Vol: 53, Pages: 880-885, ISSN: 1532-2165

Background:The evidence base upon which current global venous thromboembolism (VTE) prevention recommendations have been made is not optimal. The cost of purchasing and applying Graduated Compression Stockings (GCS) in surgical patients is considerable and has been estimated at £63.1 million each year in England alone.Objective:To determine whether low dose low molecular weight heparin (LMWH) alone is non-inferior to a combination of GCS and low dose LMWH for the prevention of VTE.Methods:A randomised controlled Graduated compression as an Adjunct to Pharmacoprophylaxis in Surgery (GAPS) Trial [ISRCTN 13911492] will randomise adult elective surgical patients identified as being at moderate and high risk for VTE to receive either the current ‘standard’ combined thromboprophylactic LMWH with GCS mechanical thromboprophylaxis, or thromboprophylactic LMWH pharmacoprophylaxis alone. To show non-inferiority (3.5% non-inferiority margin) for the primary endpoint of all VTE within 90 days, 2236 patients are required. Recruitment will be from seven UK centres. Secondary outcomes include quality of life, compliance with stockings and LMWH, overall mortality, and GCS or LMWH-related complications (including bleeding).Recruitment commenced in April 2016 with the seven UK centres coming ‘on-line’ in a staggered fashion. Recruitment will be over a total of 18 months. The GAPS trial is funded by the National Institute for Health Research Health Technology Assessment in the UK [14/140/61].

Journal article

Grieve R, Gomes M, Sweeting MJ, Ulug P, Hinchliffe RJ, Thompson MM, Thompson SG, Ashleigh R, Greenhalgh RM, Powell JT, IMPROVE trial investigatorset al., 2015, Endovascular strategy or open repair for ruptured abdominal aortic aneurysm: one-year outcomes from the IMPROVE randomized trial., European Heart Journal, Vol: 36, Pages: 2061-2069, ISSN: 1522-9645

AIMS: To report the longer term outcomes following either a strategy of endovascular repair first or open repair of ruptured abdominal aortic aneurysm, which are necessary for both patient and clinical decision-making. METHODS AND RESULTS: This pragmatic multicentre (29 UK and 1 Canada) trial randomized 613 patients with a clinical diagnosis of ruptured aneurysm; 316 to an endovascular first strategy (if aortic morphology is suitable, open repair if not) and 297 to open repair. The principal 1-year outcome was mortality; secondary outcomes were re-interventions, hospital discharge, health-related quality-of-life (QoL) (EQ-5D), costs, Quality-Adjusted-Life-Years (QALYs), and cost-effectiveness [incremental net benefit (INB)]. At 1 year, all-cause mortality was 41.1% for the endovascular strategy group and 45.1% for the open repair group, odds ratio 0.85 [95% confidence interval (CI) 0.62, 1.17], P = 0.325, with similar re-intervention rates in each group. The endovascular strategy group and open repair groups had average total hospital stays of 17 and 26 days, respectively, P < 0.001. Patients surviving rupture had higher average EQ-5D utility scores in the endovascular strategy vs. open repair groups, mean differences 0.087 (95% CI 0.017, 0.158), 0.068 (95% CI -0.004, 0.140) at 3 and 12 months, respectively. There were indications that QALYs were higher and costs lower for the endovascular first strategy, combining to give an INB of £3877 (95% CI £253, £7408) or €4356 (95% CI €284, €8323). CONCLUSION: An endovascular first strategy for management of ruptured aneurysms does not offer a survival benefit over 1 year but offers patients faster discharge with better QoL and is cost-effective. CLINICAL TRIAL REGISTRATION: ISRCTN 48334791.

Journal article

Rudarakanchana N, Reeves BC, Bicknell CD, Heatley FM, Cheshire NJ, Powell JTet al., 2014, Editor's Choice - Treatment Decisions for Descending Thoracic Aneurysm: Preferences for Thoracic Endovascular Aneurysm Repair or Surveillance in a Discrete Choice Experiment, EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, Vol: 48, Pages: 13-22, ISSN: 1078-5884

Journal article

Powell JT, Hinchliffe RJ, Thompson MM, Sweeting MJ, Ashleigh R, Bell R, Gomes M, Greenhalgh RM, Grieve RJ, Heatley F, Thompson SG, Ulug Pet al., 2014, An Endovascular Strategy for Suspected Ruptured Abdominal Aortic Aneurysm Brings Earlier Home Discharge but Not Early Survival or Cost Benefits, EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, Vol: 47, Pages: 333-334, ISSN: 1078-5884

Journal article

Powell JT, Hinchliffe RJ, Thompson MM, Sweeting MJ, Ashleigh R, Bell R, Gomes M, Greenhalgh RM, Grieve RJ, Heatley F, Thompson SG, Ulug Pet al., 2014, Observations from the IMPROVE trial concerning the clinical care of patients with ruptured abdominal aortic aneurysm, British Journal of Surgery, Vol: 101, Pages: 216-224, ISSN: 1365-2168

Background: Single-centre series of the management of patients with ruptured abdominal aorticaneurysm (AAA) are usually too small to identify clinical factors that could improve patient outcomes.Methods: IMPROVE is a pragmatic, multicentre randomized clinical trial in which eligible patients witha clinical diagnosis of ruptured aneurysm were allocated to a strategy of endovascular aneurysm repair(EVAR) or to open repair. The influences of time and manner of hospital presentation, fluid volumestatus, type of anaesthesia, type of endovascular repair and time to aneurysm repair on 30-day mortalitywere investigated according to a prespecified plan, for the subgroup of patients with a proven diagnosisof ruptured or symptomatic AAA. Adjustment was made for potential confounding factors.Results: Some 558 of 613 randomized patients had a symptomatic or ruptured aneurysm: diagnosticaccuracy was 91·0 per cent. Patients randomized outside routine working hours had higher operativemortality (adjusted odds ratio (OR) 1·47, 95 per cent confidence interval 1·00 to 2·17). Mortality ratesafter primary and secondary presentation were similar. Lowest systolic blood pressure was stronglyand independently associated with 30-day mortality (51 per cent among those with pressure below 70mmHg). Patients who received EVAR under local anaesthesia alone had greatly reduced 30-day mortalitycompared with those who had general anaesthesia (adjusted OR 0·27, 0·10 to 0·70).Conclusion: These findings suggest that the outcome of ruptured AAA might be improved by wider useof local anaesthesia for EVAR and that a minimum blood pressure of 70 mmHg is too low a thresholdfor permissive hypotension.

Journal article

Powell JT, Sweeting MJ, Thompson MM, Ashleigh R, Bell R, Gomes M, Greenhalgh RM, Grieve R, Heatley F, Hinchliffe RJ, Thompson SG, Ulug Pet al., 2014, Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial, British Medical Journal, Vol: 348, ISSN: 1468-5833

Objective To assess whether a strategy of endovascular repair (if aortic morphology is suitable, open repair if not) versus open repair reduces early mortality for patients with suspected ruptured abdominal aortic aneurysm.Design Randomised controlled trial.Setting 30 vascular centres (29 UK, 1 Canadian), 2009-13.Participants 613 eligible patients (480 men) with a clinical diagnosis of ruptured aneurysm.Interventions 316 patients were randomised to the endovascular strategy (275 confirmed ruptures, 174 anatomically suitable for endovascular repair) and 297 to open repair (261 confirmed ruptures).Main outcome measures 30 day mortality, with 24 hour and in-hospital mortality, costs, and time and place of discharge as secondary outcomes.Results 30 day mortality was 35.4% (112/316) in the endovascular strategy group and 37.4% (111/297) in the open repair group: odds ratio 0.92 (95% confidence interval 0.66 to 1.28; P=0.62); odds ratio after adjustment for age, sex, and Hardman index 0.94 (0.67 to 1.33). Women may benefit more than men (interaction test P=0.02) from the endovascular strategy: odds ratio 0.44 (0.22 to 0.91) versus 1.18 (0.80 to 1.75). 30 day mortality for patients with confirmed rupture was 36.4% (100/275) in the endovascular strategy group and 40.6% (106/261) in the open repair group (P=0.31). More patients in the endovascular strategy than in the open repair group were discharged directly to home (189/201 (94%) v 141/183 (77%); P<0.001). Average 30 day costs were similar between the randomised groups, with an incremental cost saving for the endovascular strategy versus open repair of £1186 (€1420; $1939) (95% confidence interval −£625 to £2997).Conclusions A strategy of endovascular repair was not associated with significant reduction in either 30 day mortality or cost. Longer term cost effectiveness evaluations are needed to assess the full effects of the endovascular strategy in both men and women.

Journal article

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