Cooled radiofrequency ablation versus cryoneurolysis of the genicular nerves for the symptomatic pain management in knee osteoarthritis: a study protocol of a prospective, randomized, single-blinded clinical trial.

BACKGROUND: Cooled radiofrequency ablation (CRFA) and cryoneurolysis (CRYO) are two novel methods of genicular neurolysis to relief pain in symptomatic knee osteoarthritis (KOA). In this study, the two methods will be compared, giving us the opportunity to investigate their efficacy, safety and complications. METHODS: In this prospective randomized trial 70 patients with KOA will be recruited using a diagnostic block of four genicular nerves. Two groups will be created through software randomization: a CRFA group (35 patients) and a CRYO group (35 patients). The target of the interventions will be four genicular nerves; the superior medial, superior lateral, inferior medial, as well as the medial (retinacular) genicular branch from vastus intermedius. The primary outcome of this clinical trial will be the efficacy of CRFA or CRYO at 2-, 4-, 12-and 24-weeks post-intervention using the Numerical Rating Pain Scale (NRPS). The secondary outcomes are the safety of the two techniques, as well as the clinical evaluation using the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Oxford Knee Score (OKS), and the 7-point scale of Patient Global Impression of Change (PGIC). DISCUSSION: These two novel techniques can block pain transmission through genicular nerves in different ways. In contrast to cryoneurolysis, the CRFA method has been well documented in the past. This is the first clinical trial to compare CRFA vs CRYO and draw conclusions about their safety and efficacy. TRIAL REGISTRATION: ISRCTN87455770 [ https://doi.org/10.1186/ISRCTN87455770 ]. Registered 29/3/2022, first patient recruited 31/8/2022.

The Pathogenesis of Extraintestinal Manifestations: Implications for IBD Research, Diagnosis, and Therapy.

This article reports on the sixth scientific workshop of the European Crohn's and Colitis Organisation [ECCO] on the pathogenesis of extraintestinal manifestations [EIMs] in inflammatory bowel disease [IBD]. This paper has been drafted by 15 ECCO members and 6 external experts [in rheumatology, dermatology, ophthalmology, and immunology] from 10 European countries and the USA. Within the workshop, contributors formed subgroups to address specific areas. Following a comprehensive literature search, the supporting text was finalized under the leadership of the heads of the working groups before being integrated by the group consensus leaders.

Inflammatory Bowel Disease [IBD] and Physical Activity: A Study on the Impact of Diagnosis on the Level of Exercise Amongst Patients With IBD.

BACKGROUND AND AIMS: Inflammatory bowel disease [IBD] can impair patients' functional capacity with significant negative effects on their quality of life. Our aim was to determine the impact of IBD diagnosis on fitness levels and to assess the levels of engagement in physical activity and fatigue in IBD patient before and after diagnosis. METHODS: A prospective multi-centre cross-sectional study was performed. Patients diagnosed with IBD in the previous 18 months were recruited. Inclusion criteria included clinical remission and/or no treatment changes within the previous 6 months. Physical exercise levels were assessed by the Godin score and fatigue levels was assessed by the functional assessment of chronic illness therapy [FACIT] score. RESULTS: In total, 158 patients (100 Crohn's disease [CD]) were recruited. Mean age was 35.1 years (95% confidence interval [CI] ± 2.0). Gender distribution was approximately equal [51.3% male]. The Mean Harvey Bradshaw and Simple Clinical Colitis Activity indices were 2.25 [95% CI ± 0.40] and 1.64 [95% CI ± 0.49], respectively. The mean Godin score difference before and after IBD diagnosis was 6.94 [p = 0.002]. Patients with ulcerative colitis [UC] [41.8%] were more likely than patients with CD [23.0%] to reduce their exercise levels [p = 0.04]. FACIT scores were lower in patients who had experienced relapses [p = 0.012] and had severe disease [p = 0.011]. Approximately one-third of patients reduced their activity level following IBD diagnosis. CONCLUSIONS: Patients were significantly less physically active after a diagnosis of IBD and this was more apparent in UC. Identification of the risk factors associated with loss of fitness levels would help to address the reduced patient quality of life.

Systematic review with meta-analysis: proximal disease extension in limited ulcerative colitis.

BACKGROUND: Disease extent in ulcerative colitis is one of the major factors determining prognosis over the long-term. Disease extent is dynamic and a proportion of patients presenting with limited disease progress to more extensive forms of disease over time. AIM: To perform a systematic review and meta-analysis of epidemiological studies reporting on extension of ulcerative colitis to determine frequency of disease extension in patients with limited ulcerative colitis at diagnosis. METHODS: We performed a systematic literature search to identify studies on disease extension of ulcerative colitis (UC) and predictors of disease progression. RESULTS: Overall, 41 studies were eligible for systematic review but only 30 for meta-analysis. The overall pooled frequency of UC extension was 22.8% with colonic extension being 17.8% at 5 years and 31% at 10 years. Extension was 17.8% (95% CI 11.2-27.3) from E1 to E3, 27.5% (95% CI 7.6-45.6) from E2 to E3 and 20.8% (95% CI 11.4-26.8) from E1 to E2. Rate of extension was significantly higher in patients younger than 18 years (29.2% (CI 6.4-71.3) compared to older patients (20.2% (CI 13.0-30.1) (P<.0001). Risk of extension was significantly higher in patients from North America (37.8%) than from Europe (19.6%) (P<.0001). CONCLUSIONS: In this meta-analysis, approximately one quarter of patients with limited UC extend over time with most extension occurring during the first 10 years. Rate of extension depends on age at diagnosis and geographic origin. Predicting those at high risk of disease extension from diagnosis could lead to personalised therapeutic strategies.

FD-OCT and IVUS intravascular imaging modalities in peripheral vasculature.

INTRODUCTION: Intra-Vascular Ultra-Sound (IVUS) and Frequency Domain-Optical Coherence Tomography (FD-OCT), in vivo, intra-vascular, imaging modalities, widely used in the field of coronary disease, have been recently implemented in peripheral endovascular procedures, for procedural assessment, plaque characterization and determination of predictors of treatment outcomes. Their unique characteristics have also been used in order to provide additional features and improve the performance of re-entry devices and atherotomes. Areas covered: Present review focuses on available literature regarding these two promising imaging technologies in the peripheral vasculature, highlighting the added value produced by their use in endovascular therapy, their limitations and their utilization in new endovascular devices. Authors also provide their future perspective and the possible benefits in understanding vascular behavior and lesion characterization in peripheral endovascular interventions. Expert commentary: By providing both quantitative but also qualitative data on vessel and lesion morphology, intravascular imaging modalities offer a valid solution for endovascular treatment evaluation and outcome presentation homogeneity.

Diagnosis of Aortic Graft Infection: A Case Definition by the Management of Aortic Graft Infection Collaboration (MAGIC).

OBJECTIVE/BACKGROUND: The management of aortic graft infection (AGI) is highly complex and in the absence of a universally accepted case definition and evidence-based guidelines, clinical approaches and outcomes vary widely. The objective was to define precise criteria for diagnosing AGI. METHODS: A process of expert review and consensus, involving formal collaboration between vascular surgeons, infection specialists, and radiologists from several English National Health Service hospital Trusts with large vascular services (Management of Aortic Graft Infection Collaboration [MAGIC]), produced the definition. RESULTS: Diagnostic criteria from three categories were classified as major or minor. It is proposed that AGI should be suspected if a single major criterion or two or more minor criteria from different categories are present. AGI is diagnosed if there is one major plus any criterion (major or minor) from another category. (i) Clinical/surgical major criteria comprise intraoperative identification of pus around a graft and situations where direct communication between the prosthesis and a nonsterile site exists, including fistulae, exposed grafts in open wounds, and deployment of an endovascular stent-graft into an infected field (e.g., mycotic aneurysm); minor criteria are localized AGI features or fever ≥38°C, where AGI is the most likely cause. (ii) Radiological major criteria comprise increasing perigraft gas volume on serial computed tomography (CT) imaging or perigraft gas or fluid (≥7 weeks and ≥3 months, respectively) postimplantation; minor criteria include other CT features or evidence from alternative imaging techniques. (iii) Laboratory major criteria comprise isolation of microorganisms from percutaneous aspirates of perigraft fluid, explanted grafts, and other intraoperative specimens; minor criteria are positive blood cultures or elevated inflammatory indices with no alternative source. CONCLUSION: This AGI definition potentially offers a practical and consistent diagnostic standard, essential for comparing clinical management strategies, trial design, and developing evidence-based guidelines. It requires validation that is planned in a multicenter, clinical service database supported by the Vascular Society of Great Britain & Ireland.

Comparison of angioplasty and bypass surgery for critical limb ischaemia in patients with infrapopliteal peripheral artery disease.

BACKGROUND: Both infrapopliteal (IP) bypass surgery and percutaneous transluminal angioplasty have been shown to be effective in patients with critical limb ischaemia (CLI). The most appropriate method of revascularization has yet to be established, as no randomized trials have been reported. The aim of this study was to compare the outcomes of patients with similar characteristics treated using either revascularization method. METHODS: Consecutive patients undergoing IP bypass and IP angioplasty for CLI (Rutherford 4-6) at a single institution were compared following propensity score matching. The study endpoints were primary, assisted primary and secondary patency, and amputation-free survival at 12 months, calculated by Kaplan-Meier analysis. RESULTS: Some 279 limbs in 243 patients were included in the study. The two groups differed significantly with respect to the incidence of diabetes (P = 0·024), estimated glomerular filtration rate (P = 0·006), total lesion length (P < 0·001) and Rutherford classification (P = 0·008). These factors were used to construct the propensity score model, which yielded a matched cohort of 125 legs in each group. Primary patency (54·4 versus 51·4 per cent; P = 0·014), assisted primary patency (77·5 versus 62·7 per cent; P = 0·003), secondary patency (84·4 versus 65·8 per cent; P < 0·001) and amputation-free survival (78·7 versus 74·1 per cent; P = 0·043) were significantly better after bypass than angioplasty. However, limb salvage was similar (90·4 versus 94·2 per cent; P = 0·161), and overall complications (36·0 versus 21·6 per cent; P = 0·041) as well as length of hospital stay (18(4-134) versus 5(0-110); P = 0·001) were worse in the surgical bypass group. CONCLUSION: There was no difference in limb salvage rates, but patency and amputation-free survival rates were better 1 year after bypass surgery.

Mouth cancer in inflammatory bowel diseases.

Mouth cancer is a major health problem. Multiple risk factors for developing mouth cancer have been studied and include history of tobacco and alcohol abuse, age over 40, exposure to ultraviolet radiation, human papilloma virus infection (HPV), nutritional deficiencies, chronic irritation, and existence or oral potentially malignant lesions such as leukoplakia and lichen planus. An important risk factor for mouth cancer is chronic immunosuppression and has been extensively reported after solid organ transplantation as well as HIV-infected patients. Diagnosis of inflammatory bowel disease (IBD) is not yet considered as a risk factor for oral cancer development. However, a significant number of patients with IBD are receiving immunosuppressants and biological therapies which could represent potential oral oncogenic factors either by direct oncogenic effect or by continuous immunosuppression favoring carcinogenesis, especially in patients with HPV(+) IBD. Education on modifiable risk behaviors in patients with IBD is the cornerstone of prevention of mouth cancer. Oral screening should be performed for all patients with IBD, especially those who are about to start an immunosuppressant or a biologic.

Vascular manifestations of syndromic aortopathies: role of current and emerging imaging techniques.

Patients with connective tissue diseases such as Marfan's syndrome, Loeys-Dietz syndrome, and vascular Ehlers-Danlos syndrome comprise a small but important group of patients who present early with acute aortic syndrome comprising aneurysmal dilation, rupture, or aortic dissection. Cardiovascular pathologies are an important yet treatable cause of morbidity and mortality in these patients. Imaging plays an important role in initial diagnosis, surveillance, and identification of complications. Furthermore, these patients are prone to developing complications in other vascular territories. Effective screening and surveillance will allow early diagnosis and elective treatment thus reducing the morbidity and mortality associated with presentation with acute complications. In this article, we will provide an overview of the role of magnetic resonance and computed tomography angiography in the management of syndromic aortopathies.

Atherosclerotic Plaque Analysis: A Pilot Study to Assess a Novel Tool to Predict Outcome Following Lower Limb Endovascular Intervention.

INTRODUCTION: Atherosclerotic plaque analysis using computed tomography angiography (CTA) has been found to be accurate and reproducible in the coronary and carotid arteries. The aim of our study was to assess the utility of this technique in predicting outcome following lower limb endovascular interventions. METHODS: Pre-procedural CTA was retrospectively analysed in 50 patients who had undergone femoropopliteal (F-P) angioplasty (and/or stenting). Plaque analysis was performed using TeraRecon workstation by two observers blinded to the long-term outcome. Using the Hounsfield units (HU) scale atherosclerotic plaque composition was subdivided into volumes of soft (-100-100 HU) fibrocalcific (101-300 HU) or calcified (300-1000 HU) components. The relationship between plaque composition, clinical and procedural variables, and the study end points (vessel patency, binary restenosis rate, and Amputation-Free Survival [AFS]) were assessed using multivariate analysis. RESULTS: The technical success rate of the endovascular procedure was 98%, with 48% of patients receiving F-P stents. The AFS was 90%, primary patency 84%, assisted primary patency 88%, and binary restenosis 44% all at 1 year. A significantly greater total volume of calcified plaque (1.1 [.01-3.2] cm(3) vs. .11 [0-1.86] cm(3), p < .001) was found in patients developing restenosis (>50%) compared with those who did not. Patients with a calcified plaque volume greater than 1.1 cm(3) had a significantly worse AFS than those with a volume less than 1.1 cm(3) (p = .0038). Multivariate analysis showed that the percentage calcified plaque (p = .003, HR 11.4, 95% CI 1.45-37.29) was an independent predictor of binary restenosis at 12 months, and that absolute volume of calcified plaque (p = .001, HR 3.56, 95% CI 1.64-7.7) was independently associated with AFS. CONCLUSIONS: The burden of calcified plaque, but not soft or fibrocalcific plaque is related to restenosis, reintervention, and AFS. Computed tomography plaque analysis may form an important non-invasive tool for risk stratification in patients undergoing F-P endovascular procedures.

Treatment Steps, Surgery, and Hospitalization Rates During the First Year of Follow-up in Patients with Inflammatory Bowel Diseases from the 2011 ECCO-Epicom Inception Cohort.

BACKGROUND AND AIMS: The ECCO-EpiCom study investigates the differences in the incidence and therapeutic management of inflammatory bowel diseases [IBD] between Eastern and Western Europe. The aim of this study was to analyse the differences in the disease phenotype, medical therapy, surgery, and hospitalization rates in the ECCO-EpiCom 2011 inception cohort during the first year after diagnosis. METHODS: Nine Western, five Eastern European centres and one Australian centre with 258 Crohn's disease [CD], 380 ulcerative colitis [UC] and 71 IBD unclassified [IBDU] patients [female/male: 326/383; mean age at diagnosis: 40.9 years, SD: 17.3 years] participated. Patients' data were registered and entered in the web-based ECCO-EpiCom database [www.epicom-ecco.eu]. RESULTS: In CD, 36 [19%] Western Europe/Australian and 6 [9%] Eastern European patients received biological therapy [p = 0.04], but the immunosuppressive [IS] use was equal and high in these regions [Eastern Europe vs Western Europe/Australia: 53% vs 45%; p = 0.27]. Surgery was performed in 17 [24%] CD patients in Eastern Europe and 13 [7%] in Western Europe/Australia [p < 0.001, pLogRank = 0.001]. Of CD patients from Eastern Europe, 24 [34%] were hospitalized, and 39 [21%] from Western Europe/Australia, [p = 0.02, pLogRank = 0.01]. In UC, exposure to biologicals and colectomy rates were low and hospitalization rates did not differ between these regions during the 1-year follow-up period [16% vs 16%; p = 0.93]. CONCLUSIONS: During the first year after diagnosis, surgery and hospitalization rates were significantly higher in CD patients in Eastern Europe compared with Western Europe/Australia, whereas significantly more CD patients were treated with biologicals in the Western Europe/Australian centres.

Review article: non-malignant oral manifestations in inflammatory bowel diseases.

BACKGROUND: Patients with inflammatory bowel diseases (IBD) may present with lesions in their oral cavity. Lesions may be associated with the disease itself representing an extraintestinal manifestation, with nutritional deficiencies or with complications from therapy. AIM: To review and describe the spectrum of oral nonmalignant manifestations in patients with inflammatory bowel diseases [ulcerative colitis (UC), Crohn's disease (CD)] and to critically review all relevant data. METHODS: A literature search using the terms and variants of all nonmalignant oral manifestations of inflammatory bowel diseases (UC, CD) was performed in November 2014 within Pubmed, Embase and Scopus and restricted to human studies. RESULTS: Oral lesions in IBD can be divided into three categories: (i) lesions highly specific for IBD, (ii) lesions highly suspicious of IBD and (iii) nonspecific lesions. Oral lesions are more common in CD compared to UC, and more prevalent in children. In adult CD patients, the prevalence rate of oral lesions is higher in CD patients with proximal gastrointestinal tract and/or perianal involvement, and estimated to range between 20% and 50%. Oral lesions can also occur in UC, with aphthous ulcers being the most frequent type. Oral manifestations in paediatric UC may be present in up to one-third of patients and are usually nonspecific. CONCLUSIONS: Oral manifestations in IBD can be a diagnostic challenge. Treatment generally involves managing the underlying intestinal disease. In cases presenting with local disabling symptoms and impaired quality of life, local and systemic medical therapy must be considered and/or oral surgery may be required.

The second European evidenced-based consensus on reproduction and pregnancy in inflammatory bowel disease.

Trying to conceive and being pregnant is an emotional period for those involved. In the majority of patients suffering from inflammatory bowel disease, maintenance therapy is required during pregnancy to control the disease, and disease control might necessitate introduction of new drugs during a vulnerable period. In this updated consensus on the reproduction and pregnancy in inflammatory bowel disease reproductive issues including fertility, the safety of drugs during pregnancy and lactation are discussed.

Incidence and initial disease course of inflammatory bowel diseases in 2011 in Europe and Australia: results of the 2011 ECCO-EpiCom inception cohort.

BACKGROUND AND AIMS: The aim of the present study was to validate the IBD (inflammatory bowel diseases) incidence reported in the 2010 ECCO-EpiCom (European Crohn's and Colitis Organization-Epidemiological Committee) inception cohort by including a second independent inception cohort from participating centers in 2011 and an Australian center to investigate whether there is a difference in the incidence of IBD between Eastern and Western European countries and Australia. METHODS: Fourteen centers from 5 Eastern and 9 Western European countries and one center from Australia participated in the ECCO-EpiCom 2011 inception cohort. Patients' data regarding disease type, socio-demographic factors, extraintestinal manifestations and therapy were entered into the Web-based EpiCom database, www.ecco-epicom.eu. RESULTS: A total of 711 adult patients were diagnosed during the inclusion year 2011, 178 (25%) from Eastern, 461 (65%) from Western Europe and 72 (10%) from Australia; 259 (37%) patients were diagnosed with Crohn's disease, 380 (53%) with ulcerative colitis and 72 (10%) with IBD unclassified. The mean annual incidence rate for IBD was 11.3/100,000 in Eastern Europe, 14.0/100,000 in Western Europe and 30.3/100,000 in Australia. Significantly more patients were diagnosed with complicated disease at diagnosis in Eastern Europe compared to Western Europe (43% vs. 27%, p=0.02). CONCLUSION: Incidence rates, disease phenotype and initial treatment characteristics in the 2011 ECCO-EpiCom cohort were not significantly different from that reported in the 2010 cohort.

Atherectomy of the femoropopliteal artery: a systematic review and meta-analysis of randomized controlled trials.

A systematic review was performed to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing debulking atherectomy versus balloon angioplasty for treatment of femoropopliteal artery occlusive disease. PubMed (MEDLINE), EMBASE, AMED, Scopus, online content and meeting abstracts were searched in May 2014 for eligible RCTs following the PRISMA selection process. Risk of bias was assessed using the Cochrane Collaboration's tool. Pooled risks were calculated with a random effects model to account for clinical and conceptual heterogeneity. Sensitivity analysis was employed to test the robustness of the results. Six RCTs comprising 287 patients (328 lesions) treated with either debulking atherectomy or balloon angioplasty for femoropopliteal artery disease were analyzed and synthesized. Technical success was similar between the atherectomy and the angioplasty group (93.6% vs. 96.2%, RR: 0.99. 95%CI: 0.95-1.03, P=0.57, I(2)=0%). Need for bail-out stenting and distal arterial embolization were largely similar between atherectomy and balloon angioplasty alone. After a median follow-up of 9 months the 2 groups showed similar primary patency (RR: 0.90, 95%CI: 0.56-1.46, P=0.68, I(2)=69%). Only 2 low-quality studies reported amputation and mortality rates, both of which were found significantly less in the atherectomy arms. Analysis of a limited body of low quality evidence with high risk of bias showed that debulking atherectomy of the femoropopliteal artery does not seem to confer any procedural advantage or improvement of clinical outcomes over balloon angioplasty alone.

Paclitaxel-coated balloons for failing peripheral bypass grafts: the BYPACS study.

AIM: Aim of the present study was to report the imaging and clinical outcomes of a prospective single-center study investigating paclitaxel-coated balloons (PCB) for the treatment of failing peripheral bypass grafts (BYPACS study). METHODS: In total, 32 patients had their failing peripheral native or synthetic bypass graft treated with PCB angioplasty (Group PCB). Basic inclusion criteria were any significant proximal or distal anastomotic stenosis confirmed by Duplex ultrasound (DUS; PSVR>2.5) associated with significantly reduced in-graft velocities (<45 cm/s) putting the graft at risk of thrombosis. Results were compared with a similar historical control group of 24 patients who had their failing peripheral bypass treated with plain uncoated balloon angioplasty (Group PTA). Primary endpoint was binary lesion restenosis defined as >50% stenosis of the treated lesion on DUS. Secondary endpoints included freedom from target lesion revascularization (TLR) defined as a patent peripheral bypass graft regardless of restenosis but without any repeat intervention (driven by reduced in-graft velocities <45 cm/s), major amputations and graft thrombosis. Multivariable Cox proportional hazards regression analysis was applied to adjust for confounding factors of heterogeneity. Results are reported as Cox-adjusted hazard ratios (HR and 95% CI). RESULTS: Baseline variables were equally distributed between the two groups. Median follow-up was 7 months in group PCB and 8 months in group PTA. Rates of binary restenosis were similar between the 2 groups (HR=1.08, 95% CI=0.49-2.40; P=0.84). Freedom from TLR was also similar (HR=0.97, 95% CI=0.36-2.66; P=0.88). One amputation occurred in the PCB group and 2 in the PTA (P=0.58). Four events of bypass thrombosis occurred in each group (P=0.71). CONCLUSION: PCB does not significantly inhibit restenosis or improve freedom from repeat angioplasty after treatment of failing peripheral arterial vein or synthetic bypass grafts.

Health-related quality of life improves during one year of medical and surgical treatment in a European population-based inception cohort of patients with inflammatory bowel disease--an ECCO-EpiCom study.

BACKGROUND & AIMS: Health-related quality of life (HRQoL) is impaired in patients with Inflammatory Bowel Disease (IBD). The aim was prospectively to assess and validate the pattern of HRQoL in an unselected, population-based inception cohort of IBD patients from Eastern and Western Europe. METHODS: The EpiCom inception cohort consists of 1560 IBD patients from 31 European centres covering a background population of approximately 10.1 million. Patients answered the disease specific Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and generic Short Form 12 (SF-12) questionnaire at diagnosis and after one year of follow-up. RESULTS: In total, 1079 patients were included in this study. Crohn's disease (CD) patients mean SIBDQ scores improved from 45.3 to 55.3 in Eastern Europe and from 44.9 to 53.6 in Western Europe. SIBDQ scores for ulcerative colitis (UC) patients improved from 44.9 to 57.4 and from 48.8 to 55.7, respectively. UC patients needing surgery or biologicals had lower SIBDQ scores before and after compared to the rest, while biological therapy improved SIBDQ scores in CD. CD and UC patients in both regions improved all SF-12 scores. Only Eastern European UC patients achieved SF-12 summary scores equal to or above the normal population. CONCLUSION: Medical and surgical treatment improved HRQoL during the first year of disease. The majority of IBD patients in both Eastern and Western Europe reported a positive perception of disease-specific but not generic HRQoL. Biological therapy improved HRQoL in CD patients, while UC patients in need of surgery or biological therapy experienced lower perceptions of HRQoL than the rest.

Systematic review and meta-analysis of thermal ablation versus surgical nephrectomy for small renal tumours.

PURPOSE: A systematic review was undertaken to provide a meta-analysis of clinical trials comparing thermal ablation with surgical nephrectomy for small renal tumours. METHODS: PubMed (MEDLINE), EMBASE, AMED, and Scopus were searched in August 2013 for eligible prospective or retrospective comparative trials following the PRISMA selection process. Thermal ablation was compared with surgical nephrectomy. Quality of included studies was assessed on the Newcastle-Ottawa Scale (NOS). The primary endpoint was disease-free survival and was analyzed on the log-hazard scale. Secondary outcome measures included complications, local recurrence, and decline of renal function. Hazard ratios (HR) and risk ratios (RR) were calculated with a random effects model, and meta-regression analysis was performed to explore clinical heterogeneity. RESULTS: Six clinical trials (1 randomized and 5 cohort; 6-8 stars on the NOS scale) involving 587 patients with small renal tumors (mean size 2.5 cm) treated with either thermal ablation (percutaneous or laparoscopic application of radiofrequency or microwave) or surgical nephrectomy (open or laparoscopic) were analyzed. Overall complication rate was significantly lower in the ablation group (7.4 vs. 11%; RR: 0.55, 95% confidence interval [CI]: 0.31-0.97, p = 0.04). Postoperative decline of eGFR was higher in case of nephrectomy (mean difference: -14.6 ml/min/1.73 m(2), 95% CI: -27.96 to -1.23, p = 0.03). Local recurrence rate was the same in both groups (3.6 vs. 3.6%; RR: 0.92, 95% CI: 0.4-2.14, p = 0.79) and disease-free survival also was similar up to 5 years (HR: 1.04, 95% CI: 0.48-2.24, p = 0.92). CONCLUSIONS: Thermal ablation of small renal masses produces oncologic outcomes similar to surgical nephrectomy and is associated with significantly lower overall complication rates and a significantly less decline of renal function. More randomized, controlled trials are necessary.

Health care and patients' education in a European inflammatory bowel disease inception cohort: an ECCO-EpiCom study.

BACKGROUND AND AIMS: The EpiCom study and inception cohort was initiated in 2010 in 31 centers from 14 Western and 8 Eastern European countries, covering a 10.1million person background population. Our aim was to investigate whether there is a difference between Eastern and Western Europe in health care and education of patients with inflammatory bowel disease (IBD). METHODS: A quality of care (QoC) questionnaire was developed in the EpiCom group consisting of 16 questions covering 5 items: time interval between the onset of symptoms and diagnosis, information, education, empathy and access to health care providers. RESULTS: Of 1,515 patients, 947 (217 east/730 west) answered the QoC questionnaire. Only 23% of all patients had knowledge about IBD before diagnosis. In Eastern Europe, significantly more patients searched out information about IBD themselves (77% vs. 68%, p<0.05), the main source was the Internet (92% vs. 88% p=0.23). In Western Europe, significantly more patients were educated by nurses (19% vs. 1%, p<0.05), while in Eastern Europe, gastroenterologists were easier to contact (80% vs. 68%, p<0.05). CONCLUSION: Health care differed significantly between Eastern and Western Europe in all items, but satisfaction rates were high in both geographic regions. Because of the low awareness and the rising incidence of IBD, general information should be the focus of patient organizations and medical societies. In Western Europe IBD nurses play a very important role in reducing the burden of patient management.