Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI): Study protocol for a randomized controlled trial

Background: Chronic mesenteric ischemia (CMI) is the result of insufficient blood supply to the gastrointestinal tract and is caused by atherosclerotic stenosis of one or more mesenteric arteries in > 90% of cases. Revascularization therapy is indicated in patients with a diagnosis of atherosclerotic CMI to relieve symptoms and to prevent acute-on-chronic mesenteric ischemia, which is associated with high morbidity and mortality. Endovascular therapy has rapidly evolved and has replaced surgery as the first choice of treatment in CMI. Bare-metal stents (BMS) are standard care currently, although retrospective studies suggested significantly highe

Feasibility and reliability of pain pressure threshold measurements in patellar tendinopathy

Patellar tendinopathy is a common and often difficult to treat overuse injury which is characterized by activity-related anterior knee and focal palpation tenderness of the patellar tendon. The clinical diagnosis is mainly based on clinical examination, in which the yardstick is a non-standardized manual palpation. To standardize this palpation procedure the use of an algometer seems applicable. The purpose of this study was to investigate the feasibility and reliability of the algometer in patellar tendinopathy. A cross sectional study was carried out. The algometer was applied to the patellar tendon in 20 asymptomatic volleyball players to measure the 'normal' pressure pain threshold. The inter-rater reliability was analyzed in 54 athletes with symptomatic patellar tendinopathy, the intra-rater reliability was analyzed in 48 athletes with symptomatic patellar tendinopathy. During the procedure difficulties were described, the SEM, intra class correlations and limits of agreement were determined using the Bland and Altman method. The feasibility of the algometer is adequate. The PPT of asymptomatic athletes differs significantly (

La Real Casa dei Matti di Palermo: storia di un'innovazione terapeutica tra architettura e letteratura

La storia di questa struttura psichiatrica rappresenta uno straordinario esempio di come innovazione medica, letteratura e architettura si intreccino formando un\u2019unica trama storica che merita di essere letta e tenuta in considerazion

The Dutch Central Sensitization Inventory (CSI): factor analysis, discriminative power and test-retest reliability

Objectives: A standardized assessment of central sensitization can be performed with the Central Sensitization Inventory (CSI), an English questionnaire consisting of 25 items relating to current health symptoms. The aim of this study was to translate the CSI into Dutch, to perform a factor analysis to reveal the underlying structure, examine its discriminative power, and test-retest reliability. Methods: The CSI was first translated into Dutch. A factor analysis was conducted on CSI data of a large group of chronic pain patients (n = 368). The ability to discriminate between chronic pain patients (n = 188) and pain-free controls (n = 49) was determined and the test-retest reliability for chronic pain patients (n = 36) and controls (n = 45) with a time interval of 3 weeks was evaluated. Results: The exploratory factor analysis resulted in a 4-factor model based on 20 items, representing the domains "General disability and physical symptoms" (Cronbach alpha = 0.80), "Higher central sensitivity" (Cronbach alpha = 0.78), "Urological and dermatological symptoms"( Cronbach alpha = 0.60), and "Emotional distress"(Cronbach alpha = 0.80). Furthermore, a parsimonious second-order factor model was found, where the factor "General central sensitization" was underlying the 4 first-order factors. Chronic pain patients scored significantly worse on all 4 factors. The test-retest reliability was excellent values in both chronic pain patients (ICC = 0.88) and controls (ICC = 0.91). Discussion: The original CSI was translated into Dutch and did not reveal any problems during data acquisition. The domains represented by the 4 factors may be useful in setting up specific patient profiles and treatment targets. To conclude, the Dutch CSI revealed 4 distinguishable domains, showed good internal consistency for the total score and 3 out of 4 domains, good discriminative power, and excellent test-retest reliability

Covered stents versus Bare-metal stents in c hronic atherosclerotic Gastrointestinal Ischemia (CoBaGI):study protocol for a randomized controlled trial

Background: Chronic mesenteric ischemia (CMI) is the result of insufficient blood supply to the gastrointestinal tract and is caused by atherosclerotic stenosis of one or more mesenteric arteries in > 90% of cases. Revascularization therapy is indicated in patients with a diagnosis of atherosclerotic CMI to relieve symptoms and to prevent acute-on-chronic mesenteric ischemia, which is associated with high morbidity and mortality. Endovascular therapy has rapidly evolved and has replaced surgery as the first choice of treatment in CMI. Bare-metal stents (BMS) are standard care currently, although retrospective studies suggested significantly higher patency rates for covered stents (CS). The Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI) trial is designed to prospectively assess the patency of CS versus BMS in patients with atherosclerotic CMI. Methods/design: The CoBaGI trial is a randomized controlled, parallel-group, patient- and investigator-blinded, superiority, multicenter trial conducted in six centers of the Dutch Mesenteric Ischemia Study group (DMIS). Eighty-four patients with a consensus diagnosis of atherosclerotic CMI are 1:1 randomized to either a balloon-expandable BMS (Palmaz Blue with rapid-exchange delivery system, Cordis Corporation, Bridgewater, NJ, USA) or a balloon-expandable CS (Advanta V12 over-the-wire, Atrium Maquet Getinge Group, Hudson, NH, USA). The primary endpoint is the primary stent-patency rate at 24 months assessed with CT angiography. Secondary endpoints are primary stent patency at 6 and 12 months and secondary patency rates, freedom from restenosis, freedom from symptom recurrence, freedom from re-intervention, quality of life according the EQ-5D-5 L and SF-36 and cost-effectiveness at 6, 12 and 24 months. Discussion: The CoBaGI trial is designed to assess the patency rates of CS versus BMS in patients treated for CMI caused by atherosclerotic mesenteric stenosis. Furthermore, the CoBaGI trial should provide insights in the quality of life of these patients before and after stenting and its cost-effectiveness. The CoBaGI trial is the first randomized controlled trial performed in CMI caused by atherosclerotic mesenteric artery stenosis. Trial registration: ClinicalTrials.gov, ID: NCT02428582. Registered on 29 April 2015