Outpatient Holmium laser fulguration: A safe procedure for treatment of recurrence of nonmuscle invasive bladder cancer. / Fulguración ambulatoria con láser Holmium: Un procedimiento seguro para el tratamiento de la recidiva del carcinoma vesical no músculo infiltrante.

BACKGROUND AND OBJECTIVE: Nonmuscle invasive bladder cancer has a high recurrence rate and a low progression rate. The aim of this study was to assess the effectiveness, safety and feasibility of Holmium laser fulguration in an outpatient regimen for selected tumours. MATERIAL AND METHOD: A prospective, longitudinal cohort study was conducted between January 2009 and December 2016. Seventy-nine Holmium laser fulguration procedures with subsequent instillation of mitomycin C were performed in an outpatient regimen on 59 patients with a history of low-risk bladder cancer and recurrence of small papillary tumours. We performed a descriptive data analysis and analysed the relapse-free time using Kaplan-Meier curves. RESULTS: All procedures were completed in one day, and only one patient required subsequent hospitalisation due to haematuria. Some 87.2% of the patients presented pain with a visual analogue score ≤3. Recurrence occurred after 49.4% of the procedures (27.3% at 12 months). The median follow-up time was 17 months (range, 2-65). The onset of recurrence was significantly earlier after the second fulguration than after the first (median, 10 months vs. 56 months). CONCLUSIONS: Holmium laser fulguration and subsequent mitomycin C instillation in an outpatient regimen is a safe and feasible alternative to transurethral resection of bladder tumours in selected patients. Transurethral resection of the bladder tumour is recommended for patients with recurrence after fulguration, given the possibly higher risk of progression in these patients.

Long-term follow-up of the AdVance®/AdVanceXP® sling. What are the surgeons' impressions? What are the patients'? / Seguimiento a largo plazo del cabestrillo AdVance®/AdVanceXP®. ¿Qué piensa el cirujano?, ¿qué piensa el paciente?

OBJECTIVES: To analyse the safety, efficacy and quality of life of patients with male stress urinary incontinence after radical prostatectomy treated with the AdVance® and AdvanceXP® slings. PATIENTS AND METHOD: The study included 92 patients with stress urinary incontinence after radical prostatectomy treated with the AdVance® and AdVanceXP® sling between May 2008 and December 2015. A perineal repositioning test was performed in all cases with sphincter coaptation of≥1.5cm. Mild stress urinary incontinence was defined as the use of 1-2 absorbers/24h; moderate was defined as 3-5 absorbers/24h; and severe was defined as more than 5 absorbers/24h. Healing was defined as the total absence of using pads; improvement was defined as a reduction>50% in the number of pads; and failure was defined as a reduction<50, no improvement or worsened incontinence. Check-ups were conducted at 3, 12 and 36 months after the surgery. We employed the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) for the quality of life index. The complications are listed according to the Clavien-Dindo classification. RESULTS: The degree of preoperative incontinence was mild in 23.9%, moderate in 67.4% and severe in 8.7% of the patients. The mean use of preoperative pads was 3.1 (range 1-6, 95% CI). The mean preoperative ICIQ-SF score was 16.5 (15-20). Sphincter coaptation≥1.5cm using the perineal repositioning test was present in 87 patients (94.6%). The mean follow-up from insertion of the sling was 42.1 months. Some 89.1% of the patients were healed at 3 months, 70.7% were healed at 12 months, and 70.4% were healed at 36 months. The ICIQ-SF score at 3, 12 and 36 months showed significant improvement (P<.001) compared with the preoperative score. CONCLUSIONS: The Advance® and AdvanceXP® system are effective over time in terms of urinary continence and patient satisfaction.

[Low and intermediate risk prostate cancer: Treatment options]. / Cáncer de próstata de bajo riesgo e intermedio: opciones de tratamiento.

Patients with low and intermediate risk prostate cancer are the most frequently diagnosed group currently. In those with a life expectancy inferior to 10 years it is highly likely that treatment is not necessary so that observation must be the most appropriate approach. In patients in whom active therapy, in any of its forms, is indicated, it is necessary to balance between risk of dying or developing metastases from the disease and adverse effects of commonly accepted radical treatments, such as radical prostatectomy and external beam or interstitial radiotherapy. The significant incidence of associated morbidity, mainly erectile dysfunction and urinary incontinence, with high impact on quality of life, demands this approach in the field of decisions shared with patients. The risk of overtreatment in this group of patients has generated the introduction of more conservative approaches such as active surveillance and focal therapy. The first one tries to differ radical treatments as far as there are not enough aggressiveness criteria on the tumor or the patient requests them. The second, called to have a place between active surveillance and radical treatments, involves the performance of a partial ablation of the prostate to avoid the adverse effects of radical treatments, trying to achieve the closest oncological control to the radical options. We perform a review of the therapeutic options and their results in this type of patients.

Does the COPD assessment test (CAT(TM)) questionnaire produce similar results when self- or interviewer administered?

PURPOSE: The COPD assessment test (CAT) is a questionnaire that assesses the impact of chronic obstructive pulmonary disease (COPD) on health status, but some patients have difficulties filling it up by themselves. We examined whether the mode of administration of the Spanish version of CAT (self vs. interviewer) influences its scores and/or psychometric properties. METHODS: Observational, prospective study in 49 Spanish centers that includes clinically stable COPD patients (n = 153) and patients hospitalized because of an exacerbation (ECOPD; n = 224). The CAT was self-administered (CAT-SA) or administered by an interviewer (CAT-IA) based on the investigator judgment of the patient's capacity. To assess convergent validity, the Saint George's Respiratory Disease Questionnaire (SGRQ) and the London Chest Activity of Daily Living (LCADL) instrument were also administered. Psychometric properties were compared across modes of administration. RESULTS: A total of 118 patients (31 %) completed the CAT-SA and 259 (69 %) CAT-IA. Multiple regression analysis showed that mode of administration did not affect CAT scores. The CAT showed excellent psychometric properties in both modes of administration. Internal consistency coefficients (Cronbach's alpha) were high (0.86 for CAT-SA and 0.85 for CAT-IA) as was test-retest reliability (intraclass correlation coefficients of 0.83 for CAT-SA and CAT-IA). Correlations with SGRQ and LCADL were moderate to strong both in CAT-SA and CAT-IA, indicating good convergent validity. Similar results were observed when testing longitudinal validity. CONCLUSIONS: The mode of administration does not influence CAT scores or its psychometric properties. Hence, both modes of administration can be used in clinical practice depending on the physician judgment of patient's capacity.

Multicentre trials review process by research ethics committees in Spain: where do they stand before implementing the new European regulation?

OBJECTIVES: To review the performance of research ethics committees (RECs) in Spain in assessing multicentre clinical trial (MCT) drug protocols, and to evaluate if they would comply with the requirements of the new EU Directive to be implemented by May 2004. DESIGN AND SETTING: Prospective study of applications of MCT submitted to RECs. MAIN MEASUREMENTS: Protocol related features and evaluation process dynamics. RESULTS: 187 applications (24 protocols, 18 study drugs) to be performed in 114 centres, were reviewed by 62 RECs. RECs had a median number of 14 members, of which three were lay members. All applications were approved except four which were however approved by the other RECs involved. The median times from submission to approval and from submission to reception at the sponsor's offices were 48 and 62 days, respectively. In 55% (101/183) of all applications approved, 41 RECs raised 307 queries, 40% of these were protocol related issues, and 38% related to the patients' information sheets. RECs charging an evaluation fee in advance and applications with no queries raised were statistically significantly associated with shorter evaluation times. However, there is a gap of at least 1.5 weeks between the date of the meeting and the reception of the approval letter in the sponsor's office. CONCLUSIONS: Evaluating MCT protocols by RECs is a time consuming process. Needing 1.5 weeks for communicating the decision taken by RECs to the sponsor suggests serious administrative shortcomings within most RECs. By significantly reducing the time for communication of their decisions, the majority of RECs would comply with the Directive requirement of a maximum 60 day period for the assessment of MCT.

[Nutritional effect of bariatric surgery with Scopinaro operation. Analysis of 40 cases]. / Repercusión nutricional de la cirugía bariátrica según técnica de Scopinaro: análisis de 40 casos.

OBJECTIVES: To analyze the influence of bariatric surgery over nutritional status in patients with morbid obesity after 1 year of following. To know the influence of specific factors as age, sex and common channel's length. DESIGN: Retrospective study from 1998-2001. SUBJECT: All patients suffering from morbid obesity that had been operated during this period of time, 40 subjects: 28 women and 12 men with a mean age of 38 +/- 12 years old. Were studied. METHODS: We analyzed the variations of weight and other anthropometric measures, biochemical parameters and the micronutrient (vitamins A, D, E, B12, folate, C, zinc, Calcium, Magnesium) status during 1 year of following after surgery. RESULTS: Percentage weight loss was 29.7 +/- 2.9% without sex differences. A significant (p < 0.005) descent of serum cholesterol, triglycerides, and uric acid level as well as liver function markers was observed. All the hyperglycemic disturbances were reverted. 97% and 48% of the patients developed hypovitaminosis A and D respectively, that was correlated to steatorrhea. Vitamin E deficiency was found in 72% of the patients, and zinc deficiency in 68% CONCLUSIONS: Our expected weight loss 1 year after bariatric surgery is 30%, irrespective of sex and age. This loss is accompanied by a significant improvement in metabolic parameters, but the high prevalence of micronutrients deficiency that was found makes an early supplementation and close follow-in of these patients very advisable.

[Enteral nutrition at home: National register for the year 2000]. / Nutrición enteral domiciliaria (NED): Registro Nacional del año 2000.

GOAL: Once again, the NADYA-SENPE Working Group analysed the registered data of Home Enteral Nutrition (HEN) in our country, during the year 2000. MATERIAL AND METHODS: The data were collected through a closed questionnaire included on our web site (www.nadya-senpe.com). Apart from epidemiological information, the form includes the indication to prescribe this treatment, the specific nutritional treatment used and its duration, access path, complications and readmission rate in hospital, follow-up of the treatment, patient's quality of life and progress. All data were processed and analysed by the co-ordinating team. RESULTS: Twenty two hospital participated and 2,986 patients, aged 65.1 +/- 19.7 years, were enrolled. Of these patients, 41.2% were diagnosed with neurological diseases and 33.3% with cancer. The mean time on HEN was 6.3 +/- 4.4 months. Oral nutrition was the preferential route (50.8%), followed by nasoenteral tube (30.5%), and in 17.4% ostomy tubes were placed. Polymeric was the formula composition mainly used (83.2%). Patients were followed (70.1%) by the hospital reference Nutritional Support Unit. The complications related to nutrition included the gastrointestinal (0.25 complications/patient), the mechanical one (0.19 complications/patient), and the metabolic (0.007 complications/patient). Feeding tube need to be replaced 0.3 times/patient/year. The readmission rate, for nutritional problems, was observed in 0.03 patients. At the end of the year, 54.9% of the patients were in the HEN program, and in 30.3% HEN was finish due to different reasons. In 21.9% of the patients no, o light, discapacity degree was found. CONCLUSIONS: Related to previous years, there is an increment in the number of enrolled patients. Neurological diseases and cancer were the more frequent diagnoses in HEN patients. Oral access was the higher feeding route due, probably, to the high prevalence of cancer patients. In spite of the elevated prevalence of neurological diseases, a few number of patients were feed with ostomy tube. Finally, due to the few readmission rate and complications, HEN is a safe treatment in our country.

[Home enteral nutrition. Annual report 1999. NADYA-SENPE Group]. / Nutrición enteral domiciliaria. Informe anual 1999. Grupo NADYA-SENPE.

GOAL: During 1999, as in previous years, the NADYA-SENPE Group has maintained an annual register of patients with Artificial Nutrition at Home in order to keep up to date our available knowledge of this therapy. The present paper analyzes the results of the sixth National Register of patients under treatment with Enteral Nutrition at Home corresponding to 1999, produced with the co-operation of twenty-three centres in the Spanish national health network. MATERIAL AND METHODS: The data were collected through a closed questionnaire included on our web site (www.nadya-senpe.com). Apart from epidemiological information, the form includes the indication that led to the prescription of nutrition, nutritional treatment, access path, complications and admissions to hospital, follow-up of the treatment, patients' quality of life and progress. All of the data are processed by the co-ordinating team. The Nutrition Unit at La Paz Teaching Hospital in Madrid has acted as the group co-ordinator. RESULTS: During 1999, a total of 2,262 patients at the twenty-three collaborating centres followed treatment with Home Enteral Nutrition (NED in its Spanish acronym). The mean age was 63.6 (19.67 years (males: 57.6%; females: 42.3%). The mean time with nutritional treatment is 5.89 (4.25 months. The neurological alterations (37.5%) and neoplasias (36.8%) were the most frequent indications for NED. Most patients used oral administration (50.7%), the use of artificial routes is less frequent, with 5NG being used on 27.9% and PEG on 12.7%. The polymeric formulas are the ones most commonly used (87.7%). The number of complications recorded amounted to 1,403 episodes, representing 0.62 complications per patient per year, of which 40.8% were gastro-intestinal (0.26 complications per patient per year) and 18.7% were mechanical complications, with only 9 recorded cases of bronchoaspiration. It was necessary to admit patients to hospital on 836 occasions (0.38 admissions per patient), albeit generally for causes not associated with nutrition (86.1%). At year-end, 51.4% of patients continued to receive nutritional support. CONCLUSIONS: Enteral nutrition at home is a safe technique whose use is growing in Spain. It requires the existence of appropriately equipped nutrition teams as well as the collaboration of the Primary Health Care services and the suitable training of patients and relatives. It is essential to progress more deeply into the development and application of clinical routes that provide a clear and concise methodology covering all nutrition-related aspects. In itself, nutrition is a therapeutic alternative regardless of whether access is obtained through a natural or an artificial route. It is necessary for the persons responsible for health-care administration to realize that the appropriate nutrition of patients leads to an improvement in their general health, a shorter course for their illness and, therefore, a reduction in costs.

Quality of life and economic features in elderly asthmatics.

BACKGROUND: In the geriatric population, asthma tends to be overlooked. Moreover, typical symptoms of asthma may mimic chronic bronchitis and emphysema. OBJECTIVE: To compare the characteristics of asthma between elderly (>/=65 years) and adult (<65 years) asthma patients with regard to asthma severity, health-related quality of life, and direct expenditures for medical care generated by the disease. METHODS: A cross-sectional study was made in the asthmatic population older than 14 years in the area of Barcelona, Spain. Asthma severity was determined according to the International Consensus criteria of 1992. St. George's Respiratory Questionnaire (SGRQ) was used to measure the quality of life. Direct costs were calculated registering all costs generated by each patient per year. RESULTS: The study population consisted of 282 adult asthmatics and 51 elderly asthmatics. Asthma was more severe in the elderly group (mild 10%, moderate 35%, severe 55%) than in the adult group (mild 47%, moderate 35%, severe 18%). Elderly asthmatics had significantly higher total SGRQ scores (48 vs. 35, p < 0.001) than adult asthmatics, as well as significantly higher scores for all subscales. Asthma-derived direct costs in elderly asthmatics (mean USD 1,490 vs. USD 773) were double those in adult asthmatics, mainly due to higher costs of hospitalization and medication in the elderly. CONCLUSIONS: Asthma in elderly people as compared with asthma in adulthood was more severe and was associated with a worse health-related quality of life, and significantly higher expenditures for medical care.

Costs of asthma according to the degree of severity.

An increase in asthma-related morbidity and mortality has been reported recently, resulting in a substantial increase in the economic impact of this condition. Little information is available relating to the costs of asthma depending on the degree of severity of the disease. Total, direct and indirect costs generated by asthma patients who sought medical care for asthma control over a one-year period in a northern area of Spain were determined. Data were obtained from the patients themselves and severity of illness was classified into mild, moderate and severe according to the International Consensus Report on Diagnosis and Treatment of Asthma, 1992. The average total annual asthma-derived cost was estimated at US$2,879 per patient, with averages of US$1,336 in mildly asthmatic patients, US$2,407 in moderate asthma and US$6,393 in severe asthma. At all levels of severity, indirect costs were twice as high as direct costs, and at the same degree of severity, direct costs due to medication and hospitalization were higher among females than males. A minority of severe asthmatics incurred some 41% of the total costs. The cost of asthma was surprisingly high and varied substantially depending on the degree of severity of the disease. Further knowledge of the costs of asthma across various levels of severity will contribute to a better characterization of optimal intervention strategies for asthma care.

[Clinical characteristics and morbidity in stable asthma. A descriptive analysis of asthma in a Mediterranean community]. / Características clínicas y morbilidad en el asma estable. Análisis descriptivo del asma en una comunidad mediterránea.

UNLABELLED: Scarce clinical and epidemiological data related to asthma are available in Spain. OBJECTIVES: a) to determine the severity of disease and morbidity among symptomatic asthmatics, and b) to determine whether international recommendations for the treatment of asthma are being followed. A prospective descriptive study enrolling asthmatics older than 14 years of age who experienced symptoms within the past year. The study was performed in the Osona district, a semi-rural area north of Barcelona. Spirometric tests were given and case histories taken, including symptoms caused by the disease. The international guidelines analyzed were those published in 1992 by the National Institutes of Health for the International Consensus Report on Diagnosis and Treatment of Asthma. We studied 333 patients; 214 (64%) were women and 119 (36%) men. Asthma was mild in 140 (42%), moderate in 116 (35%) and severe in 77 (23%). The need for short-term oral corticosteroids, visits to primary care physicians, and missed work days were all significantly greater among patients with severe asthma than for those with mild or moderate asthma. However, 23% of the patients with mild asthma missed work at least once. Drugs used were beta-adrenergic agonists of short duration of effect (76%) and inhaled corticosteroids (66%). CONCLUSIONS: a) in most symptomatic asthma patients, disease is mild; b) although patients with severe asthma have higher rates or morbidity, patients with mild disease also have marked symptoms; c) the drugs used for treatment are in compliance with the 1992 international guidelines.

[The ultrashort bowel syndrome: the surgical treatment of an exceptional case]. / Síndrome de intestino ultracorto: tratamiento quirúrgico de un caso excepcional.

An exceptional case of a 16-year-old boy who accidentally lost all of the small bowel (except the proximal 5 cm. of jejunum), and also 10 cm of transverse colon and a small part of the middle and upper rectum, is presented. After suffering severe medical complications derived from prolonged and uninterrupted total parenteral nutrition for more than one year, with no oral intake except fluids, the patient underwent intestinal lengthening of all the residual bowel up to the sigmoid colon, with antiperistaltic anastomosis and sigmoid J pouch with myotomy. Several months after the operation the patient returned to his normal activities and is fed with a free-diet, complemented or not with nocturnal enteral and parenteral feeding, depending on the circumstances and weight variations. Lengthening of the large bowel together with the rest of surgical gestures here performed has not been published previously.