Small-incision cholecystectomy (through a cylinder retractor) under local anaesthesia and sedation: a prospective observational study of five hundred consecutive cases.

BACKGROUND: Transcylindrical cholecystectomy (TC) can be performed under local anaesthesia and sedation (LAS) in ambulatory surgery (AS). The aim of this study was to assess the feasibility and results of TC under LAS. METHODS: TC under LAS was proposed to 583 consecutive patients with cholelithiasis in an AS unit. For the TC procedure, a cylindrical retractor with a transparent plunger was inserted into the hepatocystic triangle, and cholecystectomy was performed through the retractor with reusable open instruments. Pre-, intra-, and post-operative variables were prospectively registered, including complications, reasons for conversion to general anaesthesia (GA), non-programmed admissions, readmissions, pain assessments, and satisfaction with the procedure. RESULTS: Five hundred patients were eligible for LAS, with GA being required in 128 (25.6%) of them. AS was programmed for 447 patients. The rates of non-programmed admissions, readmissions, and conversion to laparotomy were 8.7% (39), 0.8% (4), and 2.6% (13), respectively. There was no main bile duct injury. At 24 h, physical status was good or excellent in 80.4% of the patients. A history of acute cholecystitis, male sex, a body mass index (BMI) ≥ 39.5 kg/m2, and non-suspected acute cholecystitis were found to be independent variables associated with conversion to GA. CONCLUSIONS: TC under LAS is a safe procedure in AS and is feasible in 74% of cholelithiasis patients. Male sex, BMI, gallbladder wall thickness, and a history of acute cholecystitis are factors that increase the probability of conversion to GA. This prospective study was approved by the ethics committee of Badajoz for patient protection for biomedical research and has been retrospectively registered under the research registry UIN: researchregistry3979.

Estudio longitudinal de adherencia, satisfacción y efectividad del tratamiento antirretroviral administrado una vez al día, frente a dos veces al día, en una cohorte española de infectados por el VIH (estudio CUVA: cualquiera una vez al día) / Longitudinal study on adherence, treatment satisfaction, and effectiveness of once-daily versus twice-daily antiretroviral therapy in a Spanish cohort of HIV-infected patients (CUVA study)

Introducción. La adherencia es esencial para el éxito del tratamiento antirretroviral (TAR), y la complejidad de la pauta es una barrera para el cumplimiento del TAR. La administración del TAR una vez al día (QD) reduce la complejidad al disminuir el número de tomas y potencialmente el de pastillas. El objetivo del estudio fue conocer el grado de adherencia y de satisfacción de los pacientes, en función de usar pautas QD frente a dos veces al día (BID), cuando la experiencia con QD era aún escasa. Métodos. Estudio observacional, longitudinal y multicéntrico. Se incluyeron TAR de inicio (I), simplificaciones del TAR previo (S) y TAR de rescate (R). Se realizó visita inicial, y posteriormente a los 3 y 6 meses. Para evaluar la adherencia se utilizó un cuestionario previamente validado. La satisfacción con el TAR fue medida por personal independiente mediante una escala visual analógica (EVA). Resultados. Se incluyeron un total de 978 pacientes (entre los meses de mayo y diciembre de 2002). La media de pastillas diarias fue de 5 QD frente a 6,1 BID. La carga vírica a los 6 meses fue indetectable en el 83,7% (I), el 87,5% (S) y el 57,4% (R), sin diferencias significativas entre QD y BID. La adherencia (el 61,4% QD frente al 53,2% BID; p < 0,05) y la satisfacción con el TAR (el 54,4% QD frente al 41,2% BID; p < 0,05) fueron significativamente mejores en las pautas QD. El análisis multivariable mostró como variables explicativas para: a) adherencia al TAR (odds ratio [OR]; intervalo de confianza [IC] del 95%): la satisfacción con el TAR (1,53; 1,30-1,80), apoyo familiar (1,25; 0,98-1,61), años de infección por el virus de la inmunodeficiencia humana (VIH) (0,97; 0,94-1,003) y la adicción intravenosa (0,83; 0,70-0,99); b) satisfacción con el TAR: grupo de simplificación (1,70; 1,22-2,34); pauta QD (1,33; 1,13-1,56); años de infección por el VIH (0,95; 0,93-0,98); estadio C (0,85; 0,73-1,01), y c) carga viral < 400 copias/ml: naïve (5,08; 3,14-8,22) y adherencia (1,57; 1,13-2,17). Conclusión. Las pautas QD resultaron tan efectivas como las BID, mostrando una adherencia y satisfacción con el tratamiento significativamente mejores. Esto podría afectar positivamente la eficacia a largo plazo (AU)

Introduction. Adherence is essential for successful antiretroviral therapy (ART), but complex dosing schedules compromise the adherence to and efficacy of this treatment. Once-daily (QD) ART simplifies treatment by lowering the dosing frequency and pill burden. The aim of this study, performed when QD regimens were still limited, was to determine the degree of adherence and patient satisfaction of QD dosing versus twice-daily dosing (BID) of ART. Methods. Non-interventional, multicenter, longitudinal study, including initial (I), simplification (S), and rescue (R) therapies. Medical visits were performed at baseline, and at 3 and 6 months. A validated, structured questionnaire was used to assess adherence, and a visual analogical scale applied by independent observers was used to assess satisfaction. Results. From May to December 2002, 978 patients were recruited. Average pill burden was 5 in QD vs. 6.1 in BID regimens. Undetectable viral load was achieved at 6 months in 83.7% (I), 87.5% (S), and 57.4% (R) of patients, with no significant differences between QD and BID. Adherence and satisfaction with ART were both significantly better in QD vs. BID regimens: 61.4% vs. 53.2% (P < .05) and 54.4% vs. 41.2% (P < .05), respectively. Multivariate analysis revealed the following variables to account for 1) Adherence to ART (OR; 95% CI): treatment satisfaction (1.53, 1.30-1.80), family support (1.25, 0.98-1.61), years of HIV infection (0.97, 0.94-1.003) and intravenous drug use (0.83, 0.70-0.99); 2) Satisfaction with ART: simplification group (1.70, 1.22-2.34), QD therapy (1.33, 1.13-1.56), years of HIV infection (0.95, 0.93-0.98), and CDC stage C (0.85, 0.73-1.01); and 3) Undetectable viral load: naive group (5.08, 3.14-8.22) and adherence (1.57, 1.13-2.17). Conclusion. QD antiretroviral schedules appear to be as effective as BID regimens, with better adherence and treatment satisfaction. This may positively affect treatment efficacy at long-term (AU)