Evaluación de la colecistectomia laparoscópica en régimen ambulatorio. Validación de un sistema predictivo de selección de pacientes.

RESUMEN Las ventajas demostradas en el postoperatorio de los pacientes colecistectomizados por vía laparoscópica hacen que actualmente la inmensa mayoría de las CL se realicen en régimen de Cirugía de Corta estancia. Reddick y Olsen aportan el concepto de CL ambulatoria en 1990. Sin embargo, la CL no ha sido aceptada de manera generalizada como procedimiento susceptible de manejo ambulatorio, debido al papel que atribuyen ciertos autores a la detección tardía de complicaciones derivadas del proceso quirúrgico. Los objetivos de nuestro estudio fueron: aportar nuestra experiencia en el desarrollo, implantación e implementación de una serie de 410 CL en un programa de CMA; evaluar el grado de satisfacción postoperatoria y calidad percibida por el paciente intervenido mediante una encuesta de satisfacción protocolizada postoperatoria; y, desarrollar un modelo predictivo de selección de pacientes. Analizamos 410 CL por colelitiasis sintomática realizadas en el periodo comprendido entre Enero de 1999 y Junio de 2003 en la Clínica Quirón en Valencia. Los criterios de selección de los pacientes para CL ambulatoria fueron grado ASA I, II ó III estable, ausencia de complicaciones anestésicas en intervenciones previas, compañía de un adulto competente en el hogar las primeras 24 horas y domicilio situado a menos de 100 kms del lugar de intervención. El procedimiento anestésico fue protocolizado. La técnica de colecistectomía fue la habitual europea, realizando antes y después del procedimiento irrigación subfrénica y subhepática, con una solución de bupivacaína 0.5%. No se realizó colangiografía intraoperatoria (CIO) en ningún caso. El manejo postoperatorio fue realizado en régimen de fast-track sin una infraestructura específica de URPA. El alta hospitalaria fue decidida en base a los siguientes criterios: constantes vitales estables; dolor controlable con analgesia oral; ausencia de N/V; ausencia de sangrado por heridas de los trócares; tolerancia a líquidos establecida; y capacidad de deambulación independiente no asistida. De 410 pacientes, 363 fueron intervencidos de forma ambulatoria estricta (86.8 %), con una estancia hospitalaria media de 6.1 +/- 1.2 horas. Cuarenta y dos pacientes requirieron estancia octurna (10.2%). La mayoría de estos (54%) fueron debidos a causas sociales, por negativa al alta. Finalmente, 5 pacientes fueron ingresados (1.6%). Seis pacientes reingresaron en la Clínica: 2 por vómitos repetidos, 1 debido a un episodio de pancreatitis biliar, 2 por colecciones intraabdominales, y otro por cuadro de oclusión intestinal. El análisis univariante identificó 9 factores relacionados con fracaso de la ambulatorización de la CL: edad superior a 65 años (p=0.006); antecedentes de colecistitis o pancreatitis (p=0.009); hallazgo ecográfico preoperatorio de engrosamiento de pared vesicular (p=0.013); duración de la cirugía superior a 60 minutos (p=0.000); disección dificultosa del triangulo del Calot (p=0.001); disección compleja del lecho hepático (p=0.000); score de dificultad quirúrgica superior a 6 (p=0.000); sangrado de la arteria cística (p=0.007), y características intraoperatorias de la vesícula biliar (p=0.000). El modelo de regresión logística múltiple confirmó como variables independientes: edad superior a 65 años (p=0.021; OR= 2.225; 95%CI: 1.130-4.381), tiempo quirúrgico mayor a 60 minutos (p=0.046; OR= 2.403; 95%CI: 1.106 - 5.685), y score de dificultad mayor a 6 (p=0.034; OR= 3.063; 95%CI: 1.086-8.649). Obtuvimos un modelo predictivo con capacidad predictiva del 91.7% (VPP) con sensibilidad del sistema del 9.7% y especificidad, 31.9%. La calibración del modelo se realizó con el test de bondad de ajuste de Hosmer-Lemeshow (p > 0.05). Las encuestas protocolizadas sobre el grado de calidad percibida fueron completadas en el 100 por cien de los casos. Observamos un mínimo porcentaje de efectos indeseables debidos al procedimiento anestésico-quirúrgico (menor del 3 por ciento) y un mínimo porcentaje de necesidad de consulta médica adicional (2.2%). Existió una elevada consideración positiva de la ambulatorización, aceptando el alta ambulatoria el 77% de los casos, aunque la opción global de estancia nocturna la hubiese elegido un 38% de los pacientes. La satisfacción global del proceso fue considerada como muy positiva en el 86.2% de los pacientes. __________________________________________________________________________________________________Introduction: The aim of our study was to review our experience and to determine a predictive model of factors for unanticipated admissions after ambulatory laparoscopic cholecystectomy (LC). Material and Methods: Between January 1999 and June 2003, 410 consecutive LC were performed as outpatient procedures. We performed univariate analysis and logistic regression models of preoperative and intraoperative variables. Scoring system developed allowed calculating the ambulatorization probability of LC in each patient. Validation and calibration of the model were realized by means of Hosmer-Lemeshow test. Results: 363 patients were strictly ambulatory (86.8%). Forty-two patients required overnight admission (10.2%), most of them due to social factors, and 5 patients were admitted. Predictive factors related to overnight stay or admission were: age of patient over 65 years (p=0.021; OR=2.225; 95%CI: 1.130-4.381), operation duration superior to 60 minutes (p=0.046; OR=2.403; 95%CI: 1.106-5.685), and dissection difficulty intraoperative score superior to 6 (p=0.034; OR=3.063; 95%CI: 1.086-8.649). Right classification index of the predictive system was 91.7% reaching a sensibility of 99.7% and specificity of 31.9%. Protocolized tests about quality grade obtained were completed in 100 % of the cases. Global satisfaction of the patient was 86.2%. Conclusions: Outpatient LC is safe and feasible. Age of the patient, operation duration and complexity of surgical dissection during LC are independent factors influencing ambulatorization rate

A prospective multicentre study evaluating the outcomes of the abdominal wall dehiscence repair using posterior component separation with transversus abdominis muscle release reinforced by a retro-muscular mesh: filling a step

Background This study aimed to evaluate the results of posterior component separation (CS) and transversus abdominis muscle release (TAR) with retro-muscular mesh reinforcement in patients with primary abdominal wall dehiscence (AWD). The secondary aims were to detect the incidence of postoperative surgical site occurrence and risk factors of incisional hernia (IH) development following AWD repair with posterior CS with TAR reinforced by retromuscular mesh. Methods Between June 2014 and April 2018, 202 patients with grade IA primary AWD (Björck’s first classification) following midline laparotomies were treated using posterior CS with TAR release reinforced by a retro-muscular mesh in a prospective multicenter cohort study. Results The mean age was 42 ± 10 years, with female predominance (59.9%). The mean time from index surgery (midline laparotomy) to primary AWD was 7 ± 3 days. The mean vertical length of primary AWD was 16 ± 2 cm. The median time from primary AWD occurrence to posterior CS + TAR surgery was 3 ± 1 days. The mean operative time of posterior CS + TAR was 95 ± 12 min. No recurrent AWD occurred. Surgical site infections (SSI), seroma, hematoma, IH, and infected mesh occurred in 7.9%, 12.4%, 2%, 8.9%, and 3%, respectively. Mortality was reported in 2.5%. Old age, male gender, smoking, albumin level < 3.5 gm%, time from AWD to posterior CS + TAR surgery, SSI, ileus, and infected mesh were significantly higher in IH. IH rate was 0.5% and 8.9% at two and three years, respectively. In multivariate logistic regression analyses, the predictors of IH were time from AWD till posterior CS + TAR surgical intervention, ileus, SSI, and infected mesh. Conclusion Posterior CS with TAR reinforced by retro-muscular mesh insertion resulted in no AWD recurrence, low IH rates, and low mortality of 2.5%. Trial registration Clinical trial: NCT05278117

Practical aspects of high resolution esophageal manometry

High resolution esophageal manometry (HRM) is currently under development as can be seen in the various Chicago classifications. In order to standardize criteria in certain practical aspects with limited scientific evidence, the First National Meeting for Consensus in High Resolution Manometry of the Spanish Digestive Motility Group took place, bringing together a wide group of experts. The proposals were based on a prior survey composed of 47 questions, an exhaustive review of the available literature and the experience of the participants. Methodological aspects relating to the poorly defined analysis criteria of certain new high resolution parameters were discussed, as well as other issues previously overlooked such as spontaneous activity or secondary waves. Final conclusions were drawn with practical applications

Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI) : a phase 3, placebo-controlled, randomised trial

Background: Patients with stable coronary artery disease and diabetes with previous percutaneous coronary intervention (PCI), particularly those with previous stenting, are at high risk of ischaemic events. These patients are generally treated with aspirin. In this trial, we aimed to investigate if these patients would benefit from treatment with aspirin plus ticagrelor. Methods: The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) was a phase 3 randomised, double-blinded, placebo-controlled trial, done in 1315 sites in 42 countries. Patients were eligible if 50 years or older, with type 2 diabetes, receiving anti-hyperglycaemic drugs for at least 6 months, with stable coronary artery disease, and one of three other mutually non-exclusive criteria: a history of previous PCI or of coronary artery bypass grafting, or documentation of angiographic stenosis of 50% or more in at least one coronary artery. Eligible patients were randomly assigned (1:1) to either ticagrelor or placebo, by use of an interactive voice-response or web-response system. The THEMIS-PCI trial comprised a prespecified subgroup of patients with previous PCI. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, or stroke (measured in the intention-to-treat population). Findings: Between Feb 17, 2014, and May 24, 2016, 11 154 patients (58% of the overall THEMIS trial) with a history of previous PCI were enrolled in the THEMIS-PCI trial. Median follow-up was 3·3 years (IQR 2·8–3·8). In the previous PCI group, fewer patients receiving ticagrelor had a primary efficacy outcome event than in the placebo group (404 [7·3%] of 5558 vs 480 [8·6%] of 5596; HR 0·85 [95% CI 0·74–0·97], p=0·013). The same effect was not observed in patients without PCI (p=0·76, p interaction=0·16). The proportion of patients with cardiovascular death was similar in both treatment groups (174 [3·1%] with ticagrelor vs 183 (3·3%) with placebo; HR 0·96 [95% CI 0·78–1·18], p=0·68), as well as all-cause death (282 [5·1%] vs 323 [5·8%]; 0·88 [0·75–1·03], p=0·11). TIMI major bleeding occurred in 111 (2·0%) of 5536 patients receiving ticagrelor and 62 (1·1%) of 5564 patients receiving placebo (HR 2·03 [95% CI 1·48–2·76], p<0·0001), and fatal bleeding in 6 (0·1%) of 5536 patients with ticagrelor and 6 (0·1%) of 5564 with placebo (1·13 [0·36–3·50], p=0·83). Intracranial haemorrhage occurred in 33 (0·6%) and 31 (0·6%) patients (1·21 [0·74–1·97], p=0·45). Ticagrelor improved net clinical benefit: 519/5558 (9·3%) versus 617/5596 (11·0%), HR=0·85, 95% CI 0·75–0·95, p=0·005, in contrast to patients without PCI where it did not, p interaction=0·012. Benefit was present irrespective of time from most recent PCI. Interpretation: In patients with diabetes, stable coronary artery disease, and previous PCI, ticagrelor added to aspirin reduced cardiovascular death, myocardial infarction, and stroke, although with increased major bleeding. In that large, easily identified population, ticagrelor provided a favourable net clinical benefit (more than in patients without history of PCI). This effect shows that long-term therapy with ticagrelor in addition to aspirin should be considered in patients with diabetes and a history of PCI who have tolerated antiplatelet therapy, have high ischaemic risk, and low bleeding risk