Ensayo clínico aleatorizado sobre la puesta a plano, curetaje y marsupialización de bordes frente a la técnica de Karydakis en el tratamiento del sinus pilonidal

INTRODUCCION El sinus pilonidal (SP) es una patologia frecuente que afecta fundamentalmente a pacientes jovenes. Su tratamiento es esencialmente quirurgico. Hasta el momento no se ha descrito una tecnica ideal para su resolucion, que cumpla los criterios de baja morbilidad y recurrencia, que pueda realizarse en regimen de cirugia mayor ambulatoria, que tenga un resultado estetico satisfactorio y que facilite una reincorporacion sociolaboral precoz. Algunos autores opinan que las tecnicas tradicionales son demasiado agresivas teniendo en cuenta la condicion de benignidad del SP. De ahi, que se planteen otras cirugias minimamente invasivas para su tratamiento como la Puesta a plano, curetaje y marsupializacion de bordes (PPCYM). HIPOTESIS La seguridad terapeutica de la PPCYM no sera inferior a la de la tecnica de Karydakis al mes de la intervencion. La seguridad de la tecnica, unido a otros factores como la eficacia, el dolor postoperatorio, el bienestar subjetivo y parametros relacionados con la eficiencia de la PPCYM permitiran afianzar su utilizacion como alternativa quirurgica en el tratamiento del SP. OBJETIVOS Demostrar la no inferioridad en terminos de seguridad terapeutica de la PPCYM frente al Karydakis a los 30 dias de la intervencion. Comparar la eficacia terapeutica, el dolor postoperatorio, el bienestar subjetivo de los pacientes y determinados aspectos sobre la eficiencia en ambos grupos de tratamiento. MATERIAL Y METODO Se realizo un ensayo clinico randomizado en pacientes con SP en el Hospital General Universitario Reina Sofia de Murcia (HGURS) entre julio de 2014 y marzo de 2017. Los sujetos se aleatorizaron para ser intervenidos mediante PPCYM o Karydakis. La recogida de datos se realizo a los 15 dias, 30 dias, 3 meses y 18 meses tras la cirugia. Para valorar la seguridad terapeutica de ambas tecnicas, se realizo un analisis de no inferioridad comparando la proporcion de complicaciones postoperatorias precoces (CPP) relacionadas con la herida quirurgica en el primer mes tras la cirugia. Respecto a la eficacia terapeutica se tuvo en cuenta la proporcion de sujetos en cada grupo con recidiva del SP hasta los 18 meses tras la cirugia. En cuanto al dolor, se realizo una medida basal preoperatoria y varias medidas postoperatorias, y se compararon los resultados entre ambos grupos de tratamiento. En relacion al bienestar subjetivo del paciente, para evaluar la calidad de vida relacionada con la salud (CVRS) se compararon los datos obtenidos con los cuestionarios SF-36 en ambos grupos de tratamiento. Se comparo ademas, el grado de satisfaccion con el resultado estetico con las tecnicas estudiadas. Para evaluar la eficiencia terapeutica de las tecnicas se tuvieron en cuenta la duracion hasta la reincorporacion sociolaboral, el tiempo quirurgico empleado, el numero de visitas no programadas y el tiempo de cicatrizacion. RESULTADOS Se incluyeron un total de 122 pacientes (62 intervenidos mediante PPCYM y 60 mediante Karydakis). La edad media fue de 24,5±9,3 anos y el 67,2% eran varones. Las caracteristicas basales de ambos grupos fueron similares. La duracion media de la intervencion fue significativamente menor en el grupo de PPCYM, sin diferencias entre ambos grupos respecto al resto de variables relacionadas con el proceso quirurgico. Durante el seguimiento, se objetivo una menor proporcion de CPP con la PPCYM y no hubo diferencias estadisticamente significativas entre ambos grupos de tratamiento respecto a la proporcion de recidivas, al dolor y al bienestar subjetivo en general. La mayoria de parametros relacionados con la eficiencia terapeutica, demostraron que la PPCYM era mas eficiente que la tecnica de Karydakis en terminos generales. Ademas, el tabaco y la obesidad se mostraron como factores de riesgo para el desarrollo de CPP en el analisis univariante y multivariante para la prediccion de las mismas. CONCLUSIONES La Puesta a plano, curetaje y marsupializacion de bordes es mas segura y mas eficiente que la tecnica de Karydakis. En terminos generales, la Puesta a plano, curetaje y marsupializacion de bordes no es inferior en eficacia terapeutica, dolor postoperatorio y bienestar del paciente, respecto a la tecnica de Karydakis. El tabaquismo y la obesidad son factores de riesgo para el desarrollo de complicaciones postoperatorias precoces tras la cirugia del sinus pilonidal. INTRODUCTION Pilonidal sinus (PNS) is a common disorder that primarily affects young patients. Its treatment is essentially surgical. No ideal technique which meets the criteria of low morbidity and recurrence, which can be performed as major outpatient surgery, which has a satisfactory aesthetic result and which facilitates an early social and occupational reintegration, has been described to date for its cure. Some authors believe that tradicional techniques are too aggressive considering the benign nature PNS. Hence, others surgical procedures should be considered for treatment, such as unroofing, curettage and marsupialization of the edges of the skin (UCM). HYPOTHESIS The therapeutic safety of UCM shall not be lower than that of the Karydakis technique one month after the procedure. The safety of the technique, together with other factors such as efficacy, postoperative pain, subjective well-being and parameters related with the therapeutic efficiency of the UCM, shall help anchor its use as a surgical alternative in the treatment of PNS. OBJECTIVES To demonstrate the non-inferiority in terms of therapeutic safety of UCM against the Karydakis technique 30 days after the procedure. To compare the therapeutic efficacy, postoperative pain, subjective well-being of patients and certain efficiency-related aspects in both treatment groups. MATERIALS AND METHOD A randomised clinical trial was conducted on patients with PNS at the Hospital General Universitario Reina Sofia in Murcia, Spain between July 2014 and March 2017. Patients were randomised to be operated on using UCM or Karydakis. Data collection was performed at 15 days, 30 days, 3 months and 18 months after surgery. To assess the therapeutic safety of both techniques, a non-inferiority analysis was performed comparing the proportion of early postoperative complications (EPCs) related to the surgical wound in the first month after surgery. Regarding therapeutic efficacy, the proportion of patients in each group with recurrence of PNS was taken into account for 18 months after surgery. Regarding pain, a preoperative baseline and several postoperative measures were performed, and the results were compared between the two groups of treatment. Regarding the subjective well-being of the patient, the data obtained from the SF-36 questionnaires were compared in both treatment groups to evaluate health-related quality of life. The degree of satisfaction with the aesthetic result using the techniques in question was also compared. In order to evaluate the therapeutic efficacy of the techniques, the time until social and occupational reincorporation, the surgery time required, the number of unscheduled visits and the healing time, were taken into account. RESULTS A total of 122 patients were enrolled (62 operated on using UCM and 60 using Karydakis). The mean age was 24.5 ± 9.3 years and 67.2% were males. The baseline characteristics of both groups were similar. The mean duration of the operation was significantly lower in the UCM group, with no differences between the two groups concerning the other variables related to the surgical procedure. During follow-up, a lower proportion of EPCs were observed with UCM and there were no statistically significant differences between the two treatment groups regarding the rate of recurrences, pain and subjective well-being in general. Most parameters related to therapeutic efficiency showed that UCM was more efficient than the Karydakis technique in general terms. In addition, smoking and obesity were shown as risk factors for the development of EPCs in univariate and multivariate analysis for the prediction of said complications. CONCLUSIONS Unroofing, curettage and marsupialization is safer and more efficient than the Karydakis technique for pilonidal sinus surgery. In general terms, Unroofing, curettage and marsupialization is not inferior in therapeutic efficacy, postoperative pain and patient well-being compared to the Karydakis technique. Smoking and obesity are risk factors for the development of early postoperative complications following pilonidal sinus surgery. Unroofing, curettage and marsupialization is an alternative comparable to the Karydakis technique.