Middle-term outcomes of gatekeeper implantation for fecal incontinence

BACKGROUND Intersphincteric injectable bulking agents are one of the current treatment options for fecal incontinence, failing behavioral and medical therapy. Gatekeeper showed promising short-term results, but long-term outcomes are unknown. OBJECTIVE The purpose of this study was to clinically evaluate a prospective cohort of fecal incontinence patients up to 36 months after implantation of Gatekeeper. DESIGN This was a prospective clinical study. SETTINGS The study was conducted at a large university tertiary care hospital. PATIENTS Consecutive female patients were eligible if fecal incontinence onset was ≥6 months before the first visit and symptoms were refractory to standard conservative measures. INTERVENTIONS All of the patients underwent implantation of 4 or 6 Gatekeeper prostheses. Three-dimensional endoanal ultrasonography and high-resolution anorectal manometry were performed preoperatively and postoperatively at 2 and 3 months after implantation. MAIN OUTCOME MEASURES The Cleveland Clinic Fecal Incontinence score was calculated at baseline and 1, 3, 12, 24, and 36 months postoperatively. RESULTS Twenty patients (all women; median age, 59 y) were enrolled, and all implants were uneventful. Postoperative endoanal ultrasonography showed normal prosthesis localization in 16 patients (80%). At manometry, mean anal resting pressure significantly improved (57.8 ± 7.5 mm Hg; p = 0.0004). Mean preoperative Cleveland Clinic Fecal Incontinence score was 12.4 ± 1.8, with significant improvements initially documented at 3 months (4.9 ± 1.5; p < 0.0001) and sustained up to 36 months (4.9 ± 1.7; p < 0.0001). Patients receiving only 4 (compared with 6) prostheses and those experiencing pudendal neuropathy (compared with those who did not) showed significantly higher Cleveland Clinic Fecal Incontinence score values in the middle term. LIMITATIONS The study was limited by its small sample size and absence of quality-of-life data. CONCLUSIONS Initial improvements after Gatekeeper implantation for fecal incontinence are sustained in the middle term. Accurate preoperative evaluation of coexistent clinical conditions that may negatively affect outcomes is recommended for patient selection. See Video Abstract at http://links.lww.com/DCR/B109. RESULTADOS A MEDIANO PLAZO EN LA IMPLANTACION DE GATEKEEPER PARA LA INCONTINENCIA FECAL: Los agentes de volumen inyectables interesfintericos, son opciones actuales de tratamiento para la incontinencia fecal, ante fallas de terapias conductuales y medicas. Gatekeeper mostro resultados prometedores a corto plazo, pero resultados a largo plazo aun son desconocidos.Evaluar clinicamente una cohorte prospectiva de pacientes con incontinencia fecal, hasta 36 meses despues de la implantacion de Gatekeeper.Estudio clinico prospectivo.El estudio se realizo en un gran hospital universitario de atencion terciaria.Fueron elegibles pacientes femeninas consecutivas, si el inicio de la incontinencia fecal, fue al menos 6 meses antes de la primera visita, y que los sintomas fueron refractarios a las medidas conservadoras estandarizadas.Todas las pacientes fueron sometidas a implantacion de 4 o 6 protesis Gatekeeper. Se realizo ecografia endoanal de 3D y manometria anorrectal de alta resolucion, antes de la implantacion y despues a los 2 y 3 meses.Se calculo el puntaje de incontinencia fecal de la Cleveland Clinic al inicio, y a los 1, 3, 12, 24 y 36 meses despues de la operacion.Se inscribieron veinte pacientes (todas mujeres; con edad media de 59 anos), y todos los implantes transcurrieron sin incidentes. La ecografia endoanal postoperatoria, mostro localizacion normal de la protesis en 16 (80%) pacientes. A la manometria, la presion media de reposo anal, mejoro significativamente (57.8 ± 7.5 mmHg, p = 0.0004). La puntuacion media preoperatoria de la incontinencia fecal de la Cleveland Clinic, fue de 12.35 ± 1.75, con mejoras significativas documentadas inicialmente a los 3 meses (4.9 ± 1.5, p