Colonic J-pouch or straight colorectal reconstruction after low anterior resection for rectal cancer: Impact on quality of life and bowel function: A multicenter prospective randomized study

BACKGROUND Patient-reported outcomes associated with different bowel reconstruction techniques following anterior resection for rectal cancer are still a matter of debate. OBJECTIVE This study aimed to assess quality of life and bowel function in patients who underwent colonic J-pouch or straight colorectal anastomosis reconstruction after low anterior resection. DESIGN Bowel function and quality of life were assessed within a multicenter randomized trial. Questionnaires were administered before the surgery (baseline) and at 6, 12, and 24 months after surgery. SETTINGS Patients were enrolled by 19 centers. The enrollment started in October 2009 and was stopped in February 2016. The study was registered at www.clinicaltrials.gov (Identifier: NCT01110798). PATIENTS Patients who underwent low anterior resection for primary mid-low rectal cancer and who were randomly assigned in a 1:1 ratio to receive either stapled colonic J-pouch or straight colorectal anastomosis were selected. MAIN OUTCOME MEASURES The primary outcomes measured were quality of life and bowel function. RESULTS Of the 379 patients who were evaluable, 312 (82.3%) completed the baseline, 259 (68.3%) the 6-month, 242 (63.9%) the 12-month, and 199 (52.5%) the 24-month assessment. Bowel functioning and quality of life did not significantly differ between arms for almost all domains. The total bowel function score, the urgency, and the stool fractionation scores significantly worsened after surgery and remained impaired over time in both arms (p < 0.0032), whereas constipation improved after surgery but recovered to baseline levels from 1 year onward (p < 0.0036). All patients showed a significant and continuous improvement in emotional functioning (p < 0.0013) and future perspective (p < 0.0001) from baseline to the end of the study. LIMITATIONS Limitations of the study include missing data, which increased over time; the possibility that some treatments have slightly changed since the study was conducted; and investigators not blind to treatment allocation. CONCLUSION The findings of this study do not support the routine use of colonic J-pouch reconstruction in patients with rectal cancer who undergo a low anterior resection. See Video Abstract at http://links.lww.com/DCR/B328. BOLSA J COLONICA O RECONSTRUCCION COLORRECTAL RECTA DESPUES DE RESECCION ANTERIOR BAJA PARA CANCER RECTAL: IMPACTO EN LA CALIDAD DE VIDA Y LA FUNCION INTESTINAL: UN ESTUDIO ALEATORIZADO PROSPECTIVO MULTICENTRICO: Los resultados informados por el paciente asociados con diferentes tecnicas de reconstruccion intestinal despues de la reseccion anterior para el cancer de recto aun son tema de debate.Evaluar la calidad de vida y la funcion intestinal en pacientes que se sometieron a una bolsa en J colonica o reconstruccion de anastomosis colorrectal recta despues de una reseccion anterior baja.La funcion intestinal y la calidad de vida se evaluaron en un ensayo aleatorizado multicentrico. Los cuestionarios se administraron antes de la cirugia (basal) y a los 6, 12 y 24 meses despues de la cirugia.Los pacientes fueron incluidos en 19 centros. La inscripcion comenzo en Octubre de 2009 y se detuvo en Febrero de 2016. El estudio se registro en www.clinicaltrials.gov (Identificador: NCT01110798).Pacientes que se sometieron a reseccion anterior baja por cancer rectal primario medio-bajo y que fueron aleatorizados en una proporcion de 1: 1 para recibir bolsa J colonica con grapas o anastomosis colorrectal recta.calidad de vida y funcion intestinal.De los 379 pacientes que fueron evaluables, 312 (82.3%) completaron la evaluacion inicial, 259 (68.3%) a los 6 meses, 242 (63.9%) a los 12 meses y 199 (52.5%) a los 24 meses. . El funcionamiento intestinal y la calidad de vida no difirieron significativamente entre los dos grupos en casi todos los dominios. La puntuacion total de la funcion intestinal, la urgencia y las puntuaciones de fraccionamiento de las heces empeoraron significativamente despues de la cirugia y continuaron con el tiempo extra en ambos grupos (p