TY - JOUR
T1 - Two-stage Turnbull-Cutait pull-through coloanal anastomosis versus coloanal anastomosis with protective loop ileostomy for low rectal cancer. Protocol for a randomized controlled trial (Turnbull-BCN)
AU - Biondo, Sebastiano
AU - Trenti, Loris
AU - Galvez, Ana
AU - Espin-Basany, Eloy
AU - Bianco, Francesco
AU - Romano, Giovanni
AU - Kreisler, Esther
AU - Blanco-Alvarez, Ana
AU - Quiñones-Sanchez, Cristina
AU - Jerez-Gonzalez, Jose
AU - Golda, Thomas
AU - Frago, Ricardo
AU - Fraccalvieri, Domenico
AU - Sanchez-Garcia, Jose L.
AU - De Franciscis, Silvia
PY - 2017/9/1
Y1 - 2017/9/1
N2 - © 2017, Springer-Verlag GmbH Germany. Purpose: The aim of this study was to determine whether patients that underwent ultra-low rectal resection for cancer can benefit from the recently reintroduced two-stage Turnbull-Cutait abdominoperineal pull-through procedure. Methods: Patients with low rectal tumors undergoing radical sphincter-sparing resection are eligible for inclusion in a randomized multicenter study. Whether two-stage Turnbull-Cutait coloanal anastomosis provides significant benefits over hand-sewn coloanal anastomosis and associated lateral ileostomy in terms of postoperative morbidity is the primary endpoint. In addition, the study aims to assess secondary endpoints such as quality of life, fecal incontinence, and locoregional recurrence of the neoplasm. Patients with adenocarcinoma of the lower rectum diagnosed by rigid proctoscopy, with histological confirmation of malignancy, and who are candidates of rectal removal and coloanal anastomosis will be included in a randomized controlled and multicenter trial. Postoperative morbidity is defined as complications that occur within 30 days of the data of the second surgical procedure of the last patient included in the trial. Patients will be followed for a minimum period of 3 years. Conclusions: The two-stage Turnbull-Cutait coloanal anastomosis may constitute an effective surgical alternative in the current approach to the treatment of low rectal cancer without the need of a temporary loop colostomy, preventing the wide range of complications related to stoma surgery. Trial registration: This trial is registered at clinicaltrials.gov (trial number: NCT01766661). This trial is registered in January 10, 2013.
AB - © 2017, Springer-Verlag GmbH Germany. Purpose: The aim of this study was to determine whether patients that underwent ultra-low rectal resection for cancer can benefit from the recently reintroduced two-stage Turnbull-Cutait abdominoperineal pull-through procedure. Methods: Patients with low rectal tumors undergoing radical sphincter-sparing resection are eligible for inclusion in a randomized multicenter study. Whether two-stage Turnbull-Cutait coloanal anastomosis provides significant benefits over hand-sewn coloanal anastomosis and associated lateral ileostomy in terms of postoperative morbidity is the primary endpoint. In addition, the study aims to assess secondary endpoints such as quality of life, fecal incontinence, and locoregional recurrence of the neoplasm. Patients with adenocarcinoma of the lower rectum diagnosed by rigid proctoscopy, with histological confirmation of malignancy, and who are candidates of rectal removal and coloanal anastomosis will be included in a randomized controlled and multicenter trial. Postoperative morbidity is defined as complications that occur within 30 days of the data of the second surgical procedure of the last patient included in the trial. Patients will be followed for a minimum period of 3 years. Conclusions: The two-stage Turnbull-Cutait coloanal anastomosis may constitute an effective surgical alternative in the current approach to the treatment of low rectal cancer without the need of a temporary loop colostomy, preventing the wide range of complications related to stoma surgery. Trial registration: This trial is registered at clinicaltrials.gov (trial number: NCT01766661). This trial is registered in January 10, 2013.
KW - Coloanal anastomosis
KW - Pull-through
KW - Sphincter-sparing rectal resection
KW - Turnbull-Cutait technique
KW - Ultra-low rectal cancer
U2 - 10.1007/s00384-017-2842-4
DO - 10.1007/s00384-017-2842-4
M3 - Article
VL - 32
SP - 1357
EP - 1362
IS - 9
ER -