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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)

  • Clinical Study Protocol
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International Journal of Colorectal Disease Aims and scope Submit manuscript

Abstract

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.

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Acknowledgements

We thank Marta Pulido, MD, for editing the manuscript and editorial assistance and Bernat Miguel for monitoring the study.

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Authors and Affiliations

Authors

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Contributions

All authors contributed to the design and writing of the paper. All authors have read and approved the final manuscript.

Turnbull-BCN study group

Ana Blanco-Alvarez, Cristina Quiñones-Sanchez, and Jose Jerez-Gonzalez (Clinical colorectal nurses Bellvitge Hospital), Thomas Golda, Ricardo Frago, and Domenico Fraccalvieri (Colorectal surgeons Bellvitge Hospital), Jose L Sanchez-Garcia (Colorectal surgeon Vall d’Hebron Hospital), and Silvia De Franciscis (Digestive surgeon G. Pascale Hospital)

Corresponding author

Correspondence to Sebastiano Biondo.

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Funding

The study is funded by Instituto Carlos III, Fondo de Investigación en Salud (FIS), (project PI15/00485), Ministry of Industry and Competitiveness, Government of Spain, and Fondo Europeo de Desarrollo Regional (FEDER). Granted by the Spanish Association of Coloproctology Foundation (FAECP)

Competing interests

The authors declare that they have no competing interests.

Ethics approval and consent to participate

The study has been approved by the local ethics committees of the participating centers.

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Biondo, S., Trenti, L., Galvez, A. et al. 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). Int J Colorectal Dis 32, 1357–1362 (2017). https://doi.org/10.1007/s00384-017-2842-4

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