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Study protocol for a multicenter prospective controlled and randomized trial of transanal total mesorectal excision versus laparoscopic low anterior resection in rectal cancer

  • X. Serra-Aracil
  • A. Zárate
  • L. Mora
  • S. Serra-Pla
  • A. Pallisera
  • J. Bonfill
  • J. Bargalló
  • A. Pando
  • S. Delgado
  • E. Balleteros
  • C. Pericay
Clinical Study Protocol

Abstract

Purpose

Compared with the open approach, laparoscopic total mesorectal excision (TME) achieves faster patient recovery, reduces morbidity rates, and shortens hospital stay. However, in laparoscopic low anterior resection (L-LAR), conversion to open surgery is required in almost 20% of cases. Transanal TME (Ta-TME) combined with laparoscopy, also called hybrid natural orifice transluminal endoscopic surgery (NOTES), is a less invasive procedure that can overcome some of the limitations of laparoscopic rectal surgery. In this study, we aim to determine whether Ta-TME has a lower rate of conversion to open surgery than L-LAR, and thus achieves faster patient recovery without altering the pathological, functional, or oncological results. The main objective is to compare the results for conversion to open surgery between Ta-TME and L-LAR.

Methods

Multicenter, prospective randomized controlled study of patients diagnosed with rectal adenocarcinoma who will be randomly allocated to Ta-TME or L-LAR groups after the application of inclusion and exclusion criteria. The main endpoint is conversion to open surgery and the secondary endpoints are general morbidity and mortality and hospital stay. Demographic, surgical, and pathological variables will also be studied, along with quality of life and survival. A sample size of 53 patients per group is calculated. With an estimated loss of 10%, the final sample required will be 116 patients.

Conclusions

Ta-TME achieves a lower conversion rate to open surgery than L-LAR, thus improving patient recovery and reducing overall morbidity.

Trial registration

ClinicalTrials.gov Identifier: NCT02550769. Registration no. Ethical and Clinical Research Committee, Parc Taulí University Hospital: ID 2014/064.

Keywords

Rectal cancer Laparoscopic low anterior resection Total mesorectal excision TME Transanal total mesorectal excision Ta-TME Rectal hybrid NOTES 

Notes

Acknowledgements

We thank all the members of the multidisciplinary committee for colorectal tumors of the hospital for their support. We thank Michael Maudsley for help with the English translation.

Authors’ contributions

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

Funding

This study was funded by a grant from the Fundación Parc Taulí Research prize IDCSALUD - Hospital General de Catalunya, 2015.

Compliance with ethical standards

Competing interests

The authors declare that they have no competing interests.

Consent for publication

Not applicable.

Ethics approval and consent to participate

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

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  • X. Serra-Aracil
    • 1
  • A. Zárate
    • 1
  • L. Mora
    • 1
  • S. Serra-Pla
    • 1
  • A. Pallisera
    • 1
  • J. Bonfill
    • 2
  • J. Bargalló
    • 3
  • A. Pando
    • 4
  • S. Delgado
    • 4
  • E. Balleteros
    • 5
  • C. Pericay
    • 6
  1. 1.Coloproctology Unit, General and Digestive Surgery DepartmentParc Tauli University Hospital, Universitat Autonoma de BarcelonaBarcelonaSpain
  2. 2.General and Digestive Surgery DepartmentHospital General de CatalunyaBarcelonaSpain
  3. 3.General and Digestive Surgery DepartmentHospital de TerrassaTerrassaSpain
  4. 4.Coloproctology Unit, General and Digestive Surgery DepartmentHospital Universitario Mutua de TerrassaTerrassaSpain
  5. 5.Radiology DepartmentParc Tauli University Hospital, Universitat Autonoma de BarcelonaBarcelonaSpain
  6. 6.Medical Oncology DepartmentParc Tauli University Hospital, Universitat Autonoma de BarcelonaBarcelonaSpain

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