Celarier, S.
Monziols, S.
Francois, M. O.
Assenat, V.
Carles, P.
Capdepont, M.
Fleming, C.
Rullier, E.
Napolitano, G.
Denost, Q. http://orcid.org/0000-0003-3088-5244
Article History
Received: 3 September 2019
Accepted: 4 February 2020
First Online: 22 February 2020
Ethics approval and consent to participate
: Informed and enlightened consent will be obtained from all study participants. One original copy of the information note and signed consent will be given to the patient and the other original copy will be retained by the investigator as part of the study documents in an area inaccessible to third parties.The sponsor and the investigator will ensure that this research is carried out in accordance with the law n ° 2012–300 of March 5, 2012, relating to research involving the human being, as well as in agreement with Good Clinical Practice (ICH version 4 of November 9, 2016 and decision of November 24, 2006) and the Declaration of Helsinki (which can be found in its full version at ExternalRef removed). Except in emergency situations requiring the implementation of specific therapeutic acts, the investigators undertake to respect the protocol in all points, especially with regard to the collection of consent and notification and follow-up of serious adverse events. This research received approval from the Committee for the Protection of Persons (CPP) by CPP Ouest 1 - TOURS (Folder number: 2018 T2–21 (2018-A03028–47) (CHUBX 2018/42)) and was the subject of information to the ANSM. The University Hospital of Bordeaux, sponsor of this research, has taken out a civil liability insurance policy with HDI Global SE in accordance with the provisions of the Public Health Code. The data recorded during this research will be recorded in digital format in the colorectal surgery department of Haut-Lévêque Hospital (Bordeaux University Hospital) with respect to law n ° 78–17 of January 6, 1978 relating to data processing, files, and freedoms modified by law 2004–801 of August 6, 2004. This research falls within the framework of “Reference Methodology” (MR-001) in the application of the provisions of article 54 paragraph 5 of the amended law of January 6, 1978, relating to information, files, and freedoms. This change was approved by decision of January 5, 2006, updated on July 21, 2016. The Bordeaux University Hospital signed a commitment of conformity to this “Reference Methodology”. This search is saved in the ID-RCB database under 2018-A03028–47. This research is registered at ExternalRef removed.
: Not applicable.
: The authors declare that they have no competing interests.