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Article History

Received: 8 February 2018

Accepted: 4 April 2018

First Online: 2 May 2018

Ethics approval and consent to participate

: This study will be carried out in accordance with the principles of the Declaration of Helsinki and in compliance with Good Clinical Practice. The study protocol was approved on March 14 2017 by the Ethics Committee of the Erasmus MC Rotterdam in the Netherlands (MEC2016–719). Secondary approval from local boards is obtained before initiation in each participating center. Any substantial amendments to the original study dossier will be submitted for approval to the Ethics Committee in line with regulatory requirements. So far, five substantial amendments have been submitted and approved. In the first amendment generalized peritonitis was discarded as an exclusion criterion (in the original protocol) and the definition of adverse events was narrowed to events related to the experimental treatment. In the second amendment, ceftriaxone-metronidazole was incorporated in the protocol as an alternative to cefuroxime-metronidazole and gentamicin was approved as co-intervention. Moreover, in all five amendments participating centers were added, to add up to 14 participating centers in total.Eligible patients will receive detailed information regarding the trial, both orally and in writing (Additional file). Written informed consent will be obtained from all participants by surgeons and surgical residents from the participating centers. All participants are protected by the liability insurance of the Erasmus MC that is in accordance with the legal requirements in the Netherlands. Data will be handled confidentially and anonymously. Upon inclusion into this study, each patient will be assigned a study number. The key to the code, a subject identification code list, will be stored separately safeguarded by the local investigator. The code will not be based on the patient’s initials or birth date. Only involved investigators will have access to the data. The handling of personal data is in compliance with the Dutch Personal Data Protection Act (in Dutch: De Wet Bescherming Persoonsgegevens, Wbp). The results of the present study will be disseminated through publication in a general medical or surgical journal and presentation at international conferences.

: The authors declare that they have no competing interests.

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