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Article History

Received: 10 February 2022

Accepted: 11 May 2022

First Online: 26 May 2022

Declarations

:

: The study will be conducted in accordance with the Declaration of Helsinki and complies with current GDPR recommendations. The regional Danish Medical Ethics Committee has approved the study to include patients in the acute setting with temporary consent by a surgical equipoise followed by patient information and consent after recovery. The surgical equipoise must not have any personal interest in the experiment, experience, or know about the disease and the risks and benefits of the treatments. It must be indifferent to the therapeutic value of the two interventions. The rationale for choosing this inclusion model was that the subjects requiring immediate surgical intervention are partially or entirely incapable of receiving and understanding the information. The severity of the condition does not allow time for third-party authorisation. Both treatment regimens are accepted, safe, and widely used for this patient group. The COOL Investigators have made a comprehensive review of Surgical Ethics that further justifies the arguments for using consent by surgical equipoise []. After the convalescence, patients will be informed about the project, and consent will be obtained. Surrogate consent will be obtained when the patients do not survive before regaining a habitual state. The patient can withdraw from the experiment at any time without having to explain their reasons. To ensure patient safety, we will perform three interim analyses.Patients in Denmark are covered by national insurance (Patienterstatningen), and international centres use country-specific insurance regulations. The study is investigator-initiated without economic interest to manufacturers or others involved in the investigation. No financial resources will be provided to the trial participants. Participating centres will receive the amount of 4000 Danish Krone per included patient yearly to cover the CT-scan of the abdomen and follow-up at the outpatient clinic.The final data set will be available to the project owner and data assessor. Data can be shared in a pseudonymised form after an approved agreement on request. The primary investigator is responsible for data collection and handling. Protocol modifications must be reported to the regional ethics committee.

: Not applicable.

: The primary investigator and collaborators have no financial interest in the trial.