Randomization and masking
RECRUITMENT
Patients will be enrolled in this trial by gastroenterologists, surgeons, and endoscopists who will evaluate the cases in inpatient wards and in outpatient consultation areas. Randomization will be performed through an electronic database upon inclusion in the study. A code list will be generated by randomization with a 1:1 randomization ratio, by blocks. Each subject will be assigned a randomization code along with the treatment that corresponds to it. Once the patient meets the eligibility criteria and has provided informed consent, we will proceed to the allocation of each participant, in a centralized way, ensuring allocation concealment, and based on the randomization list. To prevent different subject recruitment rates at the various hospitals from interfering with the development of the study, the entire population will be randomized in blocks of four and two between the two treatment possibilities.