118 Chapter 5 2. Elective surgery that preoperatively was not expected to result in creation of a stoma, or stoma creation in emergency setting: From 12 h after surgery, the treating colorectal surgeon or supervised surgical assistant will explain the Stoma-APPtimize, if the patient is well awake and the clinical condition permits. If the patient is interested in participating in the trial, they will be given the Patient Information Form (PIF) and will be allowed at least 24 h to decide whether they want to participate. After providing written informed consent, patients are randomized to either the control group or the intervention group. Randomization and blinding After inclusion in the study, the participant will be added to the application system by the ostomy nurse or the coordinating researcher. The system generates a unique personal access code which also randomly allocates participants to either the intervention group or the control group. Allocation will be performed in a 1:1 ratio, with stratification according to indication for surgery (benign or malignant) and type of stoma (ileostomy and colostomy). Random block sizes of two, four and six will be used. Participants and healthcare providers will be blinded to the allocation outcomes. The coordinating researcher will provide instructions and is therefore unblinded. Participants will be instructed not to tell other participants or patients about the content of their version of the application. Data collection Data from the intervention and control groups will be mostly automatically collected and stored in a database. Self-reported questionnaires and reminder push notifications to fill them in will be sent automatically. Some data, such as baseline characteristics or clinical outcomes, will be retrieved from the electronic health record by the coordinating researcher and entered into electronic case report forms. Trial findings will be stored in accordance with local data protection regulations. A data protection impact assessment was included in the protocol. The following baseline characteristics will be collected preoperatively: sex, age, American Society of Anesthesiologists (ASA) classification, body mass index, alcohol intake, smoking, Karnofsky scores, operation indication, comorbidity and mobile device proficiency. Major per- and postoperative complications, prolonged hospital stay, readmission and comorbidities are considered as potential confounders. Healthcare personnel are instructed to register all potential confounders in the electronic health record. The coordinating researcher will screen potential confounders during follow-up of the participants.
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