148 Chapter 7 patient-centred app can significantly increase compliance with the active elements of the ERAS protocol in patients undergoing colorectal surgery. METHOD Study design The ERAS APPtimize study is a multicentre RCT that was conducted between October 2019 and September 2022 at one academic hospital and four teaching hospitals in the Netherlands. The ERAS protocol was implemented into the care pathways of all centres, initiated at varying time points and accompanied by locally different adaptations. The study was approved by the local medical ethics committee of Amsterdam UMC (registration number NL63874.018.17). The study protocol has been previously published.27 The trial was prospectively registered on International Clinical Trial Registry Platform (ICTRP); registration number NTR7314. The study is reported according CONSORT-EHEALTH(Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and online TeleHealth) checklist and the Reporting on ERAS Compliance, Outcomes, and Elements Research (RECOvER) Checklist.28,29 Study population Patients were eligible if they underwent elective colorectal surgery for either malignant or benign disease, were aged 18 years or older, and were in possession of a smartphone running at least the operating systems iOS 9 or Android 8.0. Patients were excluded if they met any of the following criteria: • Palliative surgery or surgery performed after neoadjuvant radiotherapy or chemotherapy • Karnofsky Performance score ≤40 • Inability to understand the Dutch language • Visual impairment, unless well corrected with visual aids • Limitations in using mobile applications due to physical or mental impairments, • Wheelchair-restricted • Estimated pre-operatively if post-operative adherence to the ERAS protocol is not feasible • Resection of multiple organs Group allocation and blinding After informed consent, patients were randomly assigned (1:1) using internet block randomization with block sizes of two, four, and six to either the intervention or the control group. Randomization was stratified by disease (benign and malignant) and age
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