An Evaluation of Multisense® to Ensure a Safe Return Home Following High-risk Gastrointestinal Surgery, Compared With Standard Care.

SENSE-ECO study is a prospective, multicenter, randomized open-label trial designed to evaluate the clinical and medico-economic impact of the MultiSense® remote monitoring solution for 490 high-risk patients (ASA 2 or 3) undergoing major digestive surgery. The primary objective is to demonstrate that using this Class IIa wearable patch to monitor vital signs-such as heart rate, $SpO\_2$, and respiratory rate-allows for a reduced initial hospital stay without increasing 30-day morbidity compared to standard care. In the experimental group, patients are equipped with the device 12 to 24 hours before discharge to continue continuous home monitoring for five days, while the study also assesses secondary factors including cost-effectiveness for the French healthcare system, patient quality of life via the fQoR-15 questionnaire, and organizational workload for medical staff. Conducted across five centers under the coordination of Dr. Ugo Marchese.

• Average CCI score from the Detailed Complications Index, calculated based on complications recorded according to the Clavien-Dindo classification over 8days, 15days, 30days and 90days post-surgery for each of the two groups: MultiSense® grp & Standad grp [Срок оценки: 8days, 15days, 30days and 90days]
• Average number of deaths in each arm over 8 days, 15 days, 30 days and 90 days [Срок оценки: 8 days, 15 days, 30 days and 90 days]
• Average total cumulative length of stay over 30 days [Срок оценки: 30 days]
• Average number of hospital readmissions among patients receiving MultiSense® compared with patients receiving standard care, over a 30 days period; severity of the patient at readmission assessed using the Clavien-Dindo classification [Срок оценки: 30 days]
• Patient quality of life scores assessed at baseline, on discharge from hospital and at 30 days using the fQoR-15 questionnaire [Срок оценки: 30 days]
• Total 30-day healthcare costs (€) and cost-effectiveness comparing outcome differences between groups, including morbidity, length of stay, readmissions, patient severity, staff satisfaction, quality of life, and organisational impact. [Срок оценки: 30 days]
• Net benefit to the healthcare system (€) from the roll-out of the Multisense solution in France (difference between incurred and avoided costs) over 4 years [Срок оценки: 4 years]
• Average daily time (hours and minutes) spent on the platform by the remote monitoring team to monitor patients in the MultiSense group (collected via the MultiSense platform) [Срок оценки: Daily during the 5 days remote monitoring period following hospital discharge]
• Average number of incoming and outgoing calls per patient in both groups within 30 days of surgery [Срок оценки: 30 days]
• Table of activities and stakeholders enabling a comprehensive identification of the roles of the various parties involved in post-operative monitoring within each group [Срок оценки: Up to 30 days post-surgery]
• Levels of satisfaction 30 days post-operation, as reported by healthcare professionals (surgeons and paramedical staff involved in patient follow-up) and by patients, assessed using ad hoc questionnaires designed for the study [Срок оценки: 30 day]
• Assessment of the usability of the MultiSense® solution for healthcare professionals involved in post-operative follow-up, using the F-SUS scale completed at the end of the study [Срок оценки: 18 months]