Evaluation of the Clinical Impact of the Numerique Medical Device MAELA® Ont the Care Pathway in Digestive Oncology Surgery

In France, digestive cancers are responsible for more than 40,000 deaths per year, or approximately 30% of cancer-related deaths. Surgery is central to the patient's journey, particularly their treatment, and postoperative complications, whether cardiovascular, respiratory, infectious, thromboembolic, or related to postoperative pain, remain common and can have a significant impact on patients' quality of life and long-term outcomes. The implementation of continuous monitoring contributes to optimizing the care pathway and is necessary to improve postoperative outcomes. Postoperatively, remote monitoring has proven its effectiveness in significantly reducing postoperative readmission rates, particularly among patients who have undergone colorectal surgery. It allows for rapid intervention in the event of frequent complications, thus preventing unnecessary hospitalizations. To date, no study has evaluated the efficacy and safety of such a remote monitoring tool compared to conventional management on the clinical and organizational consequences postoperatively. Maela® is an app that allows patients to complete a symptom tracking questionnaire using a mobile device for 90 days following surgery. Surgeons can track new alerts via the solution's web interface. The primary objective of the study is to evaluate the clinical efficacy of the Maela® medical remote monitoring device after elective digestive oncology surgery compared to conventional management.

NCT Number	NCT07558330
Lead Sponsor	Assistance Publique - Hôpitaux de Paris Collaborators: Hôpital Lariboisière Fernand Widal, Hotel Dieu Hospital, MN Santé
Conditions	Digestive Cancers
Start Date	2026-11-01
Primary Completion	2027-11-01 (estimated)
Study Completion	2027-11-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-06