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Evaluation of the Clinical Impact of the Numerique Medical Device MAELA® Ont the Care Pathway in Digestive Oncology Surgery
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
0
Start Date
2026-11-01
Completion Date
2027-11-01
Last Updated
2026-07-06
Healthy Volunteers
No
Conditions
Interventions
MAELA
Patients will benefit from the Maela® solution from the surgical scheduling visit until 90 days (+/- 15 days) following surgery. Maela will be use by patient to answer online questionnaire, which will generate alerts based on the responses. If an alert is generated, the surgeon or their nurse may see the patient early and adapt the care. The management will be at the discretion of the healthcare professionals
Locations (5)
CH Sud Francilien
Corbeil-Essonnes, France
Hôpital Nord
Marseille, France
CHRU Nancy Brabois
Nancy, France
Hôpital Saint-Antoine
Paris, France
CHU Rouen
Rouen, France