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.
Patient aged 18 years and older
Colectomy for cancer
Pancreatectomy for cancer
Hepatectomy for cancer
Patient already participating in an interventional clinical trial
Adult patient subject to a legal protection measure, guardianship, or deprived of liberty by a judicial or administrative decision
Patient unable to complete a questionnaire and without a close caregiver to support the use of the solution
Patient with a psychiatric disorder that would prevent them from giving informed consent or receiving optimal treatment and follow-up
Sequential
MAELA
DevicePatients 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
Evaluate the clinical effectiveness of the Maela® medical remote monitoring device after scheduled digestive oncology surgery compared to conventional management
Presence/absence at day 90 post-surgery defined as the composite of : * A grade III to IV complication according to the Clavien-Dindo classification AND/OR * A post-operative readmission related to surgery (defined by an unscheduled readmission and/or a visit to the emergency room).
Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Presence of at least one grade III to IV complication according to the Clavien-Dindo scale at Day 30 and day 90 post-surgery
Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Number of postoperative readmissions related to surgery (defined by an unscheduled readmission and/or a visit to the emergency room) at Day 30 and day 90 post-surgery
Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Number of postoperative complications according to grade according to the Clavien-Dindo classification at Day 30 and day 90 post-surgery
Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Number of prolonged hospital stays defined as the 75th percentile of the initial length of stay in hospitalized patients at Day 30 and day 90 post-surgery
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
Hôpital Lariboisière Fernand Widal
Collaborator
Hotel Dieu Hospital
Collaborator
MN Santé
Collaborator
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