About this trial
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.
Eligibility criteria
Qualifiers
Patient aged 18 years and older
Colectomy for cancer
Pancreatectomy for cancer
Hepatectomy for cancer
Disqualifiers
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
Trial design
Treatments tested in this trial
- MAELA
Treatment groups
Sponsors and collaborators
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Hôpital Lariboisière Fernand Widal
Collaborator
Hotel Dieu Hospital
Collaborator
MN Santé
Collaborator