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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

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

555 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Hôpital Lariboisière Fernand Widal

Collaborator

Hotel Dieu Hospital

Collaborator

MN Santé

Collaborator