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

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.

Inclusion Criteria:

1. Patient aged 18 years and older

2. Patient scheduled for digestive oncology surgery:

   1. Colectomy for cancer
   2. Pancreatectomy for cancer
   3. Hepatectomy for cancer
   4. Proctectomy for cancer
   5. Gastrectomy for cancer
   6. Esophagectomy for cancer

3. At least 2 weeks between scheduling and surgery

4. Patient with a smartphone (iOS or Android environment), or living with family members/primary caregivers who have a smartphone with access to cellular data/Wi-Fi

5. Subject affiliated with or beneficiary of a health insurance plan

6. Subject who can read and understand French

7. Subject who has signed informed consent

Exclusion Criteria:

1. Patient already participating in an interventional clinical trial
2. Adult patient subject to a legal protection measure, guardianship, or deprived of liberty by a judicial or administrative decision
3. Patient unable to complete a questionnaire and without a close caregiver to support the use of the solution
4. Patient with a psychiatric disorder that would prevent them from giving informed consent or receiving optimal treatment and follow-up
5. Minor patient
6. Visually impaired patient
7. Patient with significant psychomotor disorders of the upper limbs
8. Patient with memory disorders
9. Patient without a mobile phone number
10. Patient without internet access
11. Pregnant or breastfeeding woman