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

NCT07558330 | Not Yet Recruiting

• 1 other identifier: APHP241518
• Study Type: interventional
• Target: 555
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Digestive Cancers

Keywords

digestive cancer; Surgery; post-operative complication; remote monitoring

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 90 post-surgery

Secondary Outcomes (15)

• Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery

  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

  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

  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

  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

  Day 1 (24 hours), Day 30 and day 90 post-surgery

Study Arms (2)

MAELA

EXPERIMENTAL

Patients will benefit from the Maela® solution from the surgical scheduling visit until 90 days (+/- 15 days) following surgery

Device: MAELA

Standard of care

NO INTERVENTION

Control group without remote monitoring and following standard monitoring according to the conventional care pathway

Interventions

MAELA DEVICE

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

MAELA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18 years and older
• Patient scheduled for digestive oncology surgery:
• Colectomy for cancer
• Pancreatectomy for cancer
• Hepatectomy for cancer
• Proctectomy for cancer
• Gastrectomy for cancer
• Esophagectomy for cancer
• At least 2 weeks between scheduling and surgery
• 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
• Subject affiliated with or beneficiary of a health insurance plan
• Subject who can read and understand French
• Subject who has signed informed consent

You may not qualify if:

• 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
• Minor patient
• Visually impaired patient
• Patient with significant psychomotor disorders of the upper limbs
• Patient with memory disorders
• Patient without a mobile phone number
• Patient without internet access
• Pregnant or breastfeeding woman

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Hôpital Lariboisière Fernand Widal: collaborator
• Hotel Dieu Hospital: collaborator
• MN Santé: collaborator

Study Sites (5)

CH Sud Francilien

Corbeil-Essonnes, 91100, France

Location

Hôpital Nord

Marseille, 13015, France

Location

CHRU Nancy Brabois

Nancy, 54500, France

Location

Hôpital Saint-Antoine

Paris, 75012, France

Location

CHU Rouen

Rouen, 76000, France

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Central Study Contacts

Ugo Marchese, MD

CONTACT

+33158413903; ugo.marchese@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicenter, national, prospective, open-label, controlled, and randomized clinical superiority study conducted at the Stepped Wedge Cluster Randomized Trial (SWT): * Control period: conventional care pathway in accordance with each center's usual management. * Intervention period: care pathway managed by the Maela® solution. Patients will benefit from the Maela® solution from the surgical scheduling visit until 90 days (+/- 15 days) following surgery.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

FR (5)