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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Digestive Cancers
• Intervention / Treatment: Device: MAELA

• Study Type: Interventional
• Enrollment (Estimated): 555
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ugo Marchese, MD; Phone Number: +33158413903; Email: ugo.marchese@aphp.fr

Study Locations

• France
  • Corbeil-Essonnes, France, 91100
    • Ch Sud Francilien
    • Contact: Jan Martin Proske, MD; Phone Number: +33161697825; Email: jm.proske@chsf.fr
  • Marseille, France, 13015
    • Hopital Nord
    • Contact: David Birnbaum, MD; Phone Number: +33491965090; Email: david.birnbaum@ap-hm.fr
  • Nancy, France, 54500
    • CHRU Nancy Brabois
    • Contact: Ahmet Ayav, MD; Phone Number: +33383154207; Email: a.ayav@chru-nancy.fr
  • Paris, France, 75012
    • Hôpital Saint-Antoine
    • Contact: Jérémie Lefevre, MD; Phone Number: +33171970419; Email: jeremie.lefevre@aphp.fr
  • Rouen, France, 76000
    • CHU Rouen
    • Contact: Lilian Schwarz, MD; Phone Number: +33232888416; Email: lilian.schwarz@chu-rouen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MAELA; Patients will benefit from the Maela® solution from the surgical scheduling visit until 90 days (+/- 15 days) following surgery	Device: MAELA; 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
No Intervention: Standard of care; Control group without remote monitoring and following standard monitoring according to the conventional care pathway

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	Change in pain intensity on Day 1 (24 hours post-surgery) assessed by the VAS scale (0-10) at Day 30 and day 90 post-surgery	Day 1 (24 hours), Day 30 and day 90 post-surgery
Evaluate the impact of remote monitoring using the Maela® solution on patients' quality of life	Change in quality-of-life score using the EORTC QLQ C30 questionnaire at inclusion, D30 and D90	D0, Day 30 and day 90 post-surgery
Evaluate the impact of remote monitoring using the Maela® solution on patients' quality of life	Change in postoperative recovery quality score using the QoR-15 scale (0-10) at D1 (24 hours post-surgery), D30 and D90	D1 (24hours), Day 30 and Day 90 post-surgery
Assess the organizational impact linked to the deployment of the Maela® solution according to the HAS mapping	Number of days spent outside the hospital (initial hospitalization and re-hospitalization) within 90 days following surgery	Day 90 post-surgery
Assess the organizational impact linked to the deployment of the Maela® solution according to the HAS mapping	Number of unscheduled consultations without hospitalization and related to surgery (with a general practitioner or surgeon) within 90 days following surgery	Day 90 post-surgery
Evaluate the medical and economic benefit of patient monitoring with the Maela® solution	Evaluate the medical and economic benefit of patient monitoring with the Maela® solution	Day 90 post-surgery
Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group	Monthly compliance rate for remote monitoring at D30 and D90, defined by the formula: Compliance rate = (Number of completed questionnaires / Total number of questionnaires) x 100	Day 30 and day 90 post-surgery
Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group	Average alert management time, defined by the time between alert issuance and resolution at D90	Day 90 post-surgery
Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group	Usability assessed by the French version of the SUS (System Usability Scale) questionnaire by patients at D90	Day 90 post-surgery
Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group	Patient satisfaction assessed by a specific qualitative questionnaire completed at D90	Day 90 post-surgery
Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group	Healthcare professional satisfaction assessed by a specific qualitative questionnaire completed at the end of each period (control and intervention)	At the end of the control period (Month 1 to Month 6, depending of the time the intervention begin) and at the end of the interventionnal period (Month 12) for each center

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Hotel Dieu Hospital; Hôpital Lariboisière Fernand Widal; MN Santé

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Surgery; remote monitoring; digestive cancer; post-operative complication
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: APHP241518

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No