Evaluation of the Clinical Impact of the Numerique Medical Device MAELA® Ont the Care Pathway in Digestive Oncology Surgery (CODAP)
2 juillet 2026 mis à jour par: Assistance Publique - Hôpitaux de Paris
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.
Aperçu de l'étude
Type d'étude
Interventionnel
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Corbeil-Essonnes, France, 91100
- Ch Sud Francilien
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Marseille, France, 13015
- Hôpital Nord
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Nancy, France, 54500
- CHRU Nancy Brabois
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Paris, France, 75012
- Hôpital Saint-Antoine
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Rouen, France, 76000
- CHU Rouen
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: MAELA
Patients will benefit from the Maela® solution from the surgical scheduling visit until 90 days (+/- 15 days) following surgery
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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 |
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Aucune intervention: Standard of care
Control group without remote monitoring and following standard monitoring according to the conventional care pathway
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Evaluate the clinical effectiveness of the Maela® medical remote monitoring device after scheduled digestive oncology surgery compared to conventional management
Délai: Day 90 post-surgery
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Presence/absence at day 90 post-surgery defined as the composite of :
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Day 90 post-surgery
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Délai: Day 30 and day 90 post-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
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Day 30 and day 90 post-surgery
|
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Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Délai: Day 30 and day 90 post-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
|
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Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Délai: Day 30 and day 90 post-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
Délai: Day 30 and day 90 post-surgery
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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
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Day 30 and day 90 post-surgery
|
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Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Délai: Day 1 (24 hours), Day 30 and day 90 post-surgery
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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
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Day 1 (24 hours), Day 30 and day 90 post-surgery
|
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Evaluate the impact of remote monitoring using the Maela® solution on patients' quality of life
Délai: D0, Day 30 and day 90 post-surgery
|
Change in quality-of-life score using the EORTC QLQ C30 questionnaire at inclusion, D30 and D90
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D0, Day 30 and day 90 post-surgery
|
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Evaluate the impact of remote monitoring using the Maela® solution on patients' quality of life
Délai: D1 (24hours), Day 30 and Day 90 post-surgery
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Change in postoperative recovery quality score using the QoR-15 scale (0-10) at D1 (24 hours post-surgery), D30 and D90
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D1 (24hours), Day 30 and Day 90 post-surgery
|
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Assess the organizational impact linked to the deployment of the Maela® solution according to the HAS mapping
Délai: Day 90 post-surgery
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Number of days spent outside the hospital (initial hospitalization and re-hospitalization) within 90 days following surgery
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Day 90 post-surgery
|
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Assess the organizational impact linked to the deployment of the Maela® solution according to the HAS mapping
Délai: Day 90 post-surgery
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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
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Evaluate the medical and economic benefit of patient monitoring with the Maela® solution
Délai: Day 90 post-surgery
|
Evaluate the medical and economic benefit of patient monitoring with the Maela® solution
|
Day 90 post-surgery
|
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Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group
Délai: Day 30 and day 90 post-surgery
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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
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Day 30 and day 90 post-surgery
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Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group
Délai: Day 90 post-surgery
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Average alert management time, defined by the time between alert issuance and resolution at D90
|
Day 90 post-surgery
|
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Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group
Délai: Day 90 post-surgery
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Usability assessed by the French version of the SUS (System Usability Scale) questionnaire by patients at D90
|
Day 90 post-surgery
|
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Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group
Délai: Day 90 post-surgery
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Patient satisfaction assessed by a specific qualitative questionnaire completed at D90
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Day 90 post-surgery
|
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Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group
Délai: 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
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Healthcare professional satisfaction assessed by a specific qualitative questionnaire completed at the end of each period (control and intervention)
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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
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 novembre 2026
Achèvement primaire (Estimé)
1 novembre 2027
Achèvement de l'étude (Estimé)
1 novembre 2027
Dates d'inscription aux études
Première soumission
12 mars 2026
Première soumission répondant aux critères de contrôle qualité
23 avril 2026
Première publication (Réel)
30 avril 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- APHP241518
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .