Evaluation of the Clinical Impact of the Numerique Medical Device MAELA® Ont the Care Pathway in Digestive Oncology Surgery (CODAP)
2 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Tipo de estudio
Intervencionista
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Corbeil-Essonnes, Francia, 91100
- Ch Sud Francilien
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Marseille, Francia, 13015
- Hôpital Nord
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Nancy, Francia, 54500
- CHRU Nancy Brabois
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Paris, Francia, 75012
- Hôpital Saint-Antoine
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Rouen, Francia, 76000
- CHU Rouen
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Sin intervención: Standard of care
Control group without remote monitoring and following standard monitoring according to the conventional care pathway
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Evaluate the clinical effectiveness of the Maela® medical remote monitoring device after scheduled digestive oncology surgery compared to conventional management
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Periodo de tiempo: Day 30 and day 90 post-surgery
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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
Periodo de tiempo: Day 30 and day 90 post-surgery
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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
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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
Periodo de tiempo: Day 30 and day 90 post-surgery
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Number of postoperative complications according to grade according to the Clavien-Dindo classification 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: D0, Day 30 and day 90 post-surgery
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
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Day 90 post-surgery
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Evaluate the medical and economic benefit of patient monitoring with the Maela® solution
Periodo de tiempo: Day 90 post-surgery
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Evaluate the medical and economic benefit of patient monitoring with the Maela® solution
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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
Periodo de tiempo: 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
Periodo de tiempo: Day 90 post-surgery
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Average alert management time, defined by the time between alert issuance and resolution 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
Periodo de tiempo: 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
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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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de noviembre de 2026
Finalización primaria (Estimado)
1 de noviembre de 2027
Finalización del estudio (Estimado)
1 de noviembre de 2027
Fechas de registro del estudio
Enviado por primera vez
12 de marzo de 2026
Primero enviado que cumplió con los criterios de control de calidad
23 de abril de 2026
Publicado por primera vez (Actual)
30 de abril de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- APHP241518
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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