Evaluation of the Clinical Impact of the Numerique Medical Device MAELA® Ont the Care Pathway in Digestive Oncology Surgery (CODAP)
2 de julho de 2026 atualizado 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.
Visão geral do estudo
Tipo de estudo
Intervencional
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Corbeil-Essonnes, França, 91100
- Ch Sud Francilien
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Marseille, França, 13015
- Hôpital Nord
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Nancy, França, 54500
- CHRU Nancy Brabois
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Paris, França, 75012
- Hôpital Saint-Antoine
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Rouen, França, 76000
- CHU Rouen
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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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Sem intervenção: Standard of care
Control group without remote monitoring and following standard monitoring according to the conventional care pathway
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Evaluate the clinical effectiveness of the Maela® medical remote monitoring device after scheduled digestive oncology surgery compared to conventional management
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de novembro de 2026
Conclusão Primária (Estimado)
1 de novembro de 2027
Conclusão do estudo (Estimado)
1 de novembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
12 de março de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de abril de 2026
Primeira postagem (Real)
30 de abril de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
6 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- APHP241518
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