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

2026年7月2日 更新者：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.

研究概览

地位

撤销

条件

干预/治疗

研究类型

介入性

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 法国
      • Corbeil-Essonnes、法国、91100
        • Ch Sud Francilien
      • Marseille、法国、13015
        • Hôpital Nord
      • Nancy、法国、54500
        • CHRU Nancy Brabois
      • Paris、法国、75012
        • Hôpital Saint-Antoine
      • Rouen、法国、76000
        • CHU Rouen

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：MAELA
Patients will benefit from the Maela® solution from the surgical scheduling visit until 90 days (+/- 15 days) following surgery
设备：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
无干预：Standard of care
Control group without remote monitoring and following standard monitoring according to the conventional care pathway

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Evaluate the clinical effectiveness of the Maela® medical remote monitoring device after scheduled digestive oncology surgery compared to conventional management
大体时间：Day 90 post-surgery

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

次要结果测量

结果测量
措施说明
大体时间
Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
大体时间：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
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
大体时间：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
Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
大体时间：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
大体时间：Day 30 and day 90 post-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
大体时间：Day 1 (24 hours), Day 30 and day 90 post-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
大体时间：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
D0, Day 30 and day 90 post-surgery
Evaluate the impact of remote monitoring using the Maela® solution on patients' quality of life
大体时间：D1 (24hours), Day 30 and Day 90 post-surgery
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
大体时间：Day 90 post-surgery
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
大体时间：Day 90 post-surgery
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
大体时间：Day 90 post-surgery
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
大体时间：Day 30 and day 90 post-surgery
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
大体时间：Day 90 post-surgery
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
大体时间：Day 90 post-surgery
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
大体时间：Day 90 post-surgery
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
大体时间：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
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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Assistance Publique - Hôpitaux de Paris

合作者

Hotel Dieu Hospital
Hôpital Lariboisière Fernand Widal
MN Santé

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2027年11月1日

研究完成 (估计的)

2027年11月1日

研究注册日期

首次提交

2026年3月12日

首先提交符合 QC 标准的

2026年4月23日

首次发布 (实际的)

2026年4月30日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年7月2日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • APHP241518

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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