Evaluation of the Clinical Impact of the Numerique Medical Device MAELA® Ont the Care Pathway in Digestive Oncology Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 5
- 主要终点
- Evaluate the clinical effectiveness of the Maela® medical remote monitoring device after scheduled digestive oncology surgery compared to conventional management
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evaluate the clinical effectiveness of the Maela® medical remote monitoring device after scheduled digestive oncology surgery compared to conventional management
时间窗: 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).
次要结局
- Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive 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(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(D0, Day 30 and day 90 post-surgery)
- Evaluate the impact of remote monitoring using the Maela® solution on patients' quality of life(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(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(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(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(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)