Evaluation of the Clinical Impact of the Numerique Medical Device MAELA® Ont the Care Pathway in Digestive Oncology Surgery (CODAP)
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.
調査の概要
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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Corbeil-Essonnes、フランス、91100
- Ch Sud Francilien
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Marseille、フランス、13015
- Hôpital Nord
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Nancy、フランス、54500
- CHRU Nancy Brabois
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Paris、フランス、75012
- Hôpital Saint-Antoine
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Rouen、フランス、76000
- CHU Rouen
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：Standard of care
Control group without remote monitoring and following standard monitoring according to the conventional care pathway
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Evaluate the clinical effectiveness of the Maela® medical remote monitoring device after scheduled digestive oncology surgery compared to conventional management
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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