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Inability to complete the study within the alloted time
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| Name | Class |
|---|---|
| Hôpital Lariboisière Fernand Widal | OTHER |
| Hotel Dieu Hospital | OTHER |
| MN Santé | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAELA | Experimental | Patients will benefit from the Maela® solution from the surgical scheduling visit until 90 days (+/- 15 days) following surgery |
|
| Standard of care | No Intervention | Control group without remote monitoring and following standard monitoring according to the conventional care pathway |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAELA | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the clinical effectiveness of the Maela® medical remote monitoring device after scheduled digestive oncology surgery compared to conventional management | Presence/absence at day 90 post-surgery defined as the composite of :
| Day 90 post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive 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 |
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Inclusion Criteria:
Patient aged 18 years and older
Patient scheduled for digestive oncology surgery:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Sud Francilien | Corbeil-Essonnes | 91100 | France | |||
| Hôpital Nord |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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This is a multicenter, national, prospective, open-label, controlled, and randomized clinical superiority study conducted at the Stepped Wedge Cluster Randomized Trial (SWT):
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|
| Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Marseille |
| 13015 |
| France |
| CHRU Nancy Brabois | Nancy | 54500 | France |
| Hôpital Saint-Antoine | Paris | 75012 | France |
| CHU Rouen | Rouen | 76000 | France |
| D005767 |
| Gastrointestinal Diseases |