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

Assistance Publique - Hôpitaux de Paris

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Digestive Cancers

MAELADEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

CH Sud Francilien

Corbeil-Essonnes, France

Hôpital Nord

Marseille, France

CHRU Nancy Brabois

Nancy, France

Hôpital Saint-Antoine

Paris, France

CHU Rouen

Rouen, France

Outcomes

Primary Outcomes

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 : * 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).

Time frame: Day 90 post-surgery

Secondary Outcomes

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

Time frame: 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 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Day 90 post-surgery

Evaluate the medical and economic benefit of patient monitoring with the Maela® solution

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Data from ClinicalTrials.gov

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

Overview

Conditions

Interventions

Eligibility

Locations (5)

Outcomes

Primary Outcomes

Secondary Outcomes