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

23. April 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

555

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Frankreich
      • Corbeil-Essonnes, Frankreich, 91100
        • CH Sud Francilien
        • Kontakt:
      • Marseille, Frankreich, 13015
      • Nancy, Frankreich, 54500
        • Chru Nancy Brabois
        • Kontakt:
      • Paris, Frankreich, 75012
      • Rouen, Frankreich, 76000

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: MAELA
Patients will benefit from the Maela® solution from the surgical scheduling visit until 90 days (+/- 15 days) following surgery
Gerät: 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
Kein Eingriff: Standard of care
Control group without remote monitoring and following standard monitoring according to the conventional care pathway

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Evaluate the clinical effectiveness of the Maela® medical remote monitoring device after scheduled digestive oncology surgery compared to conventional management
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Assistance Publique - Hôpitaux de Paris

Mitarbeiter

Hotel Dieu Hospital
Hôpital Lariboisière Fernand Widal
MN Santé

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. November 2026

Primärer Abschluss (Geschätzt)

1. November 2027

Studienabschluss (Geschätzt)

1. November 2027

Studienanmeldedaten

Zuerst eingereicht

12. März 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. April 2026

Zuerst gepostet (Tatsächlich)

30. April 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. April 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • APHP241518

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Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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