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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 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

555

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Corbeil-Essonnes, Frankrig, 91100
        • Ch Sud Francilien
        • Kontakt:
      • Marseille, Frankrig, 13015
      • Nancy, Frankrig, 54500
        • CHRU Nancy Brabois
        • Kontakt:
      • Paris, Frankrig, 75012
      • Rouen, Frankrig, 76000

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: MAELA
Patients will benefit from the Maela® solution from the surgical scheduling visit until 90 days (+/- 15 days) following surgery
Enhed: 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
Ingen indgriben: Standard of care
Control group without remote monitoring and following standard monitoring according to the conventional care pathway

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluate the clinical effectiveness of the Maela® medical remote monitoring device after scheduled digestive oncology surgery compared to conventional management
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Assistance Publique - Hôpitaux de Paris

Samarbejdspartnere

Hotel Dieu Hospital
Hôpital Lariboisière Fernand Widal
MN Santé

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

1. november 2027

Studieafslutning (Anslået)

1. november 2027

Datoer for studieregistrering

Først indsendt

12. marts 2026

Først indsendt, der opfyldte QC-kriterier

23. april 2026

Først opslået (Faktiske)

30. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. april 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • APHP241518

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