[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635872":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":104,"collaborators":106,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":18,"enrollmentInfo":123,"targetDuration":18,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":137,"whyStopped":18,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MAELA","EXPERIMENTAL","Patients will benefit from the Maela® solution from the surgical scheduling visit until 90 days (+\u002F- 15 days) following surgery",[13],"Device: MAELA",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care","NO_INTERVENTION","Control group without remote monitoring and following standard monitoring according to the conventional care pathway",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DEVICE","Patients will benefit from the Maela® solution from the surgical scheduling visit until 90 days (+\u002F- 15 days) following surgery.\n\nMaela will be use by patient to answer online questionnaire, which will generate alerts based on the responses.\n\nIf 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",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Ugo Marchese, MD","CONTACT","+33158413903","ugo.marchese@aphp.fr",[31,48,62,76,90],{"facility":32,"status":18,"city":33,"state":18,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"CH Sud Francilien","Corbeil-Essonnes","91100","France","FR",{"type":38,"coordinates":39},"Point",[40,41],2.48757,48.60603,{"lat":41,"lon":40},[44],{"name":45,"role":27,"phone":46,"phoneExt":18,"email":47},"Jan Martin Proske, MD","+33161697825","jm.proske@chsf.fr",{"facility":49,"status":18,"city":50,"state":18,"zip":51,"country":35,"countryCode":36,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Hôpital Nord","Marseille","13015",{"type":38,"coordinates":53},[54,55],5.38107,43.29695,{"lat":55,"lon":54},[58],{"name":59,"role":27,"phone":60,"phoneExt":18,"email":61},"David Birnbaum, MD","+33491965090","david.birnbaum@ap-hm.fr",{"facility":63,"status":18,"city":64,"state":18,"zip":65,"country":35,"countryCode":36,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"CHRU Nancy Brabois","Nancy","54500",{"type":38,"coordinates":67},[68,69],6.18496,48.68439,{"lat":69,"lon":68},[72],{"name":73,"role":27,"phone":74,"phoneExt":18,"email":75},"Ahmet Ayav, MD","+33383154207","a.ayav@chru-nancy.fr",{"facility":77,"status":18,"city":78,"state":18,"zip":79,"country":35,"countryCode":36,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Hôpital Saint-Antoine","Paris","75012",{"type":38,"coordinates":81},[82,83],2.3488,48.85341,{"lat":83,"lon":82},[86],{"name":87,"role":27,"phone":88,"phoneExt":18,"email":89},"Jérémie Lefevre, MD","+33171970419","jeremie.lefevre@aphp.fr",{"facility":91,"status":18,"city":92,"state":18,"zip":93,"country":35,"countryCode":36,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"CHU Rouen","Rouen","76000",{"type":38,"coordinates":95},[96,97],1.09932,49.44313,{"lat":97,"lon":96},[100],{"name":101,"role":27,"phone":102,"phoneExt":18,"email":103},"Lilian Schwarz, MD","+33232888416","lilian.schwarz@chu-rouen.fr",{"type":105,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[107,109,111],{"name":108,"class":6},"Hôpital Lariboisière Fernand Widal",{"name":110,"class":6},"Hotel Dieu Hospital",{"name":112,"class":113},"MN Santé","UNKNOWN","100635872","evaluation-of-the-clinical-impact-of-the-numerique-medical-device-maela-ont-the-care-pathway-in-digestive-oncology-surgery-100635872",false,"NCT07558330","Evaluation of the Clinical Impact of the Numerique Medical Device MAELA® Ont the Care Pathway in Digestive Oncology Surgery","CODAP","Inclusion Criteria:\n\n1. Patient aged 18 years and older\n2. Patient scheduled for digestive oncology surgery:\n\n   1. Colectomy for cancer\n   2. Pancreatectomy for cancer\n   3. Hepatectomy for cancer\n   4. Proctectomy for cancer\n   5. Gastrectomy for cancer\n   6. Esophagectomy for cancer\n3. At least 2 weeks between scheduling and surgery\n4. Patient with a smartphone (iOS or Android environment), or living with family members\u002Fprimary caregivers who have a smartphone with access to cellular data\u002FWi-Fi\n5. Subject affiliated with or beneficiary of a health insurance plan\n6. Subject who can read and understand French\n7. Subject who has signed informed consent\n\nExclusion Criteria:\n\n1. Patient already participating in an interventional clinical trial\n2. Adult patient subject to a legal protection measure, guardianship, or deprived of liberty by a judicial or administrative decision\n3. Patient unable to complete a questionnaire and without a close caregiver to support the use of the solution\n4. Patient with a psychiatric disorder that would prevent them from giving informed consent or receiving optimal treatment and follow-up\n5. Minor patient\n6. Visually impaired patient\n7. Patient with significant psychomotor disorders of the upper limbs\n8. Patient with memory disorders\n9. Patient without a mobile phone number\n10. Patient without internet access\n11. Pregnant or breastfeeding woman","ALL","18 Years",{"count":124,"type":125},555,"ESTIMATED","INTERVENTIONAL",[128],"NA","In France, digestive cancers are responsible for more than 40,000 deaths per year, or approximately 30% of cancer-related deaths.\n\nSurgery 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.\n\nThe implementation of continuous monitoring contributes to optimizing the care pathway and is necessary to improve postoperative outcomes.\n\nPostoperatively, remote monitoring has proven its effectiveness in significantly reducing postoperative readmission rates, particularly among patients who have undergone colorectal surgery.\n\nIt allows for rapid intervention in the event of frequent complications, thus preventing unnecessary hospitalizations.\n\nTo 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.\n\nMaela® 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.\n\nThe 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.",[131],"Digestive Cancers",[133,134,135,136],"digestive cancer","Surgery","post-operative complication","remote monitoring","NOT_YET_RECRUITING","2026-04-23",{"date":140,"type":141},"2026-04-30","ACTUAL",{"date":143,"type":125},"2026-11-01",{"date":145,"type":125},"2027-11-01",{"name":5,"class":6},5]