Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery (CONTACT-GRECCAR 21)
NCT ID: NCT06850688
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
362 participants
INTERVENTIONAL
2025-06-17
2026-10-17
Brief Summary
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Participants will be randomized into either the "30 days of remote monitoring" group or the "conventional discharge" group. The patient returns to the site for their postoperative visit at 30 days and is contacted by phone 90 days after their surgery.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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conventional discharge
The patients will be discharged from the hospital through standard discharge procedures. They will be seen on Day 30 during their routine postoperative consultation and then contacted by phone on Day 90. All patients will be required to complete a patient diary from Day 0 to the telephone contact on Day 90 in order to record their healthcare utilization during this period.
No interventions assigned to this group
Remote monitoring plateform
Patient monitoring via the remote monitoring platform for 30 days after hospital discharge. They will be seen on Day 30 during their routine postoperative consultation and then contacted by phone on Day 90. All patients will be required to complete a patient diary from Day 0 to the telephone contact on Day 90 in order to record their healthcare utilization during this period.
The qualitative component includes data collection through semi-structured individual interviews with a sample of patients, as well as data collection through focus groups with a sample of healthcare professionals involved in the system.
Remote monitoring platform
EPOCA Intelligence Information System is a remote monitoring plateform. The medical device is used as a SaaS platform with restricted access for healthcare professionals. Patients and their families interact with the medical device via notifications and secure links, upon request. The medical device integrates the use of other medical devices such as oximeters, blood pressure monitors, glucometers, bracelets, etc., which are connected and whose use is also governed by their user manuals and training.
Patient is monitoring via the remote monitoring platform for 30 days after hospital discharge
Interventions
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Remote monitoring platform
EPOCA Intelligence Information System is a remote monitoring plateform. The medical device is used as a SaaS platform with restricted access for healthcare professionals. Patients and their families interact with the medical device via notifications and secure links, upon request. The medical device integrates the use of other medical devices such as oximeters, blood pressure monitors, glucometers, bracelets, etc., which are connected and whose use is also governed by their user manuals and training.
Patient is monitoring via the remote monitoring platform for 30 days after hospital discharge
Eligibility Criteria
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Inclusion Criteria
* Patient who has undergone colorectal surgery not managed on an outpatient basis at the investigator center,
* At least one of the following two criteria:
* Anticipated early discharge (within 24 hours following laparoscopic surgery without diversion and within 5 days following surgery by laparotomy with stoma) for a surgery not managed on an outpatient basis in routine practice,
* Estimated risk of hospital readmission greater than 10% according to the nomogram of Tevis et al. \[15\], adapted to the postoperative context in digestive surgery (\>120 points according to this score).
* Patient affiliated with a health insurance plan,
* Patient who has signed the study consent form.
Exclusion Criteria
* Condition managed on an outpatient basis in routine practice for this type of patient,
* Patient eligible for home hospitalization services,
* Suicidal or hetero-aggressive risk in a patient living alone at home
* Homeless patient,
* Pregnant or breastfeeding women,
* Patient under legal guardianship, curatorship, or protected legal status,
* Patient already enrolled in an interventional postoperative follow-up study.
18 Years
ALL
No
Sponsors
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EPOCA U&I
INDUSTRY
Ministry of Health, France
OTHER_GOV
Nantes University Hospital
OTHER
Responsible Party
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Locations
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CHRU Tours
Tours, , France
CHU Angers
Angers, , France
Clinique Tivoli- Ducos
Bordeaux, , France
CHU Grenoble
Grenoble, , France
Centre Hospitalier Lyon-Sud
Lyon, , France
CHU Timone - Assistance publique-Hôpitaux de Marseille
Marseille, , France
Hôpital Nord - Assistance publique- Hôpitaux de Marseille
Marseille, , France
Institut Paoli Calmettes
Marseille, , France
CHU Nantes
Nantes, , France
Hôpital de Bicêtre - Assistance Publique Hôpitaux de Paris
Paris, , France
Hôpital Saint Antoine - Assistance publique - Hôpitaux de Paris
Paris, , France
CHU Rennes
Rennes, , France
Clinique Mutualiste de l'estuaire
Saint-Nazaire, , France
CHU Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-A01770-47
Identifier Type: REGISTRY
Identifier Source: secondary_id
RC22_0452
Identifier Type: -
Identifier Source: org_study_id
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