Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery (CONTACT-GRECCAR 21)
Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery - A Multicenter Randomized Study
Nantes University Hospital
362 participants
Jun 17, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this Clinical Investigation is to evaluate the effectiveness of implementing the discharge protocol of the remote monitoring platform after colorectal surgery in patients at risk of hospital readmission. 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.
Eligibility
Inclusion Criteria7
- Man or woman over 18 years old at the time of the J0 visit,
- Patient who underwent surgery less than 28 days ago, or who is scheduled to undergo colorectal surgery not managed as an outpatient procedure at the investigational center, including resection of at least one colonic or rectal segment and/or an anastomosis involving the colon or rectum,
- At least one of the following two criteria:
- Anticipated early discharge (within 24 hours following laparoscopic surgery without stoma and without diversion, and within 5 days following laparotomy and/or surgery with stoma and/or rectal surgery) for a procedure that is not usually managed as an outpatient surgery 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 Criteria8
- Discharge to a rehabilitation center requested by the patient,
- 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.
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Interventions
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
Locations(14)
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NCT06850688