About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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,
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).
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Remote monitoring platform
DeviceEPOCA 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
Treatment groups
Trial outcomes
Primary outcomes
Hospitalization days
Cumulative duration of hospitalization days up to 90 days after the index surgery
Secondary outcomes
Unplanned hospital readmission
Rate of unplanned hospital readmissions with emergency department visits at 90 days
Difference between the initial hospital discharge date and the hospital readmission date
Difference between the initial hospital discharge date and the hospital readmission date (for readmitted patients)
Unplanned consultations
Rate of unplanned consultations at 90 days
Severe postoperative morbidity
Severe postoperative morbidity at 90 days (Clavien-Dindo classification levels 3 and 4)
Sponsors and contacts
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