Clinical trial NCT06850688: Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery (CONTACT-GRECCAR 21)
Official title: Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery - a Multicenter Randomized Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Surgery
Readmission
Keywords: colorectal surgery
remote monitoring platform
Hospital length of stay
Rehospitalization
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: EPOCA U&I
name: Ministry of Health, France
First posted: 2025-02-27
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 criteria: Inclusion Criteria :

* Man or woman over 18 years old at the time of the J0 visit,
* 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:

* 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.

Primary outcomes:
measure: Hospitalization days
timeFrame: 90 days
Secondary outcomes:
measure: Unplanned hospital readmission
timeFrame: 90 days
measure: Difference between the initial hospital discharge date and the hospital readmission date
timeFrame: 90 days
measure: Unplanned consultations
timeFrame: 90 days
measure: Postoperative morbidity
timeFrame: 90 days
measure: Severe postoperative morbidity
timeFrame: 90 days
measure: Visual Analog Scale at Day 3 for preoperative inclusions
timeFrame: Day 3
measure: Visual Analog Scale at Day 5 for preoperative inclusions
timeFrame: Day 5
measure: Rate of postoperative ileus at Day 3 for preoperative inclusions
timeFrame: Day 3
measure: Rate of postoperative ileus at Day 5 for preoperative inclusions
timeFrame: Day 5
measure: Return to Professional activities
timeFrame: 90 days
measure: Quality of life questionnaires "Medical Outcomes Study 36-item Short-Form Health Survey"
timeFrame: 30 days
measure: Quality of life questionnaires "Medical Outcomes Study 36-item Short-Form Health Survey"
timeFrame: 90 days
measure: Quality of life questionnaires EQ-5D
timeFrame: 30 days
measure: Quality of life questionnaires EQ-5D
timeFrame: 90 days
measure: Total cost of the care pathway over 90 days
timeFrame: 90 days
measure: Patient satisfaction
timeFrame: 30 days
measure: Number of days between surgery and the resumption of both gaseous and fecal transit within 90 days
timeFrame: 90 days
measure: Number of patients maintained at home but discontinuing the use of the remote monitoring platform system before the end of follow-up
timeFrame: 90 days
measure: The reason for patients remaining at home after discontinuing the use of the remote monitoring platform system before the end of the follow-up
timeFrame: 90 days
measure: Number of patients managed with the remote monitoring platform system
timeFrame: 90 days
measure: Duration of use of remote monitoring plateform
timeFrame: 90 days
measure: Characteristics of the care provided by the remote monitoring platform system
timeFrame: 90 days
measure: Focus groups
timeFrame: 90 days
measure: Patient and caregiver verbatims
timeFrame: 90 days
measure: Patient verbatims on the post-operative experience
timeFrame: 90 days
measure: Healthcare professionals' verbatims
timeFrame: 90 days
measure: Medical-economic endpoint
timeFrame: 90 days
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Bordeaux
country: France
facility: Clinique Tivoli- Ducos
city: Grenoble
country: France
facility: CHU Grenoble
city: Lyon
country: France
facility: Centre Hospitalier Lyon-Sud
city: Marseille
country: France
facility: CHU Timone - Assistance publique-Hôpitaux de Marseille
city: Marseille
country: France
facility: Hôpital Nord - Assistance publique- Hôpitaux de Marseille
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Hôpital de Bicêtre - Assistance Publique Hôpitaux de Paris
city: Paris
country: France
facility: Hôpital Saint Antoine - Assistance publique - Hôpitaux de Paris
city: Rennes
country: France
facility: CHU Rennes
city: Saint Nazaire
country: France
facility: Clinique Mutualiste de l'estuaire
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHRU Tours
Study officials:
References: