Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery (CONTACT-GRECCAR 21)

NCT06850688 | Recruiting

• 2 other identifiers: RC22_04522024-A01770-47
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 14

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.

Conditions

Colorectal Surgery; Readmission

Keywords

colorectal surgery; remote monitoring platform; Hospital length of stay; Rehospitalization

Outcome Measures

Primary Outcomes (1)

• Hospitalization days

  Cumulative duration of hospitalization days up to 90 days after the index surgery

  90 days

Secondary Outcomes (27)

• Unplanned hospital readmission

  90 days

• Difference between the initial hospital discharge date and the hospital readmission date

  90 days

• Unplanned consultations

  90 days

• Severe postoperative morbidity

  90 days

• Visual Analog Scale at Day 3 for preoperative inclusions

  Day 3

Study Arms (2)

conventional discharge

NO INTERVENTION

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.

Remote monitoring plateform

EXPERIMENTAL

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.

Device: Remote monitoring platform

Interventions

Remote monitoring platform DEVICE

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

Remote monitoring plateform

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead
• EPOCA U&I: collaborator
• Ministry of Health, France: collaborator

Study Sites (14)

CHU Angers

Angers, France

RECRUITING

Clinique Tivoli- Ducos

Bordeaux, France

RECRUITING

CHU Grenoble

Grenoble, France

RECRUITING

Centre Hospitalier Lyon-Sud

Lyon, France

RECRUITING

CHU Timone - Assistance publique-Hôpitaux de Marseille

Marseille, France

RECRUITING

Hôpital Nord - Assistance publique- Hôpitaux de Marseille

Marseille, France

RECRUITING

Institut Paoli Calmettes

Marseille, France

NOT YET RECRUITING

CHU Nantes

Nantes, France

RECRUITING

Hôpital de Bicêtre - Assistance Publique Hôpitaux de Paris

Paris, France

RECRUITING

Hôpital Saint Antoine - Assistance publique - Hôpitaux de Paris

Paris, France

RECRUITING

CHU Rennes

Rennes, France

RECRUITING

Clinique Mutualiste de l'estuaire

Saint-Nazaire, France

RECRUITING

CHU Toulouse

Toulouse, France

RECRUITING

CHRU Tours

Tours, France

RECRUITING

Central Study Contacts

Emilie DUCHALAIS

CONTACT

+33 2 40 08 43 22; emilie.duchalais@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 27, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): May 17, 2027
• Study Completion (Estimated): May 17, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

FR (14)