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

Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery - A Multicenter Randomized Study

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Surgery; Readmission
• Intervention / Treatment: Device: Remote monitoring platform

• Study Type: Interventional
• Enrollment (Estimated): 362
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emilie DUCHALAIS; Phone Number: +33 2 40 08 43 22; Email: emilie.duchalais@chu-nantes.fr

Study Locations

• France
  • Angers, France
    • Recruiting
    • CHU Angers
    • Contact: Aurélien VENARA; Phone Number: +33 2 41 35 36 18; Email: AuVenara@chu-angers.fr
  • Bordeaux, France
    • Recruiting
    • Clinique Tivoli- Ducos
    • Contact: Quentin DENOST; Phone Number: 33 5 47 50 15 75; Email: q.denost@bordeaux-colorectal-institute.fr
  • Grenoble, France
    • Recruiting
    • CHU Grenoble
    • Contact: Bertrand TRILLING; Phone Number: +33 4 76 76 93 77; Email: btrilling@chu-grenoble.fr
  • Lyon, France
    • Recruiting
    • Centre hospitalier Lyon-Sud
    • Contact: Eddy COTTE; Phone Number: 33 4 78 86 23 71; Email: eddy.cotte@chu-lyon.fr
  • Marseille, France
    • Not yet recruiting
    • Institut Paoli Calmettes
    • Contact: Hélène MEILLAT; Phone Number: +33 4 91 22 36 60; Email: meillath@ipc.unicancer.fr
  • Marseille, France
    • Recruiting
    • CHU Timone - Assistance publique-Hôpitaux de Marseille
    • Contact: Diane MEGE; Phone Number: +33 4 91 38 57 99; Email: diane.mege@ap-hm.fr
  • Marseille, France
    • Recruiting
    • Hôpital Nord - Assistance publique- Hôpitaux de Marseille
    • Contact: Laura BEYER- BERJOT; Phone Number: +33 4 91 96 50 90; Email: laura.beyer@ap-hm.fr
  • Nantes, France
    • Recruiting
    • CHU Nantes
    • Contact: Emilie DUCHALAIS; Phone Number: +33 2 40 08 43 22; Email: emilie.duchalais@chu-nantes.fr
  • Paris, France
    • Recruiting
    • Hôpital de Bicêtre - Assistance Publique Hôpitaux de Paris
    • Contact: Solafah ABDALLA; Phone Number: +33 1 45 21 34 70; Email: solafah.abdalla@aphp.fr
  • Paris, France
    • Recruiting
    • Hôpital Saint Antoine - Assistance publique - Hôpitaux de Paris
    • Contact: Jérémie LEFEVRE; Phone Number: +33 1 71 97 04 19; Email: jeremie.lefevre@aphp.fr
  • Rennes, France
    • Recruiting
    • Chu Rennes
    • Contact: Véronique DESFOURNEAUX DENIS; Phone Number: +33 2 99 28 91 36; Email: veronique.desfournaux@chu-rennes.fr
  • Saint-Nazaire, France
    • Recruiting
    • Clinique Mutualiste de l'Estuaire
    • Contact: Maxime GERARD; Phone Number: +33 2 72 27 53 82; Email: maxime.gerard@hospigrandouest.fr
  • Toulouse, France
    • Recruiting
    • CHU Toulouse
    • Contact: Etienne BUSCAIL; Phone Number: 33 5 61 32 23 73; Email: ebuscail@me.com
  • Tours, France
    • Recruiting
    • CHRU Tours
    • Contact: Mehdi OUAISSI; Phone Number: +33 2 18 37 05 75; Email: m.ouaissi@chu-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria :

• 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization days	Cumulative duration of hospitalization days up to 90 days after the index surgery	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unplanned hospital readmission	Rate of unplanned hospital readmissions with emergency department visits at 90 days	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)	90 days
Unplanned consultations	Rate of unplanned consultations at 90 days	90 days
Postoperative morbidity	Number of patients presenting a complication out of the total number of patients	90 days
Severe postoperative morbidity	Severe postoperative morbidity at 90 days (Clavien-Dindo classification levels 3 and 4)	90 days
Visual Analog Scale at Day 3 for preoperative inclusions	Visual Analog Scale at Day 3 for preoperative inclusions. Visual Analog Scale is self-assessment scale (in cm) ranging from 0 (no pain) to 10 (maximum imaginable pain).	Day 3
Visual Analog Scale at Day 5 for preoperative inclusions	Visual Analog Scale at Day 5 for preoperative inclusions. Visual Analog Scale is self-assessment scale (in cm) ranging from 0 (no pain) to 10 (maximum imaginable pain).	Day 5
Rate of postoperative ileus at Day 3 for preoperative inclusions	Rate of postoperative ileus at Day 3 for preoperative inclusions	Day 3
Rate of postoperative ileus at Day 5 for preoperative inclusions	Rate of postoperative ileus at Day 5 for preoperative inclusions	Day 5
Return to Professional activities	Date of return to professional activities within 90 days	90 days
Quality of life questionnaires "Medical Outcomes Study 36-item Short-Form Health Survey"	Quality of life questionnaires"Medical Outcomes Study 36-item Short-Form Health Survey" (SF-36) at 30 days. It consists of 36 questions. Each question is assessed using a Likert scale with 3, 5, or 6 possible response levels. The 8 dimensions also allow for the calculation of two quality-of-life scores: the Physical Composite Score and the Mental Composite Score. The higher the score, the greater the capacity.	30 days
Quality of life questionnaires "Medical Outcomes Study 36-item Short-Form Health Survey"	Quality of life questionnaires "Medical Outcomes Study 36-item Short-Form Health Survey " (SF-36) at 90 days. It consists of 36 questions. Each question is assessed using a Likert scale with 3, 5, or 6 possible response levels. The 8 dimensions also allow for the calculation of two quality-of-life scores: the Physical Composite Score and the Mental Composite Score. The higher the score, the greater the capacity.	90 days
Quality of life questionnaires EQ-5D	Quality of life questionnaires EQ-5D at 30 days. The questionnaire 5-level EQ-5D version consists of 5 response items indicating an increasing severity of problems in the relevant dimension and a visual analog scale ranging from 0 to 100, assessing overall health status.	30 days
Quality of life questionnaires EQ-5D	Quality of life questionnaires EQ-5D at 90 days. The questionnaire 5-level EQ-5D version consists of 5 response items indicating an increasing severity of problems in the relevant dimension and a visual analog scale ranging from 0 to 100, assessing overall health status.	90 days
Total cost of the care pathway over 90 days	Costs will be estimated based on hospital stays (initial and any rehospitalizations), outpatient healthcare consumption (limited to medical consultations), and the remote monitoring platform	90 days
Patient satisfaction	Likert scale at 30 days to assess the level of patient satisfaction. This questionnaire consists of 3 items (statements) for which the respondent will express their degree of agreement or disagreement. Each statement will be associated with an integer number from 1 to 5 for the quantitative analysis of the data. The final score on this scale will therefore range between 3 and 15.	30 days
Number of days between surgery and the resumption of both gaseous and fecal transit within 90 days	Number of days between surgery and the resumption of both gaseous and fecal transit within 90 days	90 days
Number of patients maintained at home but discontinuing the use of the remote monitoring platform system before the end of follow-up	Number of patients maintained at home but discontinuing the use of the remote monitoring platform system before the end of follow-up	90 days
The reason for patients remaining at home after discontinuing the use of the remote monitoring platform system before the end of the follow-up	Number of patients maintained at home but discontinuing the use of the remote monitoring platform system before the end of follow-up, along with the reasons	90 days
Number of patients managed with the remote monitoring platform system	Number of patients managed with the remote monitoring platform system from the day the discharge criteria were met	90 days
Duration of use of remote monitoring plateform	Number of days between returning home with the remote monitoring platform system and the end of follow-up by the remote moinitoring platform	90 days
Characteristics of the care provided by the remote monitoring platform system	Characteristics of care provided through the remote monitoring platform system, according to the guidelines	90 days
Focus groups	Analysis of data collected through focus groups with professionals involved in the system	90 days
Patient and caregiver verbatims	Qualitative aspect : Analysis of patient and caregiver verbatims. Evaluation of the patient's and their caregiver's adherence to the system. The collection and analysis of the experiences of thirty families (one patient + one caregiver) will be conducted using two data collection tools : the diary and the semi-structured interview.	90 days
Patient verbatims on the post-operative experience	Qualitative aspect : Analysis of patient verbatims on the post-operative experience. Understanding of the patient's experience, including their feelings and anxiety during the postoperative period. The collection and analysis of the experiences of thirty families (one patient + one caregiver) will be conducted using two data collection tools : the diary and the semi-structured interview.	90 days
Healthcare professionals' verbatims	Qualitative aspect : Analysis of healthcare professionals' verbatims. Exploring the social, economic, and geographical inequalities in the use of outpatient and/or early hospital discharge. The experience of healthcare professionals will be collected during four focus groups and will help determine the conditions for the implementation and dissemination of the remote monitoring platform system beyond the partner centers and for other health situations.	90 days
Medical-economic endpoint	Medical-economic endpoint : Incremental cost-utility ratio (cost per QALY, Quality-Adjusted Life-Year).	90 days

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Ministry of Health, France; EPOCA U&I

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2025
• Primary Completion (Estimated): May 17, 2027
• Study Completion (Estimated): May 17, 2027

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): February 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: colorectal surgery; Rehospitalization; Hospital length of stay; remote monitoring platform
• Other Study ID Numbers: RC22_0452; 2024-A01770-47 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No