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

Not Applicable

Not yet recruiting

• Conditions: Colorectal Surgery; Readmission

• Registration Number: NCT06850688
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-27
• Last Update Posted: 2025-02-27
• Study Start: 2025-04-01
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 362

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hospitalization days	90 days	Cumulative duration of hospitalization days up to 90 days after the index surgery

Secondary Outcome Measures

Name	Time	Method
Unplanned hospital readmission	90 days	Rate of unplanned hospital readmissions with emergency department visits at 90 days
Difference between the initial hospital discharge date and the hospital readmission date	90 days	Difference between the initial hospital discharge date and the hospital readmission date (for readmitted patients)
Unplanned consultations	90 days	Rate of unplanned consultations at 90 days
Postoperative morbidity	90 days	Number of patients presenting a complication out of the total number of patients
Severe postoperative morbidity	90 days	Severe postoperative morbidity at 90 days (Clavien-Dindo classification levels 3 and 4)
Visual Analog Scale at Day 3 for preoperative inclusions	Day 3	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).
Visual Analog Scale at Day 5 for preoperative inclusions	Day 5	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).
Rate of postoperative ileus at Day 3 for preoperative inclusions	Day 3	Rate of postoperative ileus at Day 3 for preoperative inclusions
Rate of postoperative ileus at Day 5 for preoperative inclusions	Day 5	Rate of postoperative ileus at Day 5 for preoperative inclusions
Return to Professional activities	90 days	Date of return to professional activities within 90 days
Quality of life questionnaires "Medical Outcomes Study 36-item Short-Form Health Survey"	90 days	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.
Quality of life questionnaires EQ-5D	90 days	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.
Total cost of the care pathway over 90 days	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
Patient satisfaction	30 days	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.
Number of days between surgery and the resumption of both gaseous and fecal transit within 90 days	90 days	Number of days between surgery and the resumption of both gaseous and fecal transit within 90 days
Number of patients maintained at home but discontinuing the use of the remote monitoring platform system before the end of follow-up	90 days	Number of patients maintained at home but discontinuing the use of the remote monitoring platform system before the end of follow-up
The reason for patients remaining at home after discontinuing the use of the remote monitoring platform system before the end of the follow-up	90 days	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
Number of patients managed with the remote monitoring platform system	90 days	Number of patients managed with the remote monitoring platform system from the day the discharge criteria were met
Duration of use of remote monitoring plateform	90 days	Number of days between returning home with the remote monitoring platform system and the end of follow-up by the remote moinitoring platform
Characteristics of the care provided by the remote monitoring platform system	90 days	Characteristics of care provided through the remote monitoring platform system, according to the guidelines
Focus groups	90 days	Analysis of data collected through focus groups with professionals involved in the system
Patient and caregiver verbatims	90 days	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.
Patient verbatims on the post-operative experience	90 days	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.
Healthcare professionals' verbatims	90 days	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.
Medical-economic endpoint	90 days	Medical-economic endpoint : Incremental cost-utility ratio (cost per QALY, Quality-Adjusted Life-Year).

Trial Locations

Locations (14)

CHU Angers; 🇫🇷 Angers, France

Clinique Tivoli- Ducos; 🇫🇷 Bordeaux, France

CHU Grenoble; 🇫🇷 Grenoble, France

Centre Hospitalier Lyon-Sud; 🇫🇷 Lyon, France

CHU Timone - Assistance publique-Hôpitaux de Marseille; 🇫🇷 Marseille, France

Hôpital Nord - Assistance publique- Hôpitaux de Marseille; 🇫🇷 Marseille, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

CHU Nantes; 🇫🇷 Nantes, France

Hôpital de Bicêtre - Assistance Publique Hôpitaux de Paris; 🇫🇷 Paris, France

Hôpital Saint Antoine - Assistance publique - Hôpitaux de Paris; 🇫🇷 Paris, France

CHU Rennes; 🇫🇷 Rennes, France

Clinique Mutualiste de l'estuaire; 🇫🇷 Saint Nazaire, France

CHU Toulouse; 🇫🇷 Toulouse, France

CHRU Tours; 🇫🇷 Tours, France