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Clinical Trial NCT06850688 (CONTACT) for Colorectal Surgery, Readmission is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery (CONTACT-GRECCAR 21)
Clinical Trial NCT06850688 (CONTACT) is an interventional study for Colorectal Surgery, Readmission that is recruiting. It started on 17 June 2025 with plans to enroll 362 participants. Led by Nantes University Hospital, it is expected to complete by 17 October 2026. The latest data from ClinicalTrials.gov was last updated on 3 December 2025.
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.
Official Title
Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery - A Multicenter Randomized Study
Conditions
Colorectal SurgeryReadmissionOther Study IDs
- CONTACT
- RC22_0452
- 2024-A01770-47 (Registry Identifier) (ID-RCB)
NCT ID Number
Start Date (Actual)
2025-06-17
Last Update Posted
2025-12-03
Completion Date (Estimated)
2026-10-17
Enrollment (Estimated)
362
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
colorectal surgery
remote monitoring platform
Hospital length of stay
Rehospitalization
remote monitoring platform
Hospital length of stay
Rehospitalization
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
No Interventionconventional 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. | N/A |
ExperimentalRemote 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. | 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 |
Primary Outcome Measures
Secondary 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 |
| 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 |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
Nantes University Hospital- EPOCA U&I
- Ministry of Health, France
Study Central Contact
Contact: Emilie DUCHALAIS, +33 2 40 08 43 22, [email protected]
14 Study Locations in 1 Countries
Clinique Tivoli- Ducos, Bordeaux, France
Quentin DENOST, Contact, 33 5 47 50 15 75, [email protected]
Recruiting
CHU Grenoble, Grenoble, France
Bertrand TRILLING, Contact, +33 4 76 76 93 77, [email protected]
Recruiting
Centre Hospitalier Lyon-Sud, Lyon, France
Eddy COTTE, Contact, 33 4 78 86 23 71, [email protected]
Recruiting
CHU Timone - Assistance publique-Hôpitaux de Marseille, Marseille, France
Diane MEGE, Contact, +33 4 91 38 57 99, [email protected]
Recruiting
Hôpital Nord - Assistance publique- Hôpitaux de Marseille, Marseille, France
Laura BEYER- BERJOT, Contact, +33 4 91 96 50 90, [email protected]
Recruiting
Institut Paoli Calmettes, Marseille, France
Hélène MEILLAT, Contact, +33 4 91 22 36 60, [email protected]
Not yet recruiting
CHU Nantes, Nantes, France
Emilie DUCHALAIS, Contact, +33 2 40 08 43 22, [email protected]
Recruiting
Hôpital de Bicêtre - Assistance Publique Hôpitaux de Paris, Paris, France
Solafah ABDALLA, Contact, +33 1 45 21 34 70, [email protected]
Recruiting
Hôpital Saint Antoine - Assistance publique - Hôpitaux de Paris, Paris, France
Jérémie LEFEVRE, Contact, +33 1 71 97 04 19, [email protected]
Recruiting
CHU Rennes, Rennes, France
Véronique DESFOURNEAUX DENIS, Contact, +33 2 99 28 91 36, [email protected]
Recruiting
Clinique Mutualiste de l'estuaire, Saint-Nazaire, France
Maxime GERARD, Contact, +33 2 72 27 53 82, [email protected]
Recruiting
CHU Toulouse, Toulouse, France
Etienne BUSCAIL, Contact, 33 5 61 32 23 73, [email protected]
Not yet recruiting