Colorectal SurgeryCONTACTNCT06850688
Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery (CONTACT-GRECCAR 21)
A study testing Remote monitoring platform in people with Colorectal Surgery and Readmission, run by Nantes University Hospital at 14 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery, Readmission
- What is being tested?
- Remote monitoring platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 14 sitesFrance
- Study dates
- 17 Jun 2025to 17 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
France14 sites, 14 recruiting
- Recruiting
CHU Angers
Angers
Aurélien VENARA, +33 2 41 35 36 18, AuVenara@chu-angers.fr
- Recruiting
Clinique Tivoli- Ducos
Bordeaux
Quentin DENOST, 33 5 47 50 15 75, q.denost@bordeaux-colorectal-institute.fr
- Recruiting
CHU Grenoble
Grenoble
Bertrand TRILLING, +33 4 76 76 93 77, btrilling@chu-grenoble.fr
- Recruiting
Centre Hospitalier Lyon-Sud
Lyon
Eddy COTTE, 33 4 78 86 23 71, eddy.cotte@chu-lyon.fr
- Recruiting
CHU Timone - Assistance publique-Hôpitaux de Marseille
Marseille
Diane MEGE, +33 4 91 38 57 99, diane.mege@ap-hm.fr
- Recruiting
Hôpital Nord - Assistance publique- Hôpitaux de Marseille
Marseille
Laura BEYER- BERJOT, +33 4 91 96 50 90, laura.beyer@ap-hm.fr
- Not yet recruiting
Institut Paoli Calmettes
Marseille
Hélène MEILLAT, +33 4 91 22 36 60, meillath@ipc.unicancer.fr
- Recruiting
CHU Nantes
Nantes
Emilie DUCHALAIS, +33 2 40 08 43 22, emilie.duchalais@chu-nantes.fr
- Recruiting
Hôpital de Bicêtre - Assistance Publique Hôpitaux de Paris
Paris
Solafah ABDALLA, +33 1 45 21 34 70, solafah.abdalla@aphp.fr
- Recruiting
Hôpital Saint Antoine - Assistance publique - Hôpitaux de Paris
Paris
Jérémie LEFEVRE, +33 1 71 97 04 19, jeremie.lefevre@aphp.fr
- Recruiting
CHU Rennes
Rennes
Véronique DESFOURNEAUX DENIS, +33 2 99 28 91 36, veronique.desfournaux@chu-rennes.fr
- Recruiting
Clinique Mutualiste de l'estuaire
Saint-Nazaire
Maxime GERARD, +33 2 72 27 53 82, maxime.gerard@hospigrandouest.fr
- Recruiting
CHU Toulouse
Toulouse
Etienne BUSCAIL, 33 5 61 32 23 73, ebuscail@me.com
- Recruiting
CHRU Tours
Tours
Mehdi OUAISSI, +33 2 18 37 05 75, m.ouaissi@chu-tours.fr
About this study
Official title: 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.
- Conditions
- Colorectal Surgery, Readmission
- Being tested
- Remote monitoring platform
- Keywords
- colorectal surgery, remote monitoring platform, Hospital length of stay, Rehospitalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote monitoring platformDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Remote monitoring platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization days
Cumulative duration of hospitalization days up to 90 days after the index surgery
Measured: 90 days
Secondary outcomes (27)
Unplanned hospital readmission
Rate of unplanned hospital readmissions with emergency department visits at 90 days
Measured: 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)
Measured: 90 days
Unplanned consultations
Rate of unplanned consultations at 90 days
Measured: 90 days
Severe postoperative morbidity
Severe postoperative morbidity at 90 days (Clavien-Dindo classification levels 3 and 4)
Measured: 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).
Measured: 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).
Measured: Day 5
Rate of postoperative ileus at Day 3 for preoperative inclusions
Rate of postoperative ileus at Day 3 for preoperative inclusions
Measured: Day 3
Rate of postoperative ileus at Day 5 for preoperative inclusions
Rate of postoperative ileus at Day 5 for preoperative inclusions
Measured: Day 5
Postoperative morbidity
Number of patients presenting a complication out of the total number of patients
Measured: 90 days
Return to Professional activities
Date of return to professional activities within 90 days
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 90 days
Focus groups
Analysis of data collected through focus groups with professionals involved in the system
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 90 days
Medical-economic endpoint
Medical-economic endpoint : Incremental cost-utility ratio (cost per QALY, Quality-Adjusted Life-Year).
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start17 Jun 2025
- Primary completion17 May 2027 (estimated)
- Study completion17 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- EPOCA U&I, Ministry of Health, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850688
- Sponsor's protocol ID
- RC22_0452
- Other IDs
- 2024-A01770-47
- Acronym
- CONTACT
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery - A Multicenter Randomized Study
- ClinicalTrials.gov ID
- NCT06850688
- Acronym / sponsor ID
- CONTACT / RC22_0452
- Conditions
- Colorectal Surgery, Readmission
- Keywords
- colorectal surgery, remote monitoring platform, Hospital length of stay, Rehospitalization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- EPOCA U&I, Ministry of Health, France
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 17 May 2027 (estimated)
- Study completion
- 17 May 2027 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Remote monitoring platformPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote monitoring platformEPOCA 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 | Device | Remote monitoring plateform |
Primary outcome
Hospitalization days
Time frame: 90 days
Cumulative duration of hospitalization days up to 90 days after the index surgery
27 secondary outcomes
Unplanned hospital readmission
Time frame: 90 days
Difference between the initial hospital discharge date and the hospital readmission date
Time frame: 90 days
Unplanned consultations
Time frame: 90 days
Severe postoperative morbidity
Time frame: 90 days
Visual Analog Scale at Day 3 for preoperative inclusions
Time frame: Day 3
Visual Analog Scale at Day 5 for preoperative inclusions
Time frame: Day 5
Rate of postoperative ileus at Day 3 for preoperative inclusions
Time frame: Day 3
Rate of postoperative ileus at Day 5 for preoperative inclusions
Time frame: Day 5
Postoperative morbidity
Time frame: 90 days
Return to Professional activities
Time frame: 90 days
Quality of life questionnaires "Medical Outcomes Study 36-item Short-Form Health Survey"
Time frame: 30 days
Quality of life questionnaires "Medical Outcomes Study 36-item Short-Form Health Survey"
Time frame: 90 days
Quality of life questionnaires EQ-5D
Time frame: 30 days
Quality of life questionnaires EQ-5D
Time frame: 90 days
Total cost of the care pathway over 90 days
Time frame: 90 days
Patient satisfaction
Time frame: 30 days
Number of days between surgery and the resumption of both gaseous and fecal transit within 90 days
Time frame: 90 days
Number of patients maintained at home but discontinuing the use of the remote monitoring platform system before the end of follow-up
Time frame: 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
Time frame: 90 days
Number of patients managed with the remote monitoring platform system
Time frame: 90 days
Duration of use of remote monitoring plateform
Time frame: 90 days
Characteristics of the care provided by the remote monitoring platform system
Time frame: 90 days
Focus groups
Time frame: 90 days
Patient and caregiver verbatims
Time frame: 90 days
Patient verbatims on the post-operative experience
Time frame: 90 days
Healthcare professionals' verbatims
Time frame: 90 days
Medical-economic endpoint
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote monitoring platform in people with Colorectal Surgery and Readmission, run by Nantes University Hospital at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilie DUCHALAIS (+33 2 40 08 43 22, emilie.duchalais@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization days (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.