At-home continuous monitoring after colorectal surgery to reduce readmissions
Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery - A Multicenter Randomized Study
This trial tests whether 30 days of at-home continuous remote monitoring after colorectal surgery helps people at higher risk of readmission compared with usual discharge care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 362 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 14 sites (Angers and 13 other locations) |
| Trial ID | NCT06850688 on ClinicalTrials.gov |
What this trial studies
Patients who had colorectal surgery and are at higher risk of returning to the hospital will be randomized to either 30 days of ambulatory continuous remote monitoring or to conventional discharge care. The remote monitoring platform collects physiologic and symptom data after discharge, with clinical follow-up triggered by detected concerns. Participants return for a postoperative visit at 30 days and receive a phone follow-up at 90 days to capture outcomes including rehospitalization and length of stay. The trial targets patients with anticipated early discharge or a predicted readmission risk above 10% using an adapted nomogram.
Who should consider this trial
Good fit: Adults (18+) who underwent colorectal resection or anastomosis within the past 28 days or are scheduled for such surgery and are at increased risk of readmission or expected to be discharged early are ideal candidates.
Not a fit: Patients at low risk for readmission, those without access to or comfort with remote monitoring technology, or those treated outside participating centers are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could reduce rehospitalizations and enable earlier detection and management of postoperative complications.
How similar studies have performed: Remote postoperative monitoring has shown promising results in other surgical groups, but evidence specific to colorectal surgery remains limited and not yet definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Angers and 13 other locations
- 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)
Study contacts
- Study coordinator: Emilie DUCHALAIS
- Email: emilie.duchalais@chu-nantes.fr
- Phone: +33 2 40 08 43 22
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.