At-home continuous monitoring after colorectal surgery to reduce readmissions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.