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ClinicalTrials.gov ID

NCT06850688

Lead Sponsor

Nantes University HospitalOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

362Estimated

Last Update Posted

Mar 19, 2026Actual

Start Date

Jun 17, 2025Actual

Primary Completion Date

May 17, 2027Estimated

Completion Date

May 17, 2027Estimated

Official Title

Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery - A Multicenter Randomized Study

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.

• Colorectal Surgery
• Readmission

• Remote monitoring platform

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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.

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Nantes University HospitalOTHER

Collaborators

EPOCA U&IINDUSTRY

Ministry of Health, FranceOTHER_GOV

btrilling@chu-grenoble.fr+33 4 76 76 93 77

emilie.duchalais@chu-nantes.fr+33 2 40 08 43 22

veronique.desfournaux@chu-rennes.fr+33 2 99 28 91 36

ebuscail@me.com33 5 61 32 23 73

m.ouaissi@chu-tours.fr+33 2 18 37 05 75