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Recruiting NCT06850688

Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery (CONTACT-GRECCAR 21)

No phase Interventional Colorectal Surgery Readmission

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remote monitoring platform.
Who it may be relevant to
Registry conditions: Colorectal Surgery, Readmission. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device 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 trai

Primary outcome measures

  • Hospitalization days [Time frame: 90 days]
Secondary outcome measures (12)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

France · 14 centers
  • CHU Angers — Angers
  • Clinique Tivoli- Ducos — Bordeaux
  • CHU Grenoble — Grenoble
  • Centre Hospitalier Lyon-Sud — Lyon
  • CHU Timone - Assistance publique-Hôpitaux de Marseille — Marseille
  • Hôpital Nord - Assistance publique- Hôpitaux de Marseille — Marseille
  • Institut Paoli Calmettes — Marseille
  • CHU Nantes — Nantes
  • … and 6 more centers

Identifiers

NCT: NCT06850688 · RC22_0452 · 2024-A01770-47

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗