Feasibility Study of Early Return-home After Colorectal Surgery Using a SENSIUM® Vital Parameter Monitoring Device
NCT ID: NCT05610995
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
6 participants
INTERVENTIONAL
2023-07-22
2024-10-08
Brief Summary
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The device SENSIUM is a tool to monitor vital signs (respiratory rate, heart rate and temperature) by applying a connected skin patch in order to detect complications early.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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SENSIUM Group
Patients in the experimental group will be discharged with the device after an assessment on Day 1.
SENSIUM Patch
The SENSIUM device is a tool to monitor vital signs by applying a connected skin patch whose objective is to detect complications early. The health data is transmitted to the practitioner and in case of disturbance of the parameters, an alert is sent. The patient can be called for consultation or hospitalization if necessary. This device has been tested under real clinical conditions in surgical units. The continuous monitoring of vital signs resulted in earlier detection of sepsis, earlier administration of antibiotics, shorter average length of stay and lower 30-day readmission rates.
ERAS standard Group
Patients in the control group will receive the usual ERAS (conventional hospitalization for clinicobiological monitoring).
No interventions assigned to this group
Interventions
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SENSIUM Patch
The SENSIUM device is a tool to monitor vital signs by applying a connected skin patch whose objective is to detect complications early. The health data is transmitted to the practitioner and in case of disturbance of the parameters, an alert is sent. The patient can be called for consultation or hospitalization if necessary. This device has been tested under real clinical conditions in surgical units. The continuous monitoring of vital signs resulted in earlier detection of sepsis, earlier administration of antibiotics, shorter average length of stay and lower 30-day readmission rates.
Eligibility Criteria
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Inclusion Criteria
2. ASA score 1-3
3. Colonic or rectal resection with anastomosis
4. Minimally invasive surgery
5. Patient living close to the hospital (\<1 hour drive)
6. Patient accompanied for 48 hours
7. Body Mass Index \< 40
8. Patient information and signature of consent
9. Patient affiliated to a social insurance plan
10. A pregnancy test must be performed before inclusion in women of childbearing age.
1. Socially isolated patient and/or no 3G cell signal
2. Severe comorbidities defined as any of these characteristics:
1. Severe malnutrition (albumin \<30g/l)
2. Severe anemia \< 80 g/dl
3. Insulin-dependent diabetes type 1
e. Patient under anticoagulation f. Severe renal insufficiency
3. History of psychiatric illness with medication requirements
4. Persons referred to in articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of liberty by judicial or administrative decision, persons under legal protection)
5. Patient not wishing to enter the study
6. Patient in a period of exclusion from another study or ongoing participation in an interventional study
Exclusion Criteria
2. Per operative conversion to laparotomy
3. CHUNG score \> 8
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Locations
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Chu Amiens
Amiens, , France
CHU Angers
Angers, , France
Clinique TIVOLI
Bordeaux, , France
Chru Brest
Brest, , France
CHU Grenoble Alpes
Grenoble, , France
Institut Paoli Calmettes
Marseille, , France
Chu Nantes
Nantes, , France
Countries
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Other Identifiers
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38RC21.0379
Identifier Type: -
Identifier Source: org_study_id