Feasibility Study of Early Return-home After Colorectal Surgery Using a SENSIUM® Vital Parameter Monitoring Device (Colo-SENSIUM)

The principal aim of this study is to evaluate the impact on length of stay of a return-to-home monitoring device versus enhanced rehabilitation after bowel resection surgery with anastomosis.

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.

Study Overview

• Status: Terminated
• Conditions: Premature Exit After Colorectal Surgery
• Intervention / Treatment: Device: SENSIUM Patch

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU Amiens
  • Angers, France
    • CHU Angers
  • Bordeaux, France
    • Clinique Tivoli
  • Brest, France
    • CHRU Brest
  • Grenoble, France
    • Chu Grenoble Alpes
  • Marseille, France
    • Institut Paoli Calmettes
  • Nantes, France
    • Chu Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years
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.

Non-inclusion Criteria:

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:

1. Stoma preparation
2. Per operative conversion to laparotomy
3. CHUNG score > 8

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SENSIUM Group; Patients in the experimental group will be discharged with the device after an assessment on Day 1.	Device: 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.
No Intervention: ERAS standard Group; Patients in the control group will receive the usual ERAS (conventional hospitalization for clinicobiological monitoring).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluating the impact on length of stay of a return-to-home monitoring device versus enhanced rehabilitation after bowel resection surgery with anastomosis	Overall length of stay of the patient (index stay, and possible re-hospitalizations)	at Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess transit recovery	Time of resumption of transit formalized by the resumption of gas, the time being calculated between the closure of the skin and the first gas in hours	at Day 1
Assess pain	Pain, by visual analog scale (0-10)	at Day 0, Day 1, Day 2, Day 3, Day 4, Day 5 and Day 30
Assess opioid use	5-day opioid consumption rate	at Day 5
Evaluate the complication rate	Presence of a complication according to the Clavien Dindo classification	at Day 30 according to the postoperative management performed
Evaluate the rate of re-hospitalization performed	Presence of a rehospitalization between the post-surgical hospital discharge and Day 30	To the post-surgical hospital discharge at Day 30
Assess the rate of unscheduled visits	Presence of an unscheduled consultation at Day 30 post-surgery	at Day 30
Assess the patient's quality of life and overall satisfaction	EuroQol 5D 3L standardized scale score (overall satisfaction) at pre-inclusion, Day 1, Day 5 and Day 30 post-surgery visit	at Day 30
Evaluate the cost of care	Cost analysis (hospitalizations, consultations, re-interventions, time off work, transportation and SENSIUM system costs)	To Day 1 at the end of study
Evaluate the evolution of vital parameters	Trend analysis of vital parameters	To Day 1 at the end of study

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2023
• Primary Completion (Actual): October 8, 2024
• Study Completion (Actual): October 8, 2024

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 38RC21.0379

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No