Premature Exit After Colorectal SurgeryColo-SENSIUMNCT05610995
Feasibility Study of Early Return-home After Colorectal Surgery Using a SENSIUM® Vital Parameter Monitoring Device
A study testing SENSIUM Patch in people with Premature Exit After Colorectal Surgery, run by University Hospital, Grenoble at 7 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Premature Exit After Colorectal Surgery
- What is being tested?
- SENSIUM Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 7 sitesFrance
- Study dates
- 22 Jul 2023to 8 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- ASA score 1-3
- Colonic or rectal resection with anastomosis
- Minimally invasive surgery
- Patient living close to the hospital (<1 hour drive)
- Patient accompanied for 48 hours
Show all 21Show fewer
- Body Mass Index < 40
- Patient information and signature of consent
- Patient affiliated to a social insurance plan
- A pregnancy test must be performed before inclusion in women of childbearing age.
- Non-inclusion Criteria:
- Socially isolated patient and/or no 3G cell signal
- Severe comorbidities defined as any of these characteristics:
- Severe malnutrition (albumin <30g/l)
- Severe anemia < 80 g/dl
- Insulin-dependent diabetes type 1
- Patient under anticoagulation f. Severe renal insufficiency
- History of psychiatric illness with medication requirements
- 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)
- Patient not wishing to enter the study
- Patient in a period of exclusion from another study or ongoing participation in an interventional study
Who cannot join
- Stoma preparation
- Per operative conversion to laparotomy
- CHUNG score > 8
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Chu Amiens
Amiens
CHU Angers
Angers
Clinique TIVOLI
Bordeaux
Chru Brest
Brest
CHU Grenoble Alpes
Grenoble
Institut Paoli Calmettes
Marseille
Chu Nantes
Nantes
About this study
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.
- Conditions
- Premature Exit After Colorectal Surgery
- Being tested
- SENSIUM Patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSIUM PatchDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SENSIUM Group | Experimental | Patients in the experimental group will be discharged with the device after an assessment on Day 1. Receives: Device: SENSIUM Patch |
| ERAS standard Group | No intervention | Patients in the control group will receive the usual ERAS (conventional hospitalization for clinicobiological monitoring). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at Day 30
Secondary outcomes (9)
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
Measured: at Day 1
Assess pain
Pain, by visual analog scale (0-10)
Measured: at Day 0, Day 1, Day 2, Day 3, Day 4, Day 5 and Day 30
Assess opioid use
5-day opioid consumption rate
Measured: at Day 5
Evaluate the complication rate
Presence of a complication according to the Clavien Dindo classification
Measured: 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
Measured: 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
Measured: 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
Measured: at Day 30
Evaluate the cost of care
Cost analysis (hospitalizations, consultations, re-interventions, time off work, transportation and SENSIUM system costs)
Measured: To Day 1 at the end of study
Evaluate the evolution of vital parameters
Trend analysis of vital parameters
Measured: To Day 1 at the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start22 Jul 2023
- Primary completion8 Oct 2024
- Study completion8 Oct 2024
Why it stopped: recruitment faisibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Exit After Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, randomized, two-arm, parallel, open-label, interventional controlled trial with masked outcome assessment (PROBE design)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610995
- Sponsor's protocol ID
- 38RC21.0379
- Acronym
- Colo-SENSIUM
- Status last verified
- Dec 2025
- First submitted
- 20 Sep 2022
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Early Return-home After Colorectal Surgery Using a SENSIUM® Vital Parameter Monitoring Device
- ClinicalTrials.gov ID
- NCT05610995
- Acronym / sponsor ID
- Colo-SENSIUM / 38RC21.0379
- Conditions
- Premature Exit After Colorectal Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment faisibility
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 22 Jul 2023 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, multicenter, randomized, two-arm, parallel, open-label, interventional controlled trial with masked outcome assessment (PROBE design)
| Arm | Type | Receives |
|---|---|---|
| SENSIUM Group | Experimental | Device: SENSIUM PatchPatients in the experimental group will be discharged with the device after an assessment on Day 1. |
| ERAS standard Group | No intervention | –Patients in the control group will receive the usual ERAS (conventional hospitalization for clinicobiological monitoring). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age ≥ 18 years
- ASA score 1-3
- Colonic or rectal resection with anastomosis
- Minimally invasive surgery
- Patient living close to the hospital (<1 hour drive)
Key exclusion criteria (3 listed)
- Stoma preparation
- Per operative conversion to laparotomy
- CHUNG score > 8
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SENSIUM PatchThe 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. | Device | SENSIUM Group |
Primary outcome
Evaluating the impact on length of stay of a return-to-home monitoring device versus enhanced rehabilitation after bowel resection surgery with anastomosis
Time frame: at Day 30
Overall length of stay of the patient (index stay, and possible re-hospitalizations)
9 secondary outcomes
Assess transit recovery
Time frame: at Day 1
Assess pain
Time frame: at Day 0, Day 1, Day 2, Day 3, Day 4, Day 5 and Day 30
Assess opioid use
Time frame: at Day 5
Evaluate the complication rate
Time frame: at Day 30 according to the postoperative management performed
Evaluate the rate of re-hospitalization performed
Time frame: To the post-surgical hospital discharge at Day 30
Assess the rate of unscheduled visits
Time frame: at Day 30
Assess the patient's quality of life and overall satisfaction
Time frame: at Day 30
Evaluate the cost of care
Time frame: To Day 1 at the end of study
Evaluate the evolution of vital parameters
Time frame: To Day 1 at the end of study
Results and safety
The study was stopped early (reason given: recruitment faisibility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SENSIUM Patch in people with Premature Exit After Colorectal Surgery, run by University Hospital, Grenoble at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment faisibility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the impact on length of stay of a return-to-home monitoring device versus enhanced rehabilitation after bowel resection surgery with anastomosis (time frame: at Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.