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recruitment faisibility
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SENSIUM Group | Experimental | Patients in the experimental group will be discharged with the device after an assessment on Day 1. |
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| ERAS standard Group | No Intervention | Patients in the control group will receive the usual ERAS (conventional hospitalization for clinicobiological monitoring). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SENSIUM Patch | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Non-inclusion Criteria:
Socially isolated patient and/or no 3G cell signal
Severe comorbidities defined as any of these characteristics:
e. 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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Amiens | Amiens | France | ||||
| CHU Angers |
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Prospective, multicenter, randomized, two-arm, parallel, open-label, interventional controlled trial with masked outcome assessment (PROBE design)
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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 |
| Angers |
| France |
| Clinique TIVOLI | Bordeaux | France |
| Chru Brest | Brest | France |
| CHU Grenoble Alpes | Grenoble | France |
| Institut Paoli Calmettes | Marseille | France |
| Chu Nantes | Nantes | France |