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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
6
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.
Chu Amiens
Amiens, France
CHU Angers
Angers, France
Clinique TIVOLI
Bordeaux, France
Chru Brest
Brest, France
CHU Grenoble Alpes
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)
Time frame: at Day 30
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
Time frame: at Day 1
Assess pain
Pain, by visual analog scale (0-10)
Time frame: at Day 0, Day 1, Day 2, Day 3, Day 4, Day 5 and Day 30
Assess opioid use
5-day opioid consumption rate
Time frame: at Day 5
Evaluate the complication rate
Presence of a complication according to the Clavien Dindo classification
Time frame: 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
Time frame: 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
Time frame: at Day 30
Assess the patient's quality of life and overall satisfaction
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Grenoble, France
Institut Paoli Calmettes
Marseille, France
Chu Nantes
Nantes, France
EuroQol 5D 3L standardized scale score (overall satisfaction) at pre-inclusion, Day 1, Day 5 and Day 30 post-surgery visit
Time frame: at Day 30
Evaluate the cost of care
Cost analysis (hospitalizations, consultations, re-interventions, time off work, transportation and SENSIUM system costs)
Time frame: To Day 1 at the end of study
Evaluate the evolution of vital parameters
Trend analysis of vital parameters
Time frame: To Day 1 at the end of study