The SENSE-ECO study is a prospective, randomized trial of 490 high-risk patients designed to show that the MultiSense® remote monitoring patch safely reduces hospital stays following major digestive surgery. By continuously tracking vital signs for five days at home, the device aims to maintain clinical safety and quality of life while decreasing overall healthcare costs for the French medical system.
Adults (aged 18 and over)
Major gastrointestinal cancer surgery (pancreas, liver, stomach, oesophagus, rectum)
Colorectal surgery (rectal resection, surgery on the rectum and anus other than rectal resection, minor or major surgery on the small intestine and colon)
Patients in non-critical care with a high risk of post-surgical complications (ASA score 2 or 3)
Patients with a contraindication to the use of the device as described in the instructions for use (in particular: known skin allergy to adhesives or silicone, active implantable medical device such as a pacemaker or defibrillator, need for an MRI scan during the intended use of the device, intended application site of the device being tattooed, infected, ulcerated or damaged)
Any other condition which, in the investigator's opinion, would compromise the patient's safety or prevent compliance with the requirements of the protocol
Pregnant or breastfeeding patient
Adult under legal protection (under guardianship, curatorship or judicial protection)
Parallel
Monitoring by MultiSense®
DeviceThe MultiSense device will be placed on the patient's back and will allow physicians to remotely monitor six biological parameters
Mean CCI score of the Detailed Complications Index, calculated on the basis of complications recorded according to the Clavien-Dindo classification over a 30 day postoperative period for each of the two groups: the MultiSense group and Standard group
The Clavien-Dindo classification is a system used in surgery to classify postoperative complications according to their severity
The average length of the initial stay for both groups
Average CCI score from the Detailed Complications Index, calculated based on complications recorded according to the Clavien-Dindo classification over 8days, 15days, 30days and 90days post-surgery for each of the two groups: MultiSense® grp & Standad grp
Secondary "clinical" outcome measures
Average number of deaths in each arm over 8 days, 15 days, 30 days and 90 days
Secondary "clinical" outcome measures
Average total cumulative length of stay over 30 days
Secondary "clinical" outcome measures
Average number of hospital readmissions among patients receiving MultiSense® compared with patients receiving standard care, over a 30 days period; severity of the patient at readmission assessed using the Clavien-Dindo classification
Secondary "clinical" outcome measures
Click on the lead sponsor to view all of their trials.