An Evaluation of Multisense® to Ensure a Safe Return Home Following High-risk Gastrointestinal Surgery, Compared With Standard Care.

Rhythm Diagnostic Systems490 enrolled

Overview

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.

SENSE-ECO study is a prospective, multicenter, randomized open-label trial designed to evaluate the clinical and medico-economic impact of the MultiSense® remote monitoring solution for 490 high-risk patients (ASA 2 or 3) undergoing major digestive surgery. The primary objective is to demonstrate that using this Class IIa wearable patch to monitor vital signs-such as heart rate, $SpO\_2$, and respiratory rate-allows for a reduced initial hospital stay without increasing 30-day morbidity compared to standard care. In the experimental group, patients are equipped with the device 12 to 24 hours before discharge to continue continuous home monitoring for five days, while the study also assesses secondary factors including cost-effectiveness for the French healthcare system, patient quality of life via the fQoR-15 questionnaire, and organizational workload for medical staff. Conducted across five centers under the coordination of Dr. Ugo Marchese.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

490

Conditions

Reduction in the Initial Length of Stay

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria : * Adults (aged 18 and over) * Patients scheduled for gastrointestinal surgery : * 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 who have a personal mobile phone and Wi-Fi connectivity at home * Patients who provide written informed consent to participate in the study * Patients who are members of or beneficiaries of a social security scheme * Patients who are proficient in French Exclusion Criteria : * 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) * Patient already participating in a clinical trial

Locations (9)

CHU de Nice

Nice, Alpes-Maritimes, France

NOT_YET_RECRUITING

CHU Saint-étienne

Saint-Etienne, Auvergne-Rhône-Alpes, France

NOT_YET_RECRUITING

La Sagesse Mutualist Clinic

Rennes, Brittany Region, France

NOT_YET_RECRUITING

CHU de Besançon

Besançon, Doubs, France

NOT_YET_RECRUITING

CHU Reims

Reims, Grand Est, France

NOT_YET_RECRUITING

GHND

Bourgoin, Isère, France

NOT_YET_RECRUITING

CHU Charles-Nicolle

Rouen, Seine-Maritime, France

NOT_YET_RECRUITING

CHU Amiens-Picardie

Amiens, France

NOT_YET_RECRUITING

Hôpital Cochin, AP-HP Centre

Paris, France

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 30 days

The average length of the initial stay for both groups

Time frame: Up to 30 days

Secondary Outcomes

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

Time frame: 8days, 15days, 30days and 90days

Average number of deaths in each arm over 8 days, 15 days, 30 days and 90 days

Secondary "clinical" outcome measures

Time frame: 8 days, 15 days, 30 days and 90 days

Average total cumulative length of stay over 30 days

Secondary "clinical" outcome measures

Time frame: 30 days

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

Time frame: 30 days

Patient quality of life scores assessed at baseline, on discharge from hospital and at 30 days using the fQoR-15 questionnaire

Secondary "clinical" outcome measures Assess the impact on patient's quality of life fQoR-15 : French Quality of Recovery-15 15 : corresponds to the 15 multidimensional questions that make up the score. The total score ranges from 0 to 150 The higher the score, the better the quality of post-operative recovery High score = optimal recovery Low score = impaired recovery

Time frame: 30 days

Total 30-day healthcare costs (€) and cost-effectiveness comparing outcome differences between groups, including morbidity, length of stay, readmissions, patient severity, staff satisfaction, quality of life, and organisational impact.

Secondary "medico-economic" outcome measures

Time frame: 30 days

Net benefit to the healthcare system (€) from the roll-out of the Multisense solution in France (difference between incurred and avoided costs) over 4 years

Secondary "medico-economic" outcome measures

Time frame: 4 years

Average daily time (hours and minutes) spent on the platform by the remote monitoring team to monitor patients in the MultiSense group (collected via the MultiSense platform)