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Recruiting NCT07514286

Assessment of the Feasibility and Organisational Impact of a Care Pathway Incorporating the MultiSense® Medical Device for Post-operative Home Monitoring of Elderly Patients.

No phase Interventional Average Length of Stay Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Monitoring by MultiSense.
Who it may be relevant to
Registry conditions: Average Length of Stay, Surgery. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

Assessing the clinical and organisational impact of a home-based post-operative monitoring strategy incorporating the MultiSense® device involving 80 patients aged 65 years and over who have undergone major surgery.

Detailed description

Evaluate the clinical and organisational impact of a post-operative home monitoring strategy incorporating the MultiSense® device in elderly patients.

The study will be conducted in a multicentre setting, involving 80 patients aged 65 years and over who have undergone major surgery.

Interventions

  • Device Monitoring by MultiSense
    The MultiSense device will be placed on the patient's back and will allow physicians to remotely monitor six biological parameters

Primary outcome measures

  • The percentage of patients whose care was deemed satisfactory [Time frame: 7 days]
Secondary outcome measures (12)
  • Average length of initial hospital stay following surgery [Time frame: 7 days]
  • Percentage of patients requiring unscheduled care related to surgery at 30 days [Time frame: 30 days]
  • Percentage of patients with at least one unplanned rehospitalization following telemonitoring and at 30 days [Time frame: 30 days]
  • Percentage of patients with at least one visit to the emergency department following telemonitoring and at day 30 [Time frame: 30 days]
  • Percentage of patients with at least one grade 3 to 5 complication according to the Clavien-Dindo classification at 30 days [Time frame: 30 days]
  • Number of unplanned rehospitalizations and/or emergency department visits at 30 days (total and per patient) [Time frame: 30 days]
  • Number of unscheduled visits (to a general practitioner or a surgeon) at 30 days (total and per patient) [Time frame: 30 days]
  • Quality of postoperative recovery using the French version of the fQoR-15 scale at hospital discharge (V2) and at 30 days (V4) [Time frame: 30 days]
  • Measurement of the overall index score for the EQ-5D-5L questionnaire at preoperative assessment (V0), at hospital discharge (V2), and at 30 days (V4) [Time frame: 30 days]
  • Total length of hospital stay (initial admission and readmission) at 30 days [Time frame: 30 days]
  • DAOH30 (Days Alive and Out of Hospital) or Days of Independence at Home at Day 30, defined as the number of days during which the patient recovered independently at home without requiring hospitalization or rehospitalization, during the 30-day postoper [Time frame: 30 days]
  • Percentage of patients who did not comply with remote monitoring via MultiSense® (non-compliance is defined as the patient discontinuing monitoring before reaching 80% of the scheduled duration, which corresponds to the 4th day) [Time frame: 4th day]

Eligibility criteria

Inclusion criteria

  • Patient aged 65 or over
  • Patient eligible for remote monitoring using the MultiSense® device
  • No psychiatric illness that would prevent them from giving informed consent or receiving optimal treatment and follow-up care
  • Subject affiliated with a health insurance scheme
  • Subject able to read and understand English
  • Subject who has signed an informed consent form
  • Subjects indicated for scheduled surgery
  • Patients indicated for scheduled surgery :
  • Transverse colectomy, by laparotomy
  • Hepatic laparoscopy
  • Laparoscopic or laparoscopic liver surgery (code hlfc or hlfa for procedures)
  • Hysterectomy
  • Adnexectomy
  • Parietal surgery (eventration)
  • Rectal resection
  • Right and left colectomy
  • Stoma closure by direct approach

Exclusion criteria

  • Patients already participating in an interventional clinical trial.
  • Patients subject to legal protection measures, guardianship, curatorship, or deprived of their liberty by judicial or administrative decision.
  • Patients hospitalised without consent.
  • Patients unable to complete a questionnaire and without a close relative to assist them in using the solution.
  • Patients admitted to or residing in a health or social care facility (other than for the surgery itself).
  • Persons admitted to or residing in a health or social care institution (other than for the surgery itself);
  • Persons unable to give their free and informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 4 centers
  • Western Cancer Institute of Angers — Angers
  • Bergonié Insititute — Bordeaux
  • Inter-municipal Hospital Centre of Mont-de-marsan — Mont-de-Marsan
  • Western Cancer Institute of Nantes — Nantes

Identifiers

NCT: NCT07514286 · 2025 - 02 · N° IDRCB: 2025-A02326-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗