Evaluation of a Telemedicine System for Patients Carried for Bariatric Surgery
Condition: Bariatric Surgery Candidate
Study type: Interventional

Summary: 
      This study is intended to study the feasibility of a telemedicine system to monitor and
      control certain vital parameters before and after surgery for obesity. During the
      preoperative preparation phase, weight, exercise, blood pressure and heart rate are recorded
      and transmitted to the patient's surgeon. In the immediate post operative period, the heart
      rate is a sensitive and reliable indicator of the occurrence of a complication. A telemetry
      system will allow rapid home return, continuous monitoring and early warning in the event of
      a problem. Prolonged follow-up identical to that started preoperatively should allow
      improvement and better control of weight loss by monitoring especially physical exercise.
    

Detailed description: 
      The evolution of the health system requires a rationalization of the supply of care and the
      care of patients. It has allowed the evolution and generalization of ambulatory surgery for
      certain pathologies. For other pathologies, a hospital stay is still desirable with a
      tendency to decrease the length of stay. Thanks to the telemedicine platforms, specialized
      medical monitoring can be extended pre- and post-operatively to ensure good patient
      preparation and quality secure follow-up.

      Early return to home is an essential parameter in optimizing the distribution of hospital
      resources. Several studies have shown improved clinical outcomes, fewer complications, more
      beds available, and lower hospital costs. The development of outpatient surgery has enabled
      the establishment of systems allowing a return home in secure conditions. Early return home
      is also a wish of the patient. He becomes an actor of his own health. Obesity surgery is an
      exemplary specialty for the care of patients. The ideal course of care is perfectly codified
      both preoperatively and postoperatively. Nevertheless, this ideal care path is not always
      respected especially in structures too small to offer a real integrated multidisciplinary
      follow-up. Pre- and postoperative management solutions on the Internet exist but require a
      voluntary and active adherence of the patient. They allow a stronger involvement of the
      patient in his approach, they are nascent and integrate no connected solution for automated
      monitoring of the patient. Telemedicine can now allow continuous monitoring without the need
      for face-to-face interaction. The automatic collection of the physical activity and the heart
      rate makes it possible to guarantee the involvement of the patient in his preparation. After
      the intervention, the monitoring of the occurrence of complications can be delegated to
      connected objects with alert transmission according to parameters defined in advance. In
      particular, the heart rate is a sensitive indicator and will be followed by two sensors
      (activity bracelet and pulse oximeter). These complications occur mainly in the 15 days
      following the intervention, they are rare in immediate postoperative. The hospital stay is no
      longer necessary for a simple surveillance. In case of receipt of an alert, the surgeon
      contacts the patient to check his state of health. An adapted action is then engaged.

      The late postoperative follow-up throughout this document corresponds to the phase following
      the immediate postoperative phase. This late postoperative follow-up can be improved with the
      support of telemonitoring (activity, change in weight.) The addition of connected devices
      allows a stronger and faster interaction between the patient and his doctors, providing close
      monitoring and appropriate support.

      The study focuses on assessing the reliability of a remote monitoring system. The
      implementation of this remote monitoring system is subordinated to the reliability of the
      data transmissions between the connected objects and the remote site which receives the data,
      interprets them and generates the alerts.

      The motivation of the patient is appreciated by the acceptance of connected objects.

      During this study, the remote monitoring system is offered in addition to the usual care. The
      usual care does not change and is not impaired. This study concerns only one group of
      patients, there is no control group since the investigators seek to validate the reliability
      of remote surveillance.
    

Intervention name(s): Monitoring evaluation by connected devices: Wristband activity tracker "Garmin Vivosmart® 3", "Fora® Scale 550", "Terraillon® Tensioscreen", Pulse oximeter "Nonin® 3230", thermometer "Fora® IR20b"
Intervention type(s): Device
Intervention description(s): All patients will be monitored before and after the bariatric surgery:
During the preoperative preparation phase: weight, exercise, blood pressure and heart rate
In the immediate post operative period: continuous monitoring of the heart rate with a telemetry system
Prolonged follow-up: weight, exercise, blood pressure and heart rate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Connected devices; Telemetry; Obesity surgery