MedTrace Logo

Evaluation of a Telemedicine System for Patients Carried for Bariatric Surgery

NCT03834181 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-02-10

No results posted yet for this study

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.

Conditions

  • Bariatric Surgery Candidate

Interventions

DEVICE

Monitoring evaluation by connected devices: Wristband activity tracker "Garmin Vivosmart® 3", "Fora® Scale 550", "Terraillon® Tensioscreen", Pulse oximeter "Nonin® 3230", thermometer "Fora® IR20b"

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

Sponsors & Collaborators

  • IHU Strasbourg

    lead OTHER

Principal Investigators

  • Michel Vix, MD · Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03834181 on ClinicalTrials.gov