Place of Connected Tools in Bariatric Patients Follow-up.

May 17, 2023 updated by: Elsan

Place of Connected Tools in the Follow-up of the Bariatric Patient: Can They Allow Rapid Management of Complications and Reduce Lost of Follow-up During Postoperative Period?

The aim of this study is to assess the safety (in terms of post-operative complications) of the use of connected devices for the monitoring of patients operated on by longitudinal laparoscopic gastrectomy (LSG) and discharged 24 hours after surgery according to the protocol Enhanced Recovery After Surgery (ERAS).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Connected devices, such as electronic scales and brachial cuffs used during the preoperative period, can help patients to self-control their weight and blood pressure and to better control certain risk factors for surgery. In addition, in order to reduce the number of deaths in the wards after surgery, connected devices have been designed to continuously monitor the vital parameters of patients. Subbe et al. recently showed that the use of wireless sensors to continuously monitor heart rate, respiratory rate, blood pressure and Oxygen Saturation by Pulse Oximetry (SpO2) reduced the number of cardiac arrests and mortality during hospitalization. Likewise, connected devices could potentially be used to monitor the patient directly at home and thus allow a faster discharge from the hospital without increasing the risks for the patient. At the current stage, there are no studies that have demonstrated the benefit of using the tools connected in postoperative follow-up in bariatric surgery.

Recently, thanks to the growth of experience and the application of the ERAS method, the postoperative stay at LSG has significantly decreased. Despite this, there are still very few centers that perform this operation in outpatient surgery or with a 24-hour hospital stay. This is probably due not only to a strict selection criteria, but also to the surgeon's concern to discharge the patient too early without medical supervision. In this context, the use of connected devices making it possible to monitor the patient directly at home and therefore theoretically continue a kind of medical surveillance could make it possible to increase the number of LSG performed in outpatient surgery. In addition, another advantage of this postoperative monitoring system is that it gives the patient a central role in the healing process after surgery. Thanks to devices and the Internet platform, the patient actively participates in his monitoring and remains in permanent contact with the surgical department. In this way, the feeling of fragility and loneliness that often feels the patient when he quickly returns home is reduced. Thus, compared to a small expense related to the purchase of devices, this would result in a significant reduction in hospital costs for the health system. The more important limitation of this procedure remains the degree of familiarity of the patient with the connected tools, and therefore will not necessarily be applicable to the entire population of obese patients without the risks of having a significant lack of follow-up during the first postoperative days.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Toulon, France, 83100
        • Centre Chirurgical d'Obesité

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with a BMI between 35 and 40 and comorbidity (type II diabetes, arterial hypertension, sleep apnea syndrome, dyslipidemia, fatty liver disease, arthropathy linked to overweight) related to obesity
  • Patients with a BMI greater than 40 with or without comorbidity
  • Patients affiliated to the social security scheme, with or without mutual health insurance
  • Collection of signed informed consent

  • Patients with one of the following sets of tools:

    • Computer tablet and computer with an internet connection
    • Computer tablet and smartphone with an internet connection
    • Smartphone and computer with an internet connection
  • Patients without a history of bariatric surgery
  • Patients with surgical indication for a sleeve gastrectomy

Exclusion Criteria:

  • Patients who have had obesity surgery
  • Patients who have the indication but want another surgery such as the sleeve
  • Patients who do not have an internet connection and / or an email address
  • Patients with a BMI less than 35
  • Patients with a major contraindication to surgery and / or American Society of Anesthesiologists (ASA) 4
  • Patients without social security
  • Patients refusing to sign consent
  • Patients living abroad and / or living more than two hours from the hospital
  • Minors or patients over 70 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Connected Tools
For the experimental group, the postoperative procedure requires the use of personal connected tools: a smartphone, a digital tablet or a computer with internet connection. A scale and a connected watch will also be loaned to patients so that they can take the necessary measures. Before returning home, patients must be trained to take correct measures and inform them on the dedicated platform.
Procedure: Connected tools
Use of connected tools in postoperative bariatric follow-up vs no use of connected tools.
No Intervention: No Connected Tools
Patients randomized to the control group will be operated according to the same protocol as the experimental group. For them, there will be no home follow-up, so no special procedure to follow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication Rate measured at 30 days.
Time Frame: 30 days after gastrectomy intervention.
The complication rate will be compared in the both treatment groups.
30 days after gastrectomy intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of lost to follow-up at 3 years.
Time Frame: 3 years after gastrectomy intervention/
The rate of lost to follow-up will be compared in the both treatment groups.
3 years after gastrectomy intervention/
Change in the lost to follow-up rate at 1 year.
Time Frame: 1 year after gastrectomy intervention.
In order to evaluate the evolution of the lost to follow-up, the change from baseline will be analyzed between the two treatment groups.
1 year after gastrectomy intervention.
Change in the lost to follow-up rate at 2 years.
Time Frame: 2 years after gastrectomy intervention.
In order to evaluate the evolution of the lost to follow-up, the change from baseline will be analyzed between the two treatment groups.
2 years after gastrectomy intervention.
Change in the loss to follow-up rate at 3 years.
Time Frame: 3 years after gastrectomy intervention.
In order to evaluate the evolution of the lost to follow-up, the change from baseline will be analyzed between the two treatment groups.
3 years after gastrectomy intervention.
Patient satisfaction regarding the use of tools.
Time Frame: 15 days after gastrectomy intervention.
A satisfaction questionnaire adapted to the study will be presented to patients in order to evaluate the satisfaction of tools' using, only for experimental group.
15 days after gastrectomy intervention.
Quality of life assessment at 3 months.
Time Frame: 3 months after gastrectomy intervention.
The BAROS quality of life questionnaire will be presented to patients in order to evaluate the quality of life.
3 months after gastrectomy intervention.
Quality of life assessment at 6 months.
Time Frame: 6 months after gastrectomy intervention.
The BAROS quality of life questionnaire will be presented to patients in order to evaluate the quality of life.
6 months after gastrectomy intervention.
Quality of life assessment at 12 months.
Time Frame: 12 months after gastrectomy intervention.
The BAROS quality of life questionnaire will be presented to patients in order to evaluate the quality of life.
12 months after gastrectomy intervention.
Post-operative complications at 3 months
Time Frame: 3 months after gastrectomy intervention.
The post-operative complications will be collected in both groups to evaluate the complication rate.
3 months after gastrectomy intervention.
Post-operative complications at 6 months
Time Frame: 6 months after gastrectomy intervention.
The post-operative complications will be collected in both groups to evaluate the complication rate.
6 months after gastrectomy intervention.
Post-operative complications at 12 months
Time Frame: 12 months after gastrectomy intervention.
The post-operative complications will be collected in both groups to evaluate the complication rate.
12 months after gastrectomy intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elsan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2020

Primary Completion (Actual)

April 5, 2022

Study Completion (Anticipated)

March 5, 2025

Study Registration Dates

First Submitted

April 14, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 15, 2021

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Dr CARANDINA
  • 2019-A01371-56 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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