Place of Connected Tools in Bariatric Patients Follow-up.
NCT ID: NCT04847037
Last Updated: 2023-05-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
200 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-03-05
Study Completion Date
2025-03-05
Brief Summary
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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).
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Detailed Description
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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.
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.
Conditions
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Bariatric Surgery Candidate
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
This is a pilot, prospective, single-center, comparative, randomized, open-label study.
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
The experimental group which will use the connected tools will be compared with the control group according to the usual procedure.
Study Groups
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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.
Group Type
EXPERIMENTAL
Connected tools
Intervention Type
PROCEDURE
Use of connected tools in postoperative bariatric follow-up vs no use of connected tools.
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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Connected tools
Use of connected tools in postoperative bariatric follow-up vs no use of connected tools.
Intervention Type
PROCEDURE
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Elsan
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Centre Chirurgical d'Obesité
Toulon, , France
Site Status
Countries
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France
References
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Reference Type
BACKGROUND
Other Identifiers
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2019-A01371-56
Identifier Type: OTHER
Identifier Source: secondary_id
Dr CARANDINA
Identifier Type: -
Identifier Source: org_study_id
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