Clinical trial NCT04847037: Place of Connected Tools in Bariatric Patients Follow-up.
Official title: 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?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bariatric Surgery Candidate
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pilot, prospective, single-center, comparative, randomized, open-label study.
Primary purpose: PREVENTION

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complication Rate measured at 30 days.
timeFrame: 30 days after gastrectomy intervention.
Secondary outcomes:
measure: Rate of lost to follow-up at 3 years.
timeFrame: 3 years after gastrectomy intervention/
measure: Change in the lost to follow-up rate at 1 year.
timeFrame: 1 year after gastrectomy intervention.
measure: Change in the lost to follow-up rate at 2 years.
timeFrame: 2 years after gastrectomy intervention.
measure: Change in the loss to follow-up rate at 3 years.
timeFrame: 3 years after gastrectomy intervention.
measure: Patient satisfaction regarding the use of tools.
timeFrame: 15 days after gastrectomy intervention.
measure: Quality of life assessment at 3 months.
timeFrame: 3 months after gastrectomy intervention.
measure: Quality of life assessment at 6 months.
timeFrame: 6 months after gastrectomy intervention.
measure: Quality of life assessment at 12 months.
timeFrame: 12 months after gastrectomy intervention.
measure: Post-operative complications at 3 months
timeFrame: 3 months after gastrectomy intervention.
measure: Post-operative complications at 6 months
timeFrame: 6 months after gastrectomy intervention.
measure: Post-operative complications at 12 months
timeFrame: 12 months after gastrectomy intervention.
Other outcomes:
Locations:
city: Toulon
country: France
facility: Centre Chirurgical d'Obesité
Study officials:
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