Place of Connected Tools in Bariatric Patients Follow-up.

Bariatric Surgery Candidate Clinical Trial

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?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04847037
• Other study ID #: Dr CARANDINA
• Secondary ID: 2019-A01371-56
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 5, 2020
• Est. completion date: March 5, 2025

Study information

• Verified date: May 2023
• Source: Elsan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 5, 2025
• Est. primary completion date: April 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Procedure:
• Connected tools
Use of connected tools in postoperative bariatric follow-up vs no use of connected tools.

Locations

Country	Name	City	State
France	Centre Chirurgical d'Obesité	Toulon

Sponsors (1)

Lead Sponsor	Collaborator
Elsan

Country where clinical trial is conducted

France, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication Rate measured at 30 days.	The complication rate will be compared in the both treatment groups.	30 days after gastrectomy intervention.
Secondary	Rate of lost to follow-up at 3 years.	The rate of lost to follow-up will be compared in the both treatment groups.	3 years after gastrectomy intervention/
Secondary	Change in the lost to follow-up rate at 1 year.	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.
Secondary	Change in the lost to follow-up rate at 2 years.	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.
Secondary	Change in the loss to follow-up rate at 3 years.	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.
Secondary	Patient satisfaction regarding the use of tools.	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.
Secondary	Quality of life assessment at 3 months.	The BAROS quality of life questionnaire will be presented to patients in order to evaluate the quality of life.	3 months after gastrectomy intervention.
Secondary	Quality of life assessment at 6 months.	The BAROS quality of life questionnaire will be presented to patients in order to evaluate the quality of life.	6 months after gastrectomy intervention.
Secondary	Quality of life assessment at 12 months.	The BAROS quality of life questionnaire will be presented to patients in order to evaluate the quality of life.	12 months after gastrectomy intervention.
Secondary	Post-operative complications at 3 months	The post-operative complications will be collected in both groups to evaluate the complication rate.	3 months after gastrectomy intervention.
Secondary	Post-operative complications at 6 months	The post-operative complications will be collected in both groups to evaluate the complication rate.	6 months after gastrectomy intervention.
Secondary	Post-operative complications at 12 months	The post-operative complications will be collected in both groups to evaluate the complication rate.	12 months after gastrectomy intervention.