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Place of Connected Tools in Bariatric Patients Follow-up.

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ClinicalTrials.gov Identifier: NCT04847037
Recruitment Status : Recruiting
First Posted : April 15, 2021
Last Update Posted : May 14, 2021
Sponsor:
Information provided by (Responsible Party):
Sergio CARANDINA, Elsan

Study Description
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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).

Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Procedure: Connected tools Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a pilot, prospective, single-center, comparative, randomized, open-label study.
Masking: None (Open Label)
Masking Description: The experimental group which will use the connected tools will be compared with the control group according to the usual procedure.
Primary Purpose: Prevention
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?
Actual Study Start Date : March 5, 2020
Estimated Primary Completion Date : April 5, 2022
Estimated Study Completion Date : March 5, 2025
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Complication Rate measured at 30 days. [ Time Frame: 30 days after gastrectomy intervention. ]
    The complication rate will be compared in the both treatment groups.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04847037


Contacts
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Contact: Sergio CARANDINA, MD (0)6 77 59 39 54 ext +33 sergio.carandina@gmail.com

Locations
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France
Centre Chirurgical d'Obesité Recruiting
Toulon, France, 83100
Contact: Sergio CARANDINA, MD    (0)6 77 59 39 54 ext +33    sergio.carandina@gmail.com   
Sponsors and Collaborators
Sergio CARANDINA
More Information
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Publications:

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Responsible Party: Sergio CARANDINA, Dr Sergio CARANDINA, Elsan
ClinicalTrials.gov Identifier: NCT04847037    
Other Study ID Numbers: Dr CARANDINA
2019-A01371-56 ( Other Identifier: ANSM )
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: May 14, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No