Place of Connected Tools in Bariatric Patients Follow-up.

NCT04847037 | Unknown

• 2 other identifiers: Dr CARANDINA2019-A01371-56
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• Complication Rate measured at 30 days.

  The complication rate will be compared in the both treatment groups.

  30 days after gastrectomy intervention.

Secondary Outcomes (11)

• Rate of lost to follow-up at 3 years.

  3 years after gastrectomy intervention/

• Change in the lost to follow-up rate at 1 year.

  1 year after gastrectomy intervention.

• Change in the lost to follow-up rate at 2 years.

  2 years after gastrectomy intervention.

• Change in the loss to follow-up rate at 3 years.

  3 years after gastrectomy intervention.

• Patient satisfaction regarding the use of tools.

  15 days after gastrectomy intervention.

Study Arms (2)

Connected Tools

EXPERIMENTAL

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

No Connected Tools

NO INTERVENTION

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.

Interventions

Connected tools PROCEDURE

Use of connected tools in postoperative bariatric follow-up vs no use of connected tools.

Connected Tools

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Centre Chirurgical d'Obesité

Toulon, 83100, France

Location

Related Publications (32)

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The experimental group which will use the connected tools will be compared with the control group according to the usual procedure.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot, prospective, single-center, comparative, randomized, open-label study.

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 15, 2021
• Study Start: March 5, 2020
• Primary Completion: April 5, 2022
• Study Completion: March 5, 2025
• Last Updated: May 18, 2023

Record last verified: 2023-05

Locations

FR (1)