Follow-up of Bariatric Surgery by Teleconsultations (TELECHIRO)

Using Tele-evaluation and Teleconsultation Instead of Classical Consultation for the Follow-up of Obese Patients After Bariatric Surgery : a Pilot Study.

An organised follow-up is required after bariatric surgery, but 50% of patients are lost to follow-up after 2 years. To design a large randomized clinical trial (RCT) comparing teleevaluations and teleconsultations to classical follow, aiming to prove that the quality of the follow-up is maintained and the patient-experience is improved, at a lower cost in people living far from the reference centre, this pilot study aims at describing the distribution of the collected criteria.

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Other: Teleevaluation; Other: Teleconsultation; Other: Classical consultation

Detailed Description

An organised follow-up is required after bariatric surgery, but 50% of patients are lost to follow-up after 2 years. This follow-up requires about 5 multi-professional evaluations during the first year. This can be cumbersome in patients living far from the reference centre and who may perceive the necessary time, cost and lost of income, and constraints as imbalanced. Teleevaluations and teleconsultations may solve this issue by replacing some of the classical evaluations (at 6 and 9 months). An RCT would be necessary, and a pilot study is proposed to describe the distribution of the judgment criteria.

This pilot study aims at describing all the parameters necessary to build an RCT, and involves the randomisation of operated patients recruited 3 months after surgery, in to groups. One will have the classical follow-up (venue and consultations at 6 and 9 months) the over will have teleevaluations and teleconsultations ; the parameters will be described at 12 months. The teleevaluation is either proposed as usual (a file is sent by secure mail) or by chatbot interaction. The consultation and the teleconsultation are based on the standard of care scenario.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse
    • Toulouse, Toulouse, France, 31000
      • Ritz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adults having had bariatric surgery 3 months before
• able to use an internet tool of chatbot and skype-like secured connection
• adult under 60 years old
• free inform and sign consent
• living more than 50km from Toulouse
• persons with social security

Exclusion Criteria:

• complications at the 3rd month post-surgery requiring specific care
• insufficient internet connection
• minor
• pregnant women
• protected adults
• people in emergency
• people unable to give consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; Patients in the teleconsultation arm will benefit from a tele-evaluation (a questionnaire filled through a chatbot link) and teleconsultation (skype-like connection) at 6 and 9 months after surgery.	Other: Teleevaluation; Patients will answer to a questionnaire filled through a chatbot link; Other: Teleconsultation; A teleconsultation (skype-like connection) at 6 and 9 months after surgery
Experimental: Control; Patients in the consultation arm will benefit from a tele-evaluation (a questionnaire filled at home after the file was sent by secured mail) and a classical face to face consultation at 6 and 9 months after surgery.	Other: Teleevaluation; Patients will answer to a questionnaire filled through a chatbot link; Other: Classical consultation; Patients in the consultation arm will benefit from a classical face to face consultation at 6 and 9 months after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite score research	Look for the composite follow-up quality score taking into account weighting results, co-morbidities, absence of complications and skill acquisition.	month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coefficient evaluation	Coefficient of variation and Cronbach's coefficient assessing the quality of the composite follow-up quality score	month 12
Consultation measure	the time of a teleconsultation and a face-to-face consultation, by an objective measurement of this time at 6 and 9 months postoperatively	month 6 and 9
Composite distribution	the distribution of each of the components of the Composite Follow-up Quality Score in the two arms of the study	month 12
Consultation feeling	satisfaction and constraints felt with regard to teleconsultations, by scores measured at teleconsultations and consultation at 6 and 9 months post-operatively	Month 6 and 9
Consultation feasability	the feasibility of teleconsultation and consultation with scores measured at 6 and 9 months post-operatively	month 6 and 9

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Patrick RITZ, Md, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2023
• Primary Completion (Actual): July 22, 2024
• Study Completion (Actual): July 22, 2024

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: bariatric surgery; follow-up; tele-evaluations; e-medicine
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Referral and Consultation; Professional Practice; Organization and Administration; Health Services Administration; Delivery of Health Care; Telemedicine; Patient Care Management; Remote Consultation
• Other Study ID Numbers: RC31/19/0128

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No