Follow-up of Bariatric Surgery by Teleconsultations

NCT04497259 | Recruiting

• 1 other identifier: RC31/19/0128
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

bariatric surgery; follow-up; tele-evaluations; e-medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Coefficient evaluation

  month 12

• Consultation measure

  month 6 and 9

• Composite distribution

  month 12

• Consultation feeling

  Month 6 and 9

• Consultation feasability

  month 6 and 9

Study Arms (2)

Interventional

EXPERIMENTAL

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; Other: Teleconsultation

Control

EXPERIMENTAL

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; Other: Classical consultation

Interventions

Teleevaluation OTHER

Patients will answer to a questionnaire filled through a chatbot link

Control; Interventional

Teleconsultation OTHER

A teleconsultation (skype-like connection) at 6 and 9 months after surgery

Interventional

Classical consultation OTHER

Patients in the consultation arm will benefit from a classical face to face consultation at 6 and 9 months after surgery.

Control

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Ritz

Toulouse, Toulouse, 31000, France

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Remote Consultation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Referral and Consultation; Professional Practice; Organization and Administration; Health Services Administration; Telemedicine; Delivery of Health Care; Patient Care Management

Study Officials

• Patrick RITZ, Md

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick RITZ, MD

CONTACT

05 61 32 30 48; ritz.p@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: August 4, 2020
• Study Start: May 26, 2023
• Primary Completion: February 26, 2025
• Study Completion: February 26, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)