Medical and Medico-economic Evaluation Comparing the Follow-up of Patients Undergoing Bariatric Surgery

Withdrawn

• Conditions: Bariatric Surgery Candidate

• Registration Number: NCT05176587
• Lead Sponsor: Elsan

Brief Summary

Study design :

Prospective, longitudinal, observational (non-interventional), multicenter, comparative medico-economic study - RIPH2, with direct matching to SNDS data (National Health Data System)

Main objective :

To evaluate the effectiveness of a multidisciplinary, pre- and post-operative, care course for patients undergoing bariatric surgery

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-04
• Study Start: 2022-12-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2028-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Inclusion criteria for the Integrated group (SPOC)

  • Patient, male or female, at least 18 years old;
  • Patient undergoing bariatric surgery after the implementation of the integrated pathway (date depending on the deployment of the integrated pathway);
  • Patient informed and not objecting to this research;
  • Subject affiliated to or benefiting from a social security program.

• Inclusion criteria for the control group

  • Patient, male or female, at least 18 years old;
  • Patient undergoing bariatric surgery before the implementation of the integrated pathway (date depending on the deployment of the integrated pathway);
  • Patient informed and not objecting to this research;
  • Subject affiliated to or benefiting from a social security program.

Exclusion Criteria

• • Protected patient : adult under tutorship, curatorship or other legal protection, deprived of his freedom by judiciary or administrative decision;

  • Patient hospitalised without consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bariatric revision surgery at 5 years follow-up	5 years after the first surgery	Proportion of subjects who will have a bariatric revision surgery at 5 years follow-up

Trial Locations

Locations (1)

ELSAN; 🇫🇷 Paris, France