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

NCT05176587 | Withdrawn

• 2 other identifiers: SPOC Study2021-A01847-34
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• Bariatric revision surgery at 5 years follow-up

  Proportion of subjects who will have a bariatric revision surgery at 5 years follow-up

  5 years after the first surgery

Study Arms (2)

Integrated group (SPOC)

Other: Follow-up of patients undergoing bariatric surgery : integrated pathway

Control group

Interventions

Follow-up of patients undergoing bariatric surgery : integrated pathway OTHER

Integrated pathway : multidisciplinary, pre- and post-operative, care course for patients undergoing bariatric surgery

Integrated group (SPOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing bariatric surgery

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Protected patient : adult under tutorship, curatorship or other legal protection, deprived of his freedom by judiciary or administrative decision;
• Patient hospitalised without consent

Sponsors & Collaborators

• Elsan: lead
• Cemka-Eval: collaborator

Study Sites (1)

ELSAN

Paris, France

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 4, 2022
• Study Start: December 1, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)