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

Medical and Medico-economic Evaluation Comparing the Follow-up of Patients Undergoing Bariatric Surgery (SPOC Study (Suivi Parcours Obésité en Chirurgie))

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

Study Overview

• Status: Withdrawn
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Other: Follow-up of patients undergoing bariatric surgery : integrated pathway

• Study Type: Observational

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Elsan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing bariatric surgery

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group
Integrated group (SPOC)	Other: Follow-up of patients undergoing bariatric surgery : integrated pathway; Integrated pathway : multidisciplinary, pre- and post-operative, care course for patients undergoing bariatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Elsan
• Collaborators: Cemka-Eval

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SPOC Study; 2021-A01847-34 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No