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

Bariatric Surgery Candidate Clinical Trial

— SPOC  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05176587
• Other study ID #: SPOC Study
• Secondary ID: 2021-A01847-34
• Status: Withdrawn
• Start date: December 1, 2022
• Est. completion date: December 2029

Study information

• Verified date: February 2024
• Source: Elsan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2029
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Other:
• Follow-up of patients undergoing bariatric surgery : integrated pathway
Integrated pathway : multidisciplinary, pre- and post-operative, care course for patients undergoing bariatric surgery

Locations

Country	Name	City	State
France	ELSAN	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Elsan	Cemka-Eval

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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