Medical and Medico-economic Evaluation Comparing the Foll... | NCT05176587

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

NCT05176587

Sponsor

Elsan

Status

Withdrawn

Last Update Posted

Feb 28, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Bariatric Surgery Candidate

Interventions

Follow-up of patients undergoing bariatric surgery : integrated pathway

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2021-A01847-34	Other Identifier	ID-RCB

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

the deployment of the integrated pathwat takes longer than expected

Expanded Access Info

Start Date

Dec 1, 2022Actual

Primary Completion Date

Dec 2028Estimated

Completion Date

Dec 2029Estimated

First Submitted Date

Dec 21, 2021

First Submission Date that Met QC Criteria

Jan 3, 2022

First Posted Date

Jan 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2024

Last Update Posted Date

Feb 28, 2024Actual

Name	Class
Cemka-Eval	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Integrated group (SPOC)			Other: Follow-up of patients undergoing bariatric surgery : integrated pathway
Control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Follow-up of patients undergoing bariatric surgery : integrated pathway	Other	Integrated pathway : multidisciplinary, pre- and post-operative, care course for patients undergoing bariatric surgery

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients undergoing bariatric surgery

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided