OAGB-MGB Conversions for Post-operative Complications | NCT04641715

Studies
OAGB-MGB Conversions for Post-operative Complications

NCT04641715

Sponsor

Federico II University

Status

Completed

Last Update Posted

Dec 1, 2020Actual

Enrollment

207Actual

Phase

Not provided

Conditions

Bariatric Surgery Candidate

Interventions

OAGB-MGB

Countries

Italy

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

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2020Actual

Primary Completion Date

Nov 17, 2020Actual

Completion Date

Nov 17, 2020Actual

First Submitted Date

Nov 18, 2020

First Submission Date that Met QC Criteria

Nov 18, 2020

First Posted Date

Nov 24, 2020Actual

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

Nov 27, 2020

Last Update Posted Date

Dec 1, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mario Musella MD, Full Professor, Federico II UniversityPrincipal Investigator

Lead Sponsor

Federico II UniversityOTHER

Collaborators

Not provided

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

Laparoscopic mini/one anastomosis gastric bypass (MGB/OAGB) is a relatively new bariatric procedure and is gaining ground over the surgical approach for morbid obesity as a safe and effective operation. Revision of MGB/OAGB was never studied before as multicenter data collection: we collected data from 21 italian centers who perform MGB/OAGB to evaluate patients' conditions which determinated the conversion from this procedure to another kind of bariatric technique.

Detailed Description

MGB / OAGB has been shown to be an effective and safe bariatric technique. Despite that, the complications of this procedure have already been extensively described in the literature. Our goal is to collect data from 21 Italian centers that practice MGB / OAGB to evaluate the reasons and complications that led surgeons to revise this surgery with a subsequent bariatric procedure. For this reason we have analyzed the data provided by the centers on 8676 patients undergoing MGB / OAGB, focusing attention on phenomena such as GERD, anastomotic stenosis, bleeding and marginal ulcers which are the most frequent causes of re-intervention. We also evaluated the changes in BMI between the primary procedure and the revision procedure to ensure that the bariatric purpose of the surgical program was maintained.

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

207Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OAGB-MGB	Procedure	One Anastomosis Gastric Bypass - Mini Gastric Bypass as both restrictive and malabsorptive bariatric procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reasons for Conversion from MGB/OAGB to other bariatric procedures	We evaluated the reasons for conversion from MGB/OAGB in terms of late post-operative complications.	From 2006 to 2020
Surgical type of conversion from MGB/OAGB	We evaluated the type of bariatric revisional procedure performed in each patient underwent to MGB/OAGB	From 2006 to 2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients underwent to OAGB-MGB who needed conversion to other bariatric procedure

Exclusion Criteria:

Patients underwent to OAGB-MGB who needed conversion to other bariatric procedure in emergency within 48/72 hours after the first surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients elegible for conversion from OAGB-MGB to other bariatric procedures

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mario Musella, Full Professor	Federico II University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nunzio Velotti		Naples		80131	Italy

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