OAGB-MGB Conversions for Post-operative Complications

NCT ID: NCT04641715

Last Updated: 2020-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2020-11-17

Brief Summary

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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

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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.

Conditions

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Bariatric Surgery Candidate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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OAGB-MGB

One Anastomosis Gastric Bypass - Mini Gastric Bypass as both restrictive and malabsorptive bariatric procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Mario Musella MD

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mario Musella, Full Professor

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

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Nunzio Velotti

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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MGB Class

Identifier Type: -

Identifier Source: org_study_id