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OpenTrials
Completed

NCT Number: NCT04641715

OAGB-MGB Conversions for Post-operative Complications

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.

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Key information

Conditions

Bariatric Surgery Candidate

Sex eligibility

All sexes

Study type

Observational

Primary location

Nunzio Velotti

Naples, 80131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OAGB-MGB

Procedure

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

Primary outcomes

  1. Reasons for Conversion from MGB/OAGB to other bariatric procedures

    Time frame: From 2006 to 2020

    We evaluated the reasons for conversion from MGB/OAGB in terms of late post-operative complications.

  2. Surgical type of conversion from MGB/OAGB

    Time frame: From 2006 to 2020

    We evaluated the type of bariatric revisional procedure performed in each patient underwent to MGB/OAGB

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

OAGB-MGB Conversion for Failed Procedure: a Multicenter Italian Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 24, 2020
Registry last updated
Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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