OAGB-MGB Conversions for Post-operative Complications

Completed

• Conditions: Bariatric Surgery Candidate

• Registration Number: NCT04641715
• Lead Sponsor: Federico II University

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.

Study Timeline

• Status Verified: 2020-11
• Study Start: 2020-11-01
• Primary Completion: 2020-11-17
• Study Completion: 2020-11-17
• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-24
• Last Update Submitted: 2020-11-27
• Last Update Posted: 2020-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Nunzio Velotti; 🇮🇹 Naples, Italy