NCT04641715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 18, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

16 days

First QC Date

November 18, 2020

Last Update Submit

November 27, 2020

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

OAGB-MGBPROCEDURE

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nunzio Velotti

Naples, 80131, Italy

Location

Study Officials

  • Mario Musella, Full Professor

    Federico II University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

November 18, 2020

First Posted

November 24, 2020

Study Start

November 1, 2020

Primary Completion

November 17, 2020

Study Completion

November 17, 2020

Last Updated

December 1, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)