MGB/OAGB Versus RYGB After Failed Sleeve

September 29, 2018 updated by: Sonja Chiappetta, MD, Sana Klinikum Offenbach

A Comparison of the Mini/One Anastomosis-Gastric Bypass and Roux-en-Y Gastric Bypass for Conversion of Failed Sleeve Gastrectomy

Sleeve Gastrectomy is the most performed bariatric procedure worldwide. But a growing number of data documents that some patients have to be surgical revised due to weight regain or gastro-esophageal reflux disease.

This study elaborates weather Roux-en-Y gastric bypass (RYGB) or Mini/One anastomosis gastric bypass (MGB/OAGB) is a better second step procedure after failed sleeve gastrectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients who underwent RYGB or MGB/OAGB between October 2014 and December 2016 after failed sleeve gastrectomy will be recorded and analyzed in relation to weight loss, intra- and postoperative complications (Clavien-Dindo) and postoperative morbidity up to one year follow-up.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Offenbach Am Main
      • Offenbach, Offenbach Am Main, Germany, 63069
        • Sana Klinikum Offenbach

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with failed sleeve due to

  • weight regain
  • weight loss failure
  • gastro-esophageal reflux disease Grade B

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Failed sleeve gastrectomy - RNYGB
Intervention: Roux en Y gasric bypass (RNYGB)
Procedure: Roux en Y gastric bypass
Laparoscopic Roux en Y gastric bypass (150 cm alimentary limb, 50 cm biliopancreaty limb)
Other Names:
  • RNYGB
Other: Failed sleeve gastrectomy - MGB/OAGB
Inervention: Mini/One anastomosis gasic bypass (MGB/OAGB)
Procedure: Mini/One anastomosis gastric bypass
Laparoscopic Mini/One anastomosis gastric bypass (200 cm biliopancreatic limb)
Other Names:
  • MGB/OAGB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Loss
Time Frame: 1 year follow-up
Total Body Weight Loss in %
1 year follow-up
Weight Loss
Time Frame: 1 year follow-up
Excess Weight Loss in %
1 year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative Complications
Time Frame: up to 30 days postsurgery
Perioperative Complications (Clavin-Dindo)
up to 30 days postsurgery
Postoperative Morbidity
Time Frame: 1 year follow-up
Postoperative Morbidity
1 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sana Klinikum Offenbach

Investigators

  • Principal Investigator: Sonja Chiappetta, MD, Sana Klinikum Offenbach

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

April 23, 2018

First Submitted That Met QC Criteria

May 3, 2018

First Posted (Actual)

May 16, 2018

Study Record Updates

Last Update Posted (Actual)

October 2, 2018

Last Update Submitted That Met QC Criteria

September 29, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF 3/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Anonymous data will be published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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