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OpenTrials
Completed

NCT Number: NCT03526783

MGB/OAGB Versus RYGB After Failed Sleeve

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sana Klinikum Offenbach

Offenbach, Offenbach Am Main, 63069, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with failed sleeve due to

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

Exclusion criteria

-

Treatment and study plan

Roux en Y gastric bypass

Procedure

Laparoscopic Roux en Y gastric bypass (150 cm alimentary limb, 50 cm biliopancreaty limb)

Other names: RNYGB

Mini/One anastomosis gastric bypass

Procedure

Laparoscopic Mini/One anastomosis gastric bypass (200 cm biliopancreatic limb)

Other names: MGB/OAGB

Primary outcomes

  1. Weight Loss

    Time frame: 1 year follow-up

    Total Body Weight Loss in %

  2. Weight Loss

    Time frame: 1 year follow-up

    Excess Weight Loss in %

Secondary outcomes

  1. Perioperative Complications

    Time frame: up to 30 days postsurgery

    Perioperative Complications (Clavin-Dindo)

  2. Postoperative Morbidity

    Time frame: 1 year follow-up

    Postoperative Morbidity

Sponsors and collaborators

Lead sponsor

Sana Klinikum Offenbach

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
May 16, 2018
Registry last updated
Oct 2, 2018

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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