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Endoscopic Complications After Gastric Bypass

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03532646
Recruitment Status : Active, not recruiting
First Posted : May 22, 2018
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Sonja Chiappetta, MD, Sana Klinikum Offenbach

Brief Summary:
Endoscopic complications such as gastro-esophageal reflux disease, ulcera, gastritis, bile reflux, anastomotic stricture and so on are described after gastric bypass surgery. The incidence of these complications after RYGB versus MGB/OAGB are getting observed.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Bariatric Surgery Candidate Procedure: upper endoscopy Not Applicable

Detailed Description:
All patients who were readmitted to our centre of excellence for obesity and metabolic surgery (October 2014 - March 2018) are observed regarding endoscopic complications in s.a. RYGB and MGB/OAGB.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: All patients who underwent RYGB and MGB/OAGB readmitted for complications in our centre of excellence are getting observed
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Endoscopic Complications After Roux-en Y Gastric Bypass Versus Mini/One Anastomosis Gastric Bypass
Actual Study Start Date : October 2014
Actual Primary Completion Date : March 2018
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
group 1: RYGB
All patients who underwent RYGB and were readmitted to upper endoscopy are getting observed
Procedure: upper endoscopy
endoscopy of the gastrointestinal tract

group 2:MGB/OAGB
All patients who underwent MGB/OAGB and were readmitted to upper endoscopy are getting observed
Procedure: upper endoscopy
endoscopy of the gastrointestinal tract




Primary Outcome Measures :
  1. Complication [ Time Frame: Up to 15 years post surgery ]
    Pathological finding during upper endoscopy


Secondary Outcome Measures :
  1. Weight Loss since Surgery [ Time Frame: Up to 15 years post surgery ]
    Weight Loss since Surgery: Total Weight Loss in %

  2. toxic status [ Time Frame: Up to 15 years post surgery ]
    toxic status (NSAID)

  3. toxic status II [ Time Frame: Up to 15 years post surgery ]
    toxic status (nicotin)

  4. Revisional Surgery [ Time Frame: Up to 15 years post surgery ]
    Revisional Surgery due to complication



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients who underwent RYGB or MGB/OAGB as a primary surgery and were readmitted to tho hospital undergoing upper endoscopy are included

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532646


Sponsors and Collaborators
Sana Klinikum Offenbach
Investigators
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Principal Investigator: Sonja Chiappetta, MD Sana Klinikum Offenbach

Publications of Results:
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Responsible Party: Sonja Chiappetta, MD, Dr. med. Sonja Chiappetta, MD, senior consultant, principal investigator, Sana Klinikum Offenbach
ClinicalTrials.gov Identifier: NCT03532646     History of Changes
Other Study ID Numbers: FF 111/2016
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be published anonymous in a peer review journal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms