Clinical and Economic Outcomes in Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Surgery
NCT ID: NCT01754194
Last Updated: 2017-07-07
Study Results
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View full resultsBasic Information
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COMPLETED
293 participants
OBSERVATIONAL
2012-04-30
2014-10-31
Brief Summary
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1. generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery
2. support multi-disciplinary bariatric sites in Germany by providing structured procedure guidelines and training, therefore facilitating procedural adoption, increasing safety and shortening the learning curve for weight-loss surgery.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Procedure Type 1
Gastric Sleeve Resection
Gastric Sleeve Resection
Laparoscopic Gastric Sleeve Resection
Procedure Type 2
Roux-en-Y Gastric Bypass
Roux-en-Y Gastric Bypass
Laparoscopic Roux-en-Y Gastric Bypass
Interventions
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Gastric Sleeve Resection
Laparoscopic Gastric Sleeve Resection
Roux-en-Y Gastric Bypass
Laparoscopic Roux-en-Y Gastric Bypass
Eligibility Criteria
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Inclusion Criteria
* BMI \> 40 or BMI \> 35 with co-morbidities
* Eligible for weight-loss surgery
* Planned laparoscopic gastric sleeve resections or Roux-en-Y bypass surgery
* Insurance approval status: approved
* Written informed consent
Exclusion Criteria
* Planned two-stage procedures
* Prior bariatric procedures (including gastric banding)
* Serious mental or physical co-morbidities at the discretion of the Investigator
* Insurance approval status: rejected
18 Years
65 Years
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
Responsible Party
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Principal Investigators
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Oliver Mann, MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinik Hamburg Eppendorf
Locations
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Krankenhaus Bad Cannstatt
Bad Cannstatt, , Germany
Bundeswehr Krankenhaus Berlin
Berlin, , Germany
Franziskus Hospital Bielefeld
Bielefeld, , Germany
BHV-Reinikenheide
Bremerhaven, , Germany
Amperklinikum Dachau
Dachau, , Germany
Kreiskrankenhaus Emmendingen
Emmendingen, , Germany
Universitätsklinik Hamburg Eppendorf
Hamburg, , Germany
Ev. Krankenhaus Herne
Herne, , Germany
Klinikum Itzehoe
Itzehoe, , Germany
Marienkrankenhaus Kassel
Kassel, , Germany
Krankenhaus Luebbecke
Lübbecke, , Germany
Sana Klinikum Lübeck
Lübeck, , Germany
Diakoniekrankenhaus Mannheim
Mannheim, , Germany
Krankenhaus Hetzelstift Neustadt/Weinstraße
Neustadt, , Germany
Thüringen-Kliniken "Georgius Agricola"
Saalfeld, , Germany
Diakonie-Klinikum Schwäbisch Hall
Schwäbisch Hall, , Germany
Schwarzwald Baar Klinikum Villingen
Villingen, , Germany
Krankenhaus Winsen
Winsen, , Germany
Countries
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References
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Wolter S, Dupree A, ElGammal A, Runkel N, Heimbucher J, Izbicki JR, Mann O, Busch P. Mentorship Programs in Bariatric Surgery Reduce Perioperative Complication Rate at Equal Short-Term Outcome-Results from the OPTIMIZE Trial. Obes Surg. 2019 Jan;29(1):127-136. doi: 10.1007/s11695-018-3495-2.
Other Identifiers
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COVMBSG0167
Identifier Type: -
Identifier Source: org_study_id
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