Trial document




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  DRKS00004766

Trial Description

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Title

BariSurg- Sleeve gastrectomy versus Roux-en-Y gastric bypass in obese patients with BMI 35-60 kg/m² - a multicenter randomized trial

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Trial Acronym

BariSurg

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URL of the Trial

http://none

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Brief Summary in Lay Language

The study compares excess weight loss after two and five years, morbidity, mortality, course of obesity related disease, course of gastrooesophageal reflux diseases and quality of life in patients with a BMI of 35-60 kg / kg² after 2 different surgical procedures in obesity surgery (sleeve gastrectomy and gastric bypass).

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Brief Summary in Scientific Language

Comparison between sleeve gastrectomy and Roux-en-Y gastric bypass operations on excess weight loss after two and five years, morbidity, mortality, obesity related co-morbidities, gastrooesophageal reflux disease and quality of life.

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Organizational Data

  •   DRKS00004766
  •   2013/03/18
  •   [---]*
  •   yes
  •   Approved
  •   S-500/2012, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E66.0 -  Obesity due to excess calories
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Interventions/Observational Groups

  •   gastric bypass (gastrojejunostomie and Roux-en Y jejunojejunostomie)
  •   Sleeve gastrectomy
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

excess weight loss two years after surgery

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Secondary Outcome

- Excess weight loss after 5 years
- occurrence of gastroesophageal reflux desease (GIQLI, GSRS, gastro-oesophagoduodenoscopy, preoperatively, 24 months and 60 months after surgery)
-course of obesity related disease, morbidity and mortality (case history, blood findings, apparative diagnostics, preoperatively, at discharge, 3-6, 12 months postoperatively, and then once a year)
- Quality of life (SF 36, preoperatively, 24 und 60 months postoperatively)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2013/11/27
  •   248
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

Age, BMI 35-60 kg/m² according to the German S3 guidelines, preoperative psychosomatic and endocrinological investigation without contraindication to bariatric surgery, signed Informed consent

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Exclusion Criteria

Pregnancy, malignant disease in the past five years. Expected lack of compliance or inability to informed consent, ASA IV, previous bariatric surgery, History of major abdominal operation

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg Sektion Minimal Invasive CHirurgie
    • Mr.  Prof. Dr.med.  Lars  Fischer 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg Sektion Minimal Invasive CHirurgie
    • Mr.  Prof. Dr.med.  Lars  Fischer 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.