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Banded Versus Non-banded Roux-en-Y Gastric Bypass

This study is currently recruiting participants.
Verified November 2009 by Medical University of Vienna
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01078181
First received: March 1, 2010
Last updated: June 23, 2010
Last verified: November 2009
History of Changes
  Purpose

This is a prospective randomized Study comparing Weight loss, Esophageal Motility and Reflux in lap. Gastric Bypass vs. lap. Banded-Gastric Bypass using the A.M.I. Soft Gastric Bypass Band (B-Band.


Condition Intervention
Morbid Obesity
 Procedure: gastric bypass

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Comparison on Weight Loss After Gastric Bypass and Banded Gastric Bypass Using the A.M.I B-Band (Soft Gastric Bypass Band)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Excessive Weight Loss [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pouch dilatation, band migration, reflux, esophageal motility [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Pouch dilatation verified by double contrast upper GI series Band migrations verified by gastroscopy Reflux verifies by pH-metry and gastroscopy Esophageal motility measured by manomerty


Estimated Enrollment: 100
Study Start Date: November 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: banded gastric bypass
Banded gastric bypass (circular anastomosis 21mm) using the A.M.I. B-Band (Soft Gastric Bypass Band)
 Procedure: gastric bypass
laparoscopic gastric bypass with circular stapled 21mm gastrojejunostomy
Other Names:
  • laparoscopic gastric bypass
  • laparoscopic banded gastric bypass
Active Comparator: non-banded gastric bypass
non-banded gastric bypass (circular anastomosis 21mm)
 Procedure: gastric bypass
laparoscopic gastric bypass with circular stapled 21mm gastrojejunostomy
Other Names:
  • laparoscopic gastric bypass
  • laparoscopic banded gastric bypass

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI > 40 or BMI > 35 + hypertension/diabetes mellitus
  • pH metry and manometry preoperatively

Exclusion Criteria:

  • formerly operations of the stomach
  • formerly open abdominal surgery
  • malignancy within the last 5 years
  • formerly gastric banding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078181

Contacts
Contact: Gerhard Prager, M.D. +43-1-40400 ext 5621 gerhard.prager@meduniwien.ac.at
Contact: Felix B Langer, M.D. +43-1-40400 ext 5621 felix.langer@meduniwien.ac.at

Locations
Austria
Medical University of Vienna, Department of Surgery Recruiting
Vienna, Austria, 1090
Contact: Gerhard Prager, M.D.     +43-1-40400 ext 5621     gerhard.prager@meduniwien.ac.at    
Contact: Felix B Langer, M.D.     +43-1-40400 ext 5621     felix.langer@meduniwien.ac.at    
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Gerhard Prager, M.D. Medical University of Vienna, Department of Surgery
  More Information

No publications provided

Responsible Party: Gerhard Prager / M.D., Medical University of Vienna / Department of Surgery
ClinicalTrials.gov Identifier: NCT01078181     History of Changes
Other Study ID Numbers: MUW ADIP STUDY 15, Banded Bypass Study 15
Study First Received: March 1, 2010
Last Updated: June 23, 2010
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
gastric bypass
banded gastric bypass
weight loss
weight regain
bariatric surgery

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013