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NCT01078181 Clinical Trial

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

Morbid Obesity Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01078181
Other study ID # MUW ADIP STUDY 15
Secondary ID Banded Bypass St
Status Recruiting
Phase N/A
First received March 1, 2010
Last updated June 23, 2010
Start date November 2009
Est. completion date May 2014

Study information
Verified date November 2009
Source Medical University of Vienna
Contact Gerhard Prager, M.D.
Phone +43-1-40400
Email gerhard.prager@meduniwien.ac.at
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• gastric bypass
laparoscopic gastric bypass with circular stapled 21mm gastrojejunostomy

Locations
Country Name City State
Austria Medical University of Vienna, Department of Surgery Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Excessive Weight Loss 3 years No
Secondary pouch dilatation, band migration, reflux, esophageal motility 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 3 years Yes
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