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

Not Applicable

• Conditions: Morbid Obesity
• Interventions: Procedure: gastric bypass

• Registration Number: NCT01078181
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-11
• Study Start: 2009-11
• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Last Update Submitted: 2010-06-23
• Last Update Posted: 2010-06-24
• Primary Completion: 2014-05
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
banded gastric bypass	gastric bypass	Banded gastric bypass (circular anastomosis 21mm) using the A.M.I. B-Band (Soft Gastric Bypass Band)
non-banded gastric bypass	gastric bypass	non-banded gastric bypass (circular anastomosis 21mm)

Primary Outcome Measures

Name	Time	Method
Excessive Weight Loss	3 years

Secondary Outcome Measures

Name	Time	Method
pouch dilatation, band migration, reflux, esophageal motility	3 years	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

Trial Locations

Locations (1)

Medical University of Vienna, Department of Surgery; 🇦🇹 Vienna, Austria