Back to resultsBanded Versus Non-banded Roux-en-Y Gastric Bypass
Primary Purpose
Morbid Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
gastric bypass
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring gastric bypass, banded gastric bypass, weight loss, weight regain, bariatric surgery
Eligibility 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
Sites / Locations
- Medical University of Vienna, Department of SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
banded gastric bypass
non-banded gastric bypass
Arm Description
Banded gastric bypass (circular anastomosis 21mm) using the A.M.I. B-Band (Soft Gastric Bypass Band)
non-banded gastric bypass (circular anastomosis 21mm)
Outcomes
Primary Outcome Measures
Excessive Weight Loss
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01078181
First Posted
March 1, 2010
Last Updated
June 23, 2010
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT01078181
Brief Title
Banded Versus Non-banded Roux-en-Y Gastric Bypass
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
gastric bypass, banded gastric bypass, weight loss, weight regain, bariatric surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
banded gastric bypass
Arm Type
Active Comparator
Arm Description
Banded gastric bypass (circular anastomosis 21mm) using the A.M.I. B-Band (Soft Gastric Bypass Band)
Arm Title
non-banded gastric bypass
Arm Type
Active Comparator
Arm Description
non-banded gastric bypass (circular anastomosis 21mm)
Intervention Type
Procedure
Intervention Name(s)
gastric bypass
Other Intervention Name(s)
laparoscopic gastric bypass, laparoscopic banded gastric bypass
Intervention Description
laparoscopic gastric bypass with circular stapled 21mm gastrojejunostomy
Primary Outcome Measure Information:
Title
Excessive Weight Loss
Time Frame
3 years
Secondary Outcome Measure Information:
Title
pouch dilatation, band migration, reflux, esophageal motility
Description
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
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerhard Prager, M.D.
Phone
+43-1-40400
Ext
5621
Email
gerhard.prager@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Felix B Langer, M.D.
Phone
+43-1-40400
Ext
5621
Email
felix.langer@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Prager, M.D.
Organizational Affiliation
Medical University of Vienna, Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna, Department of Surgery
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhard Prager, M.D.
Phone
+43-1-40400
Ext
5621
Email
gerhard.prager@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Felix B Langer, M.D.
Phone
+43-1-40400
Ext
5621
Email
felix.langer@meduniwien.ac.at
12. IPD Sharing Statement
Learn more about this trial
Banded Versus Non-banded Roux-en-Y Gastric Bypass
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