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

June 23, 2010 updated by: Medical University of Vienna

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Excessive Weight Loss
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pouch dilatation, band migration, reflux, esophageal motility
Time Frame: 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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Gerhard Prager, M.D., Medical University of Vienna, Department of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

March 1, 2010

First Submitted That Met QC Criteria

March 1, 2010

First Posted (Estimate)

March 2, 2010

Study Record Updates

Last Update Posted (Estimate)

June 24, 2010

Last Update Submitted That Met QC Criteria

June 23, 2010

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUW ADIP STUDY 15
  • Banded Bypass Study 15 (Other Identifier: MUV - Metabolic and Bariatric Surgery)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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