Trial record 1 of 137 for:    Open Studies | "gastric bypass"
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Banded Versus Non-banded Roux-en-Y Gastric Bypass

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Medical University of Vienna.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014