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

Medical University of Vienna100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Morbid Obesity

Interventions

gastric bypassPROCEDURE

laparoscopic gastric bypass with circular stapled 21mm gastrojejunostomy

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of Vienna, Department of Surgery

Vienna, Austria

RECRUITING

Outcomes

Primary Outcomes

Excessive Weight Loss

Time frame: 3 years

Secondary Outcomes

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

Time frame: 3 years

Central Contacts

Gerhard Prager, M.D.

CONTACT

+43-1-40400 gerhard.prager@meduniwien.ac.at

Felix B Langer, M.D.

CONTACT

+43-1-40400 felix.langer@meduniwien.ac.at

Data from ClinicalTrials.gov

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