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

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)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01078181

Enrollment

100

Registered

2010-03-02

Start date

2009-11-30

Completion date

2014-05-31

Last updated

2010-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Keywords

gastric bypass, banded gastric bypass, weight loss, weight regain, bariatric surgery

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.

Interventions

PROCEDUREgastric bypass

laparoscopic gastric bypass with circular stapled 21mm gastrojejunostomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Excessive Weight Loss	3 years

Secondary

Measure	Time frame	Description
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

Countries

Austria

Contacts

Primary ContactGerhard Prager, M.D.

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

Backup ContactFelix B Langer, M.D.

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026