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

Medical University of Vienna

Status: Unknown

Conditions: Morbid Obesity

Treatments: Procedure: gastric bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT01078181

MUW ADIP STUDY 15

Banded Bypass Study 15 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

banded gastric bypass

Active Comparator group

Description:

Banded gastric bypass (circular anastomosis 21mm) using the A.M.I. B-Band (Soft Gastric Bypass Band)

Treatment:

Procedure: gastric bypass

non-banded gastric bypass

Active Comparator group

Description:

non-banded gastric bypass (circular anastomosis 21mm)

Treatment:

Procedure: gastric bypass