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

NCT ID: NCT01078181

Last Updated: 2010-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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banded gastric bypass

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

Group Type ACTIVE_COMPARATOR

gastric bypass

Intervention Type PROCEDURE

laparoscopic gastric bypass with circular stapled 21mm gastrojejunostomy

non-banded gastric bypass

non-banded gastric bypass (circular anastomosis 21mm)

Group Type ACTIVE_COMPARATOR

gastric bypass

Intervention Type PROCEDURE

laparoscopic gastric bypass with circular stapled 21mm gastrojejunostomy

Interventions

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gastric bypass

laparoscopic gastric bypass with circular stapled 21mm gastrojejunostomy

Intervention Type PROCEDURE

Other Intervention Names

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laparoscopic gastric bypass laparoscopic banded gastric bypass

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Medical University of Vienna / Department of Surgery

Principal Investigators

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Gerhard Prager, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Department of Surgery

Locations

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Medical University of Vienna, Department of Surgery

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Gerhard Prager, M.D.

Role: CONTACT

+43-1-40400 ext. 5621

Felix B Langer, M.D.

Role: CONTACT

+43-1-40400 ext. 5621

Facility Contacts

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Gerhard Prager, M.D.

Role: primary

+43-1-40400 ext. 5621

Felix B Langer, M.D.

Role: backup

+43-1-40400 ext. 5621

Other Identifiers

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Banded Bypass Study 15

Identifier Type: OTHER

Identifier Source: secondary_id

MUW ADIP STUDY 15

Identifier Type: -

Identifier Source: org_study_id

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