NCT01078181

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 24, 2010

Status Verified

November 1, 2009

Enrollment Period

4.5 years

First QC Date

March 1, 2010

Last Update Submit

June 23, 2010

Conditions

Morbid Obesity

Keywords

gastric bypassbanded gastric bypassweight lossweight regainbariatric surgery

Outcome Measures

Primary Outcomes (1)

  • Excessive Weight Loss

    3 years

Secondary Outcomes (1)

  • pouch dilatation, band migration, reflux, esophageal motility

    3 years

Study Arms (2)

banded gastric bypass

ACTIVE COMPARATOR

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

Procedure: gastric bypass

non-banded gastric bypass

ACTIVE COMPARATOR

non-banded gastric bypass (circular anastomosis 21mm)

Procedure: gastric bypass

Interventions

gastric bypassPROCEDURE

laparoscopic gastric bypass with circular stapled 21mm gastrojejunostomy

Also known as: laparoscopic gastric bypass, laparoscopic banded gastric bypass
banded gastric bypassnon-banded gastric bypass

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \> 40 or BMI \> 35 + hypertension/diabetes mellitus
  • pH metry and manometry preoperatively

You may not qualify if:

  • formerly operations of the stomach
  • formerly open abdominal surgery
  • malignancy within the last 5 years
  • formerly gastric banding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Surgery

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Obesity, MorbidWeight Loss

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Gerhard Prager, M.D.

    Medical University of Vienna, Department of Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerhard Prager, M.D.

CONTACT

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

Felix B Langer, M.D.

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2010

First Posted

March 2, 2010

Study Start

November 1, 2009

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 24, 2010

Record last verified: 2009-11

Locations

AU(1)