Esophageal Dysmotility and Dilatation After Laparoscopic Gastric Banding

November 2, 2010 updated by: Spital STS AG

Esophageal Dysmotility Disorders Following Laparoscopic Gastric Banding - An Underestimated Complication.

The purpose of this study is to determine whether esophageal dysmotility and dilatation is an important complication in the long term follow-up following laparoscopic gastric banding for morbid obesity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Using a yearly barium swallow the diameter of the esophagus will be monitored over the period.

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Thun, Switzerland, 3600
        • Department of Surgery, Spital STS AG Thun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI more than 40

Exclusion Criteria:

  • BMI below 40

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: surgery
Procedure: Laparoscopic surgery
Gastric banding
Procedure: gastric banding
laparoscopic gastric banding
Other Names:
  • morbid obesity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
esophageal dilatation
Time Frame: yearly follow-up over 12 year period
esophageal dilatation or dysfunction
yearly follow-up over 12 year period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spital STS AG

Collaborators

Department of Medicine, Spital STS AG Thun

Investigators

  • Principal Investigator: Markus Naef, MD, MBA, Spital STS AG Thun, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1998

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

November 2, 2010

First Submitted That Met QC Criteria

November 2, 2010

First Posted (ESTIMATE)

November 4, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 4, 2010

Last Update Submitted That Met QC Criteria

November 2, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOB-12-STS-AG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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