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Esophageal Dysmotility and Dilatation After Laparoscopic Gastric Banding

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01234428
First Posted: November 4, 2010
Last Update Posted: November 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Department of Medicine, Spital STS AG Thun
Information provided by:
Spital STS AG
  Purpose
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.

Condition Intervention
Esophageal Motility Disorders Procedure: Laparoscopic surgery Procedure: gastric banding

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Esophageal Dysmotility Disorders Following Laparoscopic Gastric Banding - An Underestimated Complication.

Further study details as provided by Spital STS AG:

Primary Outcome Measures:
  • esophageal dilatation [ Time Frame: yearly follow-up over 12 year period ]
    esophageal dilatation or dysfunction


Enrollment: 167
Study Start Date: June 1998
Study Completion Date: March 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
surgery Procedure: Laparoscopic surgery
Gastric banding
Procedure: gastric banding
laparoscopic gastric banding
Other Name: morbid obesity

Detailed Description:
Using a yearly barium swallow the diameter of the esophagus will be monitored over the period.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI more than 40

Exclusion Criteria:

  • BMI below 40
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234428


Locations
Switzerland
Department of Surgery, Spital STS AG Thun
Thun, Switzerland, 3600
Sponsors and Collaborators
Spital STS AG
Department of Medicine, Spital STS AG Thun
Investigators
Principal Investigator: Markus Naef, MD, MBA Spital STS AG Thun, Switzerland
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Markus Naef, MD, MBA, Department of Surgery, Spital STS AG Thun, Switzerland
ClinicalTrials.gov Identifier: NCT01234428     History of Changes
Other Study ID Numbers: MOB-12-STS-AG
First Submitted: November 2, 2010
First Posted: November 4, 2010
Last Update Posted: November 4, 2010
Last Verified: November 2010

Keywords provided by Spital STS AG:
laparoscopy
adjustable gastric banding
morbid obesity
esophageal motility
esophageal dilatation

Additional relevant MeSH terms:
Esophageal Motility Disorders
Esophageal Spasm, Diffuse
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases