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Esophageal Dysmotility and Dilatation After Laparoscopic Gastric Banding

This study has been completed.
Sponsor:
Collaborator:
Department of Medicine, Spital STS AG Thun
Information provided by:
Spital STS AG
ClinicalTrials.gov Identifier:
NCT01234428
First received: November 2, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Esophageal Dysmotility Disorders Following Laparoscopic Gastric Banding - An Underestimated Complication.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Spital STS AG:

Primary Outcome Measures:
  • esophageal dilatation [ Time Frame: yearly follow-up over 12 year period ] [ Designated as safety issue: No ]
    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
Other Name: laparoscopic surgery
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI more than 40

Exclusion Criteria:

  • BMI below 40
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Spital STS AG

Additional 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
Study First Received: November 2, 2010
Last Updated: November 2, 2010
Health Authority: Switzerland: Swiss Morbid Obesity Study Group

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

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

ClinicalTrials.gov processed this record on May 19, 2013