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Esophageal Dysmotility and Dilatation After Laparoscopic Gastric Banding

Sponsor
Spital STS AG (Industry)
Overall Status
Completed
CT.gov ID
NCT01234428
Collaborator
Department of Medicine, Spital STS AG Thun (Other)
167
Enrollment
1
Location
1
Arm
141
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopic surgery
  • Procedure: gastric banding
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
167 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Esophageal Dysmotility Disorders Following Laparoscopic Gastric Banding - An Underestimated Complication.
Study Start Date :
Jun 1, 1998
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Mar 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Other: surgery

Procedure: Laparoscopic surgery
Gastric banding

Procedure: gastric banding
laparoscopic gastric banding
Other Names:
  • morbid obesity

    		•

    Outcome Measures

    Primary Outcome Measures

    1. esophageal dilatation [yearly follow-up over 12 year period]

      esophageal dilatation or dysfunction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • BMI more than 40
    Exclusion Criteria:
    • BMI below 40

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01234428
    Other Study ID Numbers:
    • MOB-12-STS-AG
    First Posted:
    Nov 4, 2010
    Last Update Posted:
    Nov 4, 2010
    Last Verified:
    Nov 1, 2010
    Keywords provided by , ,
    laparoscopy
    adjustable gastric banding
    morbid obesity
    esophageal motility
    esophageal dilatation
    Additional relevant MeSH terms:
    Esophageal Motility Disorders
    Esophageal Spasm, Diffuse

    Study Results

    No Results Posted as of Nov 4, 2010