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NCT01234428 Clinical Trial

Esophageal Dysmotility and Dilatation After Laparoscopic Gastric Banding

Esophageal Motility Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01234428
Other study ID # MOB-12-STS-AG
Secondary ID
Status Completed
Phase N/A
First received November 2, 2010
Last updated November 2, 2010
Start date June 1998
Est. completion date March 2010

Study information
Verified date November 2010
Source Spital STS AG
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swiss Morbid Obesity Study Group
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 167
Est. completion date March 2010
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- BMI more than 40

Exclusion Criteria:

- BMI below 40

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic surgery
Gastric banding
• gastric banding
laparoscopic gastric banding

Locations
Country Name City State
Switzerland Department of Surgery, Spital STS AG Thun Thun

Sponsors (2)
Lead Sponsor Collaborator
Spital STS AG Department of Medicine, Spital STS AG Thun

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary esophageal dilatation esophageal dilatation or dysfunction yearly follow-up over 12 year period No
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