Back to resultsEsophageal Dysmotility and Dilatation After Laparoscopic Gastric Banding
Primary Purpose
Esophageal Motility Disorders
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Laparoscopic surgery
gastric banding
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Motility Disorders focused on measuring laparoscopy, adjustable gastric banding, morbid obesity, esophageal motility, esophageal dilatation
Eligibility Criteria
Inclusion Criteria:
- BMI more than 40
Exclusion Criteria:
- BMI below 40
Sites / Locations
- Department of Surgery, Spital STS AG Thun
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
surgery
Arm Description
Outcomes
Primary Outcome Measures
esophageal dilatation
esophageal dilatation or dysfunction
Secondary Outcome Measures
Full Information
NCT ID
NCT01234428
First Posted
November 2, 2010
Last Updated
November 2, 2010
Sponsor
Spital STS AG
Collaborators
Department of Medicine, Spital STS AG Thun
1. Study Identification
Unique Protocol Identification Number
NCT01234428
Brief Title
Esophageal Dysmotility and Dilatation After Laparoscopic Gastric Banding
Official Title
Esophageal Dysmotility Disorders Following Laparoscopic Gastric Banding - An Underestimated Complication.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Spital STS AG
Collaborators
Department of Medicine, Spital STS AG Thun
4. Oversight
Data Monitoring Committee
No
5. 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.
Detailed Description
Using a yearly barium swallow the diameter of the esophagus will be monitored over the period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Motility Disorders
Keywords
laparoscopy, adjustable gastric banding, morbid obesity, esophageal motility, esophageal dilatation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
surgery
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic surgery
Intervention Description
Gastric banding
Intervention Type
Procedure
Intervention Name(s)
gastric banding
Other Intervention Name(s)
morbid obesity
Intervention Description
laparoscopic gastric banding
Primary Outcome Measure Information:
Title
esophageal dilatation
Description
esophageal dilatation or dysfunction
Time Frame
yearly follow-up over 12 year period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI more than 40
Exclusion Criteria:
BMI below 40
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Naef, MD, MBA
Organizational Affiliation
Spital STS AG Thun, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Spital STS AG Thun
City
Thun
ZIP/Postal Code
3600
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21169806
Citation
Naef M, Mouton WG, Naef U, van der Weg B, Maddern GJ, Wagner HE. Esophageal dysmotility disorders after laparoscopic gastric banding--an underestimated complication. Ann Surg. 2011 Feb;253(2):285-90. doi: 10.1097/SLA.0b013e318206843e.
Results Reference
derived
Learn more about this trial
Esophageal Dysmotility and Dilatation After Laparoscopic Gastric Banding
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