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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Motility Disorders
Esophageal Spasm, Diffuse
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 22, 2014