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Reversibility of Dysmotility After Gastric Banding

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of Zurich
Information provided by:
Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT00680030
First received: May 15, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

In the current study we plan to evaluate the effects of the conversion from gastric banding to gastric bypass on esophageal function using combined monitoring. The primary aim of the current study is to evaluate esophageal function before and 3-months after the conversion from gastric banding to gastric bypass. A second objective is to evaluate the severity of symptoms, esophageal dysmotilities, endoscopic abnormalities and bolus retention found in patients referred for conversion from gastric banding to gastric bypass. Our hypothesis is that esophageal motility disorders associated with gastric banding are reversed by conversion to gastric bypass.


Condition
Ineffective Motility
Diffuse Esophageal Spasms
Achalasia-Like Dysmotility

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Reversibility of Esophageal Dysmotilities Associated With Gastric Banding After Conversion to Gastric Bypass

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • reversibility of dysmotility after surgery [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • degree of dysmoztility after gastric banding [ Time Frame: not defined ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: September 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Morbidly obese patients in whom a conversion from gastric band to gastric bypass is planed

Criteria

Inclusion Criteria:

  • Patients in whom a conversion from gastric band to gastric bypass is planed

Exclusion Criteria:

  • Acute cardiac or pulmonary conditions
  • Antireflux surgery or antireflux endoscopic procedures.
  • Patients unable to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680030

Locations
Switzerland
Cantonal Hospital St. Gallen
St. Gallen, Switzerland
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
University of Zurich
Investigators
Study Chair: Patrizia Kuenzler, study nurse Cantonal Hospital St. Gallen
  More Information

No publications provided

Responsible Party: PD Dr. med. Jan Borovicka, MD, Divison of Gastroenterology, Cantonal Hospital St. Gallen
ClinicalTrials.gov Identifier: NCT00680030     History of Changes
Other Study ID Numbers: EKSG 06/91
Study First Received: May 15, 2008
Last Updated: May 15, 2008
Health Authority: Switzerland: Ethikkommission

Keywords provided by Cantonal Hospital of St. Gallen:
impedance
manometry
motility disorders
 ineffective motility
diffuse esophageal spasms
achlasia-like dysmotility

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Diseases
Esophageal Motility Disorders
Esophageal Spasm, Diffuse
Spasm
Deglutition Disorders
 Gastrointestinal Diseases
Digestive System Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013