Reversibility of Dysmotility After Gastric Banding - Full Text View

Sponsors and Collaborators:	Cantonal Hospital of St. Gallen University of Zurich
Information provided by:	Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:	NCT00680030

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

MedlinePlus related topics: Esophagus Disorders

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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)

Groups/Cohorts
1

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

Keywords provided by Cantonal Hospital of St. Gallen:

impedance
manometry
motility disorders

ineffective motility
diffuse esophageal spasms
achlasia-like dysmotility

Study placed in the following topic categories:

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

Gastrointestinal Diseases
Esophageal Achalasia
Esophageal Diseases
Cardiospasm
Achalasia

Additional relevant MeSH terms:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases

Esophageal Spasm, Diffuse
Gastrointestinal Diseases
Esophageal Diseases

ClinicalTrials.gov processed this record on May 07, 2009