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Full-Thickness-Gastroplication For The Treatment Of Gastroesophageal Reflux Disease GERD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01453985
Recruitment Status : Unknown
Verified October 2011 by General Public Hospital Zell am See.
Recruitment status was:  Recruiting
First Posted : October 18, 2011
Last Update Posted : October 18, 2011
Sponsor:
Information provided by (Responsible Party):
General Public Hospital Zell am See

Study Description
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Brief Summary:
This is a prospective study to extensively evaluate subjective patient parameters on quality of life, reflux-symptoms, side effects, medication-use and measurements of esophageal manometry and Impedance-pH-Monitoring after Full-Thickness-Gastroplication.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Procedure: Full-Thickness-Gastroplication Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
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Arm Intervention/treatment
Experimental: Full-Thickness-Gastroplication Procedure: Full-Thickness-Gastroplication


Outcome Measures
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Primary Outcome Measures :
  1. Quality of Life

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • persistent or recurrent symptoms despite continuous medical treatment, at least one typical reflux symptom (heartburn/ regurgitation/dysphagia/epigastric pain) and/or at least one atypical reflux symptom (cough/ asthma/hoarseness/distortion of taste), pathologic esophageal acid exposure as documented by a reflux-related DeMeester score ≥14.7, and symptom correlation ≥50%, and/or reflux episodes >73.

Exclusion Criteria:

  • any distinct hiatal hernia detectable by gastroscopy or barium radiography, dysphagia, esophageal strictures, poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453985


Contacts
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Contact: Rudolph Pointner, Prof. 004365427772210 ac.sekretariat@kh-zellamsee.at

Locations
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Austria
General public hospital Zell am See Recruiting
Zell am See, Austria, 5700
Contact: Oliver O Koch, MD       o.koch@sbg.at   
Sub-Investigator: Oliver O Koch, MD         
Sponsors and Collaborators
General Public Hospital Zell am See
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: General Public Hospital Zell am See
ClinicalTrials.gov Identifier: NCT01453985    
Other Study ID Numbers: Zell04
First Posted: October 18, 2011    Key Record Dates
Last Update Posted: October 18, 2011
Last Verified: October 2011
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases