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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. 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
Information provided by (Responsible Party):
General Public Hospital Zell am See

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

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Study Type : Interventional  (Clinical Trial)

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: Full-Thickness-Gastroplication Procedure: Full-Thickness-Gastroplication

Primary Outcome Measures :
  1. Quality of Life

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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.

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 identifier (NCT number): NCT01453985

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Contact: Rudolph Pointner, Prof. 004365427772210

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General public hospital Zell am See Recruiting
Zell am See, Austria, 5700
Contact: Oliver O Koch, MD   
Sub-Investigator: Oliver O Koch, MD         
Sponsors and Collaborators
General Public Hospital Zell am See
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: General Public Hospital Zell am See 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
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases