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NCT01453985 Clinical Trial

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

Gastroesophageal Reflux Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01453985
Other study ID # Zell04
Secondary ID
Status Recruiting
Phase N/A
First received October 12, 2011
Last updated October 14, 2011

Study information
Verified date October 2011
Source General Public Hospital Zell am See
Contact Rudolph Pointner, Prof.
Phone 004365427772210
Email ac.sekretariat@kh-zellamsee.at
Is FDA regulated No
Health authority Austria: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Procedure:
• Full-Thickness-Gastroplication

Locations
Country Name City State
Austria General public hospital Zell am See Zell am See

Sponsors (1)
Lead Sponsor Collaborator
General Public Hospital Zell am See

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of Life
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