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NCT01324986 Clinical Trial

A Study on the Effectiveness of Laparoscopic Fundoplication on Extraesophageal Manifestations of Gastroesophageal Reflux Disease (GERD)

Gastroesophageal Reflux Disease (GERD) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01324986
Other study ID # Zell 03
Secondary ID
Status Completed
Phase N/A
First received March 27, 2011
Last updated April 8, 2011

Study information
Verified date March 2011
Source General Public Hospital Zell am See
Contact n/a
Is FDA regulated No
Health authority Austria: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Available data regarding the effectiveness of laparoscopic antireflux surgery on extraesophageal symptoms of gastroesophageal reflux disease (GERD) are scarce and mostly controversial. The aim of the present study was to evaluate the clinical effect of partial and total fundoplication on extraesophageal symptoms in a selected cohort of patients with GERD.

Recruitment information / eligibility
Status Completed
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:

- previous esophageal or gastric surgery, poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic anti-reflux surgery

Locations
Country Name City State
Austria General Public Hospital Zell am See Zell am See Salzburg

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

Country where clinical trial is conducted

Austria, 

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