Back to resultsA Study on the Effectiveness of Laparoscopic Fundoplication on Extraesophageal Manifestations of Gastroesophageal Reflux Disease (GERD)
Primary Purpose
Extraesophageal Symptoms, Gastroesophageal Reflux Disease (GERD)
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Laparoscopic anti-reflux surgery
Sponsored by
About this trial
This is an interventional trial for Extraesophageal Symptoms focused on measuring extraesophageal symptoms of gastroesophageal reflux disease
Eligibility 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:
- previous esophageal or gastric surgery, poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.
Sites / Locations
- General Public Hospital Zell am See
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Nissen fundoplication
Toupet fundoplication
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01324986
First Posted
March 27, 2011
Last Updated
April 8, 2011
Sponsor
General Public Hospital Zell am See
1. Study Identification
Unique Protocol Identification Number
NCT01324986
Brief Title
A Study on the Effectiveness of Laparoscopic Fundoplication on Extraesophageal Manifestations of Gastroesophageal Reflux Disease (GERD)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
General Public Hospital Zell am See
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extraesophageal Symptoms, Gastroesophageal Reflux Disease (GERD)
Keywords
extraesophageal symptoms of gastroesophageal reflux disease
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
Nissen fundoplication
Arm Type
Active Comparator
Arm Title
Toupet fundoplication
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic anti-reflux surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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:
previous esophageal or gastric surgery, poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.
Facility Information:
Facility Name
General Public Hospital Zell am See
City
Zell am See
State/Province
Salzburg
ZIP/Postal Code
5700
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
A Study on the Effectiveness of Laparoscopic Fundoplication on Extraesophageal Manifestations of Gastroesophageal Reflux Disease (GERD)
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