NCT01324986CompletedNot Applicable
A Study on the Effectiveness of Laparoscopic Fundoplication on Extraesophageal Manifestations of Gastroesophageal Reflux Disease (GERD)
General Public Hospital Zell am See2 sites in 1 countryStarted: March 29, 2011Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Locations
- 2
Study Overview
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.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Nissen fundoplication
Active Comparator
Intervention: Laparoscopic anti-reflux surgery (Procedure)
Toupet fundoplication
Active Comparator
Intervention: Laparoscopic anti-reflux surgery (Procedure)
Investigators
Study Sites (2)
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