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Clinical Trials/NCT01324986
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

Sponsor
General Public Hospital Zell am See
Sponsor Class
Other

Study Sites (2)

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