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

This study has been completed.
Sponsor:
Information provided by:
General Public Hospital Zell am See
ClinicalTrials.gov Identifier:
NCT01324986
First received: March 27, 2011
Last updated: April 8, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Extraesophageal Symptoms
Gastroesophageal Reflux Disease (GERD)
Procedure: Laparoscopic anti-reflux surgery

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by General Public Hospital Zell am See:

Arms Assigned Interventions
Active Comparator: Nissen fundoplication Procedure: Laparoscopic anti-reflux surgery
Active Comparator: Toupet fundoplication Procedure: Laparoscopic anti-reflux surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01324986

Locations
Austria
General Public Hospital Zell am See
Zell am See, Salzburg, Austria, 5700
Sponsors and Collaborators
General Public Hospital Zell am See
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01324986     History of Changes
Other Study ID Numbers: Zell 03
Study First Received: March 27, 2011
Last Updated: April 8, 2011
Health Authority: Austria: Institutional Review Board

Keywords provided by General Public Hospital Zell am See:
extraesophageal symptoms of gastroesophageal reflux disease

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 21, 2014