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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01324986
First Posted: March 29, 2011
Last Update Posted: April 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
General Public Hospital Zell am See
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT01324986     History of Changes
Other Study ID Numbers: Zell 03
First Submitted: March 27, 2011
First Posted: March 29, 2011
Last Update Posted: April 11, 2011
Last Verified: March 2011

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