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

G

General Public Hospital Zell am See

Status

Completed

Conditions

Gastroesophageal Reflux Disease (GERD)
Extraesophageal Symptoms

Treatments

Procedure: Laparoscopic anti-reflux surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT01324986
Zell 03

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

0 participants in 2 patient groups

Nissen fundoplication
Active Comparator group
Treatment:
Procedure: Laparoscopic anti-reflux surgery
Toupet fundoplication
Active Comparator group
Treatment:
Procedure: Laparoscopic anti-reflux surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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