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

NCT ID: NCT01324986

Last Updated: 2011-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Extraesophageal Symptoms Gastroesophageal Reflux Disease (GERD)

Study Groups

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Nissen fundoplication

Group Type ACTIVE_COMPARATOR

Laparoscopic anti-reflux surgery

Intervention Type PROCEDURE

Toupet fundoplication

Group Type ACTIVE_COMPARATOR

Laparoscopic anti-reflux surgery

Intervention Type PROCEDURE

Interventions

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Laparoscopic anti-reflux surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Public Hospital Zell am See

OTHER

Sponsor Role lead

Locations

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General Public Hospital Zell am See

Zell am See, Salzburg, Austria

Site Status

Countries

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Austria

Other Identifiers

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Zell 03

Identifier Type: -

Identifier Source: org_study_id

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