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Clinical Trials/NCT01453985
NCT01453985UnknownNot Applicable

Full-Thickness-Gastroplication For The Treatment Of Gastroesophageal Reflux Disease GERD

General Public Hospital Zell am See2 sites in 1 countryStarted: October 18, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Locations
2
Primary Endpoint
Quality of Life
Study OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is a prospective study to extensively evaluate subjective patient parameters on quality of life, reflux-symptoms, side effects, medication-use and measurements of esophageal manometry and Impedance-pH-Monitoring after Full-Thickness-Gastroplication.

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

  • •any distinct hiatal hernia detectable by gastroscopy or barium radiography, dysphagia, esophageal strictures, poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.

Outcomes

Primary Outcomes

Quality of Life

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
General Public Hospital Zell am See
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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