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

Not Applicable

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Procedure: Full-Thickness-Gastroplication

• Registration Number: NCT01453985
• Lead Sponsor: General Public Hospital Zell am See

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-10
• Study First Submitted: 2011-10-12
• Study First Submitted QC: 2011-10-14
• Last Update Submitted: 2011-10-14
• Study First Posted: 2011-10-18
• Last Update Posted: 2011-10-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Full-Thickness-Gastroplication	Full-Thickness-Gastroplication	-

Primary Outcome Measures

Name	Time	Method
Quality of Life

Trial Locations

Locations (1)

General public hospital Zell am See; 🇦🇹 Zell am See, Austria