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

Primary Purpose

Gastroesophageal Reflux Disease

Status

Unknown status

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Full-Thickness-Gastroplication

About this trial

This is an interventional trial for Gastroesophageal Reflux Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

General public hospital Zell am SeeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Full-Thickness-Gastroplication

Arm Description

Outcomes

Primary Outcome Measures

Quality of Life

Secondary Outcome Measures

Full Information

NCT ID

NCT01453985

First Posted

October 12, 2011

Last Updated

October 14, 2011

Sponsor

General Public Hospital Zell am See

1. Study Identification

Unique Protocol Identification Number

NCT01453985

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Unknown status

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

General Public Hospital Zell am See

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux Disease

7. Study Design

Study Phase

Not Applicable

8. Arms, Groups, and Interventions

Arm Title

Full-Thickness-Gastroplication

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Full-Thickness-Gastroplication

Primary Outcome Measure Information:

Title

Quality of Life

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility 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: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rudolph Pointner, Prof.

Phone

004365427772210

ac.sekretariat@kh-zellamsee.at

Facility Information:

Facility Name

General public hospital Zell am See

City

Zell am See

ZIP/Postal Code

5700

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Oliver O Koch, MD

o.koch@sbg.at

First Name & Middle Initial & Last Name & Degree

Oliver O Koch, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

23021166

Citation

Koch OO, Kaindlstorfer A, Antoniou SA, Spaun G, Pointner R, Swanstrom LL. Subjective and objective data on esophageal manometry and impedance pH monitoring 1 year after endoscopic full-thickness plication for the treatment of GERD by using multiple plication implants. Gastrointest Endosc. 2013 Jan;77(1):7-14. doi: 10.1016/j.gie.2012.07.033. Epub 2012 Sep 26.

Results Reference

derived

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

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