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

NCT ID: NCT01453985

Last Updated: 2011-10-18

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

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Gastroesophageal Reflux Disease

Study Groups

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Full-Thickness-Gastroplication

Group Type EXPERIMENTAL

Full-Thickness-Gastroplication

Intervention Type PROCEDURE

Interventions

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Full-Thickness-Gastroplication

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

* 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.
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

Responsible Party

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Responsibility Role SPONSOR

Locations

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General public hospital Zell am See

Zell am See, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Rudolph Pointner, Prof.

Role: CONTACT

[email protected]
004365427772210

Facility Contacts

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Oliver O Koch, MD

Role: primary

[email protected]

References

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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.

Reference Type DERIVED
PMID: 23021166 (View on PubMed)

Other Identifiers

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Zell04

Identifier Type: -

Identifier Source: org_study_id