NCT01453985

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2011

Completed
Last Updated

October 18, 2011

Status Verified

October 1, 2011

First QC Date

October 12, 2011

Last Update Submit

October 14, 2011

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

Study Arms (1)

Full-Thickness-Gastroplication

EXPERIMENTAL
Procedure: Full-Thickness-Gastroplication

Interventions

Full-Thickness-GastroplicationPROCEDURE
Full-Thickness-Gastroplication

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General public hospital Zell am See

Zell am See, 5700, Austria

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23021166DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Rudolph Pointner, Prof.

CONTACT

004365427772210ac.sekretariat@kh-zellamsee.at

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2011

First Posted

October 18, 2011

Last Updated

October 18, 2011

Record last verified: 2011-10

Locations

AU(1)