NCT01324986

Brief Summary

Available data regarding the effectiveness of laparoscopic antireflux surgery on extraesophageal symptoms of gastroesophageal reflux disease (GERD) are scarce and mostly controversial. The aim of the present study was to evaluate the clinical effect of partial and total fundoplication on extraesophageal symptoms in a selected cohort of patients with GERD.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

March 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
Last Updated

April 11, 2011

Status Verified

March 1, 2011

First QC Date

March 27, 2011

Last Update Submit

April 8, 2011

Conditions

Extraesophageal SymptomsGastroesophageal Reflux Disease (GERD)

Keywords

extraesophageal symptoms of gastroesophageal reflux disease

Study Arms (2)

Nissen fundoplication

ACTIVE COMPARATOR
Procedure: Laparoscopic anti-reflux surgery

Toupet fundoplication

ACTIVE COMPARATOR
Procedure: Laparoscopic anti-reflux surgery

Interventions

Laparoscopic anti-reflux surgeryPROCEDURE
Nissen fundoplicationToupet fundoplication

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:

  • previous esophageal or gastric surgery, 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, Salzburg, 5700, Austria

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2011

First Posted

March 29, 2011

Last Updated

April 11, 2011

Record last verified: 2011-03

Locations

AU(1)