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NCT01321294 Clinical Trial

Laparoscopic Nissen Versus Toupet Fundoplication: Objective and Subjective Results of a Prospective Randomized Trial

Gastroesophageal Reflux Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01321294
Other study ID # Zell01
Secondary ID
Status Completed
Phase N/A
First received March 21, 2011
Last updated March 22, 2011

Study information
Verified date March 2011
Source General Public Hospital Zell am See
Contact n/a
Is FDA regulated No
Health authority Austria: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare subjective and objective outcome and surgical "side effects" of Nissen and Toupet fundoplication performed in a single institution by only two surgeons and to compare pre and postoperative findings to healthy individuals.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of gastroesophageal reflux disease

- Long history of GERD symptoms

- Persistent or recurrent symptoms despite optimal medical treatment

- Persistent or recurrent complications of GERD

- Reduced quality of life owing to increasing esophageal exposure to gastric juice

- Pathological values in the preoperative evaluated functional parameters

Exclusion Criteria:

- Previous esophageal or gastric surgery

- Poor physical status (American Society of Anesthesiologists (ASA) scores III and IV)

- Pregnancy

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Procedure:
• laparoscopic anti-reflux surgery

Locations
Country Name City State
Austria General Public Hospital Zell am See Zell am See Salzburg

Sponsors (1)
Lead Sponsor Collaborator
General Public Hospital Zell am See

Country where clinical trial is conducted

Austria, 

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