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

This study has been completed.
Sponsor:
Information provided by:
General Public Hospital Zell am See
ClinicalTrials.gov Identifier:
NCT01321294
First received: March 21, 2011
Last updated: March 22, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Gastroesophageal Reflux Disease
Laparoscopic Antireflux Surgery
 Procedure: laparoscopic anti-reflux surgery

Study Type: Interventional

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by General Public Hospital Zell am See:

Arms Assigned Interventions
Active Comparator: Nissen fundoplication Procedure: laparoscopic anti-reflux surgery
Active Comparator: Toupet fundoplication Procedure: laparoscopic anti-reflux surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321294

Locations
Austria
General Public Hospital Zell am See
Zell am See, Salzburg, Austria, 5700
Sponsors and Collaborators
General Public Hospital Zell am See
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01321294     History of Changes
Other Study ID Numbers: Zell01
Study First Received: March 21, 2011
Last Updated: March 22, 2011
Health Authority: Austria: Institutional Review Board

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013