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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01321294
First Posted: March 23, 2011
Last Update Posted: March 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
General Public Hospital Zell am See
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01321294     History of Changes
Other Study ID Numbers: Zell01
First Submitted: March 21, 2011
First Posted: March 23, 2011
Last Update Posted: March 23, 2011
Last Verified: March 2011

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