Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 21, 2011
March 22, 2011
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT01321294 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Laparoscopic Nissen Versus Toupet Fundoplication: Objective and Subjective Results of a Prospective Randomized Trial
Not Provided

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.

Not Provided
Interventional
Not Provided
Not Provided
  • Gastroesophageal Reflux Disease
  • Laparoscopic Antireflux Surgery
Procedure: laparoscopic anti-reflux surgery
  • Active Comparator: Nissen fundoplication
    Intervention: Procedure: laparoscopic anti-reflux surgery
  • Active Comparator: Toupet fundoplication
    Intervention: Procedure: laparoscopic anti-reflux surgery
Koch OO, Kaindlstorfer A, Antoniou SA, Luketina RR, Emmanuel K, Pointner R. Comparison of results from a randomized trial 1 year after laparoscopic Nissen and Toupet fundoplications. Surg Endosc. 2013 Jul;27(7):2383-90. doi: 10.1007/s00464-013-2803-0. Epub 2013 Jan 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01321294
Zell01
Not Provided
Not Provided
General Public Hospital Zell am See
Not Provided
Not Provided
General Public Hospital Zell am See
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP