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

Tracking Information
First Received Date ^ICMJE	March 21, 2011
Last Updated Date	March 22, 2011
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01321294 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Laparoscopic Nissen Versus Toupet Fundoplication: Objective and Subjective Results of a Prospective Randomized Trial
Official Title ^ICMJE	Not Provided
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Gastroesophageal Reflux Disease Laparoscopic Antireflux Surgery
Intervention ^ICMJE	Procedure: laparoscopic anti-reflux surgery
Study Arm (s)	Active Comparator: Nissen fundoplication Intervention: Procedure: laparoscopic anti-reflux surgery Active Comparator: Toupet fundoplication Intervention: Procedure: laparoscopic anti-reflux surgery
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Austria

Administrative Information
NCT Number ^ICMJE	NCT01321294
Other Study ID Numbers ^ICMJE	Zell01
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	General Public Hospital Zell am See
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	General Public Hospital Zell am See
Verification Date	March 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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