Back to resultsLaparoscopic Nissen Versus Toupet Fundoplication: Objective and Subjective Results of a Prospective Randomized Trial
Primary Purpose
Gastroesophageal Reflux Disease, Laparoscopic Antireflux Surgery
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
laparoscopic anti-reflux surgery
Sponsored by
About this trial
This is an interventional trial for Gastroesophageal Reflux Disease
Eligibility 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
Sites / Locations
- General Public Hospital Zell am See
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Nissen fundoplication
Toupet fundoplication
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01321294
First Posted
March 21, 2011
Last Updated
March 22, 2011
Sponsor
General Public Hospital Zell am See
1. Study Identification
Unique Protocol Identification Number
NCT01321294
Brief Title
Laparoscopic Nissen Versus Toupet Fundoplication: Objective and Subjective Results of a Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
General Public Hospital Zell am See
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Laparoscopic Antireflux Surgery
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
Nissen fundoplication
Arm Type
Active Comparator
Arm Title
Toupet fundoplication
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
laparoscopic anti-reflux surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Facility Information:
Facility Name
General Public Hospital Zell am See
City
Zell am See
State/Province
Salzburg
ZIP/Postal Code
5700
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
23361260
Citation
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.
Results Reference
derived
Learn more about this trial
Laparoscopic Nissen Versus Toupet Fundoplication: Objective and Subjective Results of a Prospective Randomized Trial
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