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

Sponsor
General Public Hospital Zell am See (Other)
Overall Status
Completed
CT.gov ID
NCT01321294
Collaborator
(none)
1
Location
2
Arms

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: laparoscopic anti-reflux surgery
 N/A

Study Design

Study Type:
Interventional

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Nissen fundoplication

Procedure: laparoscopic anti-reflux surgery
Active Comparator: Toupet fundoplication

Procedure: laparoscopic anti-reflux surgery

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 General Public Hospital Zell am See Zell am See Salzburg Austria 5700

    Sponsors and Collaborators

    • General Public Hospital Zell am See

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01321294
    Other Study ID Numbers:
    • Zell01
    First Posted:
    Mar 23, 2011
    Last Update Posted:
    Mar 23, 2011
    Last Verified:
    Mar 1, 2011
    Additional relevant MeSH terms:
    Gastroesophageal Reflux

    Study Results

    No Results Posted as of Mar 23, 2011