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OpenTrials
Completed

NCT Number: NCT01321294

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

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Laparoscopic Antireflux Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Public Hospital Zell am See

Zell am See, State of Salzburg, 5700, Austria

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic anti-reflux surgery

Procedure

Sponsors and collaborators

Lead sponsor

General Public Hospital Zell am See

Other

Registry information

Important dates

First posted
Mar 23, 2011
Registry last updated
Mar 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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