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OpenTrials
Completed

NCT Number: NCT01324791

Laparoscopic Antireflux Surgery Versus Endoscopic Full-thickness Gastroplication for Gastroesophageal Reflux Disease (GERD)

Endoscopic full thickness gastroplication (Plicator-Procedure) has the potential to be a safe and effective alternative to laparoscopic antireflux surgery (LARS)to improve symptoms of GERD. This prospective randomized study compares objective and subjective outcome parameters of Plicator with that of LARS.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GPH 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

  • 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

  • any distinct hiatal hernia detectable by gastroscopy or barium radiography
  • dysphagia
  • esophageal strictures
  • poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.

Treatment and study plan

Anti-reflux surgery

Procedure

Sponsors and collaborators

Lead sponsor

General Public Hospital Zell am See

Other

Registry information

Important dates

First posted
Mar 29, 2011
Registry last updated
Mar 29, 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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