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

G

General Public Hospital Zell am See

Status

Completed

Conditions

Gastroesophageal Reflux Disease

Treatments

Procedure: anti-reflux surgery

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

0 participants in 2 patient groups

laparoscopic antireflux surgery
Active Comparator group
Treatment:
Procedure: anti-reflux surgery
endoscopic full-thickness-gastroplication
Active Comparator group
Treatment:
Procedure: anti-reflux surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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