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

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Procedure: anti-reflux surgery

• Registration Number: NCT01324791
• Lead Sponsor: General Public Hospital Zell am See

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-03
• Study First Submitted: 2011-03-26
• Study First Submitted QC: 2011-03-28
• Last Update Submitted: 2011-03-28
• Study First Posted: 2011-03-29
• Last Update Posted: 2011-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
laparoscopic antireflux surgery	anti-reflux surgery	-
endoscopic full-thickness-gastroplication	anti-reflux surgery	-

Trial Locations

Locations (1)

GPH Zell am See; 🇦🇹 Zell am See, Salzburg, Austria