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

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
anti-reflux surgery
Sponsored by
General Public Hospital Zell am See
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Gastroesophageal Reflux Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • GPH Zell am See

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

laparoscopic antireflux surgery

endoscopic full-thickness-gastroplication

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 26, 2011
Last Updated
March 28, 2011
Sponsor
General Public Hospital Zell am See
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1. Study Identification

Unique Protocol Identification Number
NCT01324791
Brief Title
Laparoscopic Antireflux Surgery Versus Endoscopic Full-thickness Gastroplication for Gastroesophageal Reflux Disease (GERD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
General Public Hospital Zell am See

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease

7. Study Design

Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Arm Title
laparoscopic antireflux surgery
Arm Type
Active Comparator
Arm Title
endoscopic full-thickness-gastroplication
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
anti-reflux surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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.
Facility Information:
Facility Name
GPH Zell am See
City
Zell am See
State/Province
Salzburg
ZIP/Postal Code
5700
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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