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NCT01324791 Clinical Trial

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

Gastroesophageal Reflux Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01324791
Other study ID # Zell02
Secondary ID
Status Completed
Phase N/A
First received March 26, 2011
Last updated March 28, 2011

Study information
Verified date March 2011
Source General Public Hospital Zell am See
Contact n/a
Is FDA regulated No
Health authority Austria: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

N/A

Related Conditions & MeSH terms

Intervention

Procedure:
• anti-reflux surgery

Locations
Country Name City State
Austria GPH Zell am See Zell am See Salzburg

Sponsors (1)
Lead Sponsor Collaborator
General Public Hospital Zell am See

Country where clinical trial is conducted

Austria, 

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