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

NCT ID: NCT01324791

Last Updated: 2011-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastroesophageal Reflux Disease

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

laparoscopic antireflux surgery

Group Type ACTIVE_COMPARATOR

anti-reflux surgery

Intervention Type PROCEDURE

endoscopic full-thickness-gastroplication

Group Type ACTIVE_COMPARATOR

anti-reflux surgery

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

anti-reflux surgery

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

General Public Hospital Zell am See

OTHER

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GPH Zell am See

Zell am See, Salzburg, Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Zell02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

LINX vs Fundoplication
NCT07093359 RECRUITING PHASE3