Laparoscopic Antireflux Surgery Versus Endoscopic Full-thickness Gastroplication for Gastroesophageal Reflux Disease (GERD)
Not Applicable
Completed
- Conditions
- Gastroesophageal Reflux Disease
- 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
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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the symptom improvement in GERD patients post Plicator-Procedure versus LARS?
How does laparoscopic antireflux surgery compare to endoscopic gastroplication in GERD treatment efficacy and safety profiles?
Are there specific biomarkers that predict better outcomes for Plicator-Procedure over laparoscopic fundoplication in GERD?
What are the long-term adverse event rates for endoscopic full-thickness gastroplication compared to traditional antireflux surgical interventions?
What combination therapies or alternative procedures are being evaluated alongside Plicator-Procedure for managing refractory GERD?
Trial Locations
- Locations (1)
GPH Zell am See
🇦🇹Zell am See, Salzburg, Austria
GPH Zell am See🇦🇹Zell am See, Salzburg, Austria