Status:
COMPLETED
Treatment Of Gastroesophageal Reflux Disease By Endoscopic Fundoplication, A Placebo-Controlled Study
Lead Sponsor:
UMC Utrecht
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Aim: To evaluate the therapeutic efficacy of a therapeutic procedure, involving endoscopic suturing, for gastroesophageal reflux disease (GERD) compared to a sham procedure. The hypotheses tested in...
Detailed Description
Gastroesophageal reflux disease (GERD) and the chronic, often lifelong, use of antisecretory medication have great clinical and economical implications for the patient, practicing physician and societ...
Eligibility Criteria
Inclusion
- typical symptoms of GERD (i.e., heartburn, regurgitation) for \> 6 months,
- pathological esophageal acid exposure after discontinuation of medical therapy, proven by ambulatory 24-hour pH-monitoring with \> 5% of time a pH \< 4 and a symptom-association probability \> 95% (19)
- patients considered for non-medical therapy, i.e. unwillingness to take life-long medication in medically-responding disease, suffering from medication side-effects or medically-intractable disease and unwillingness to undergo surgery
- willingness to accept a pre-treatment observation period of three months duration
- written informed consent
Exclusion
- severe preexisting esophageal motility disorder (i.e., more than \>40% non-transmitted or simultaneous contractions during a short esophageal manometry study)
- hiatal hernia (\> 3 cm in length)
- history of antireflux or esophageal/gastric surgery
- severe psychiatric disease
- reflux esophagitis grade D (LA classification)
- Barrett's esophagus with dysplasia
- esophageal stenosis/malignancy
- pregnancy or lactation
- history of low therapeutic compliance
- other severe comorbidity (including cardiopulmonary disease, portal hypertension, collagen diseases, morbid obesity, coagulation disorder)
- use of anticoagulant or immunosuppressive drugs
- history of alcohol or drug abuse
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00235677
Start Date
August 1 2003
End Date
August 1 2005
Last Update
October 10 2005
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dept. of Gastroenterology, UMC Utrecht
Utrecht, Netherlands, 3584 CX