Clinical trial: Treatment Of Gastroesophageal Reflux Disease By Endoscopic Fundoplication, A Placebo-Controlled Study (NCT00235677)

Eligibility criteria:
Inclusion Criteria:

          -  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 Criteria:

          -  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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? 0