A randomized controlled trial of laparoscopic Nissen fundoplication versus proton pump inhibitors for the treatment of patients with chronic gastroesophageal reflux disease (GERD): 3-year outcomes.

McMaster University (Canada)0 个研究点目标入组 216 人开始时间: 2005年9月1日最近更新: 2019年2月11日

适应症

试验速览

2011 results in https://www.ncbi.nlm.nih.gov/pubmed/21512887 (added 31/01/2019) 2. 2011 economic evaluation results in https://www.ncbi.nlm.nih.gov/pubmed/21402295 (added 31/01/2019)

•1. Male or female GERD patients aged 18 - 70 years with GERD symptoms
•2. Prior long-term treatment with Proton Pump Inhibitors (PPI) with minimum duration of 1 year with expected future duration of at least 2 more years
•3. Controlled on 20 - 40 mg/day maintenance PPI therapy prior to study, defined as GERD symptom score less than 25 and score of 70 or more on 1 - 100 Global Rating Scale at screening
•4. Increase in GERD symptom score greater than or equal to 15 points at baseline (off omeprazole)
•5. GERD symptom score greater than or equal to 25 at baseline (off omeprazole)
•6. Percent acid reflux in 24 hour 24% at baseline off omeprazole
•7. Positive Bernstein test at baseline
•8. Willingness to adhere to randomised treatment with availability for 3 years of follow-up
•9. Ability to answer self and interviewer-administered questions in English
•10. Signed informed consent

•1. Aperistaltic oesophagus
•2. Severe cardiac, respiratory, haematologic or other disease constituting an unacceptable surgical risk in the investigator?s opinion
•3. Previous gastric, oesophageal or anti-reflux surgery
•4. History of malignancy within the last year with the exception of basal cell carcinoma
•5. Pregnancy or an intention to become pregnant in the following year

发起方

McMaster University (Canada)