Kalpesh Jani, MD
In patients with chronic gastroesophageal reflux disease (GERD), is a strategy of early laparoscopic surgery more effective and cost-effective than a strategy of continued medical management?
Randomized controlled trial and economic analysis. Current Controlled Trials ISRCTN 15517081.
12 months after surgery or an equivalent time in patients who did not have surgery.
21 hospitals in the UK.
357 patients ≥ 18 years of age (mean age 46 y, 66% men) who had documented evidence of GERD and symptoms for >12 months and for whom the best management policy was uncertain. Exclusion criteria included body mass index > 40 kg/m2, Barrett esophagus > 3 cm, evidence of dysplasia, paraesophageal hernia, and esophageal stricture.
A strategy of laparoscopic fundoplication (technique selected by surgeon) (n = 178) or a strategy of best medical management with proton pump inhibitors (PPIs) or histamine-receptor antagonists (n = 179).
Primary outcome was REFLUX quality-of-life score. Secondary outcomes included 5 REFLUX symptoms scores, quality-adjusted life-years (QALYs, based on EuroQol-5 Dimensions instrument), and health care costs.
89% (intention-to-treat analysis).
62% of patients in the surgical group and 6% in the medical group received surgery. At 12 months, 38% and 90%, respectively, were taking reflux-related drugs. The Table shows the REFLUX questionnaire results. At 1 year, the mean per-patient cost of treatment was £1786 in the surgical group and £506 in the medical group (difference £1280, 95% CI 1054 to 1468). Surgical treatment achieved an increase of 0.066 (CI 0.026 to 0.107) QALYs compared with medical treatment. The incremental cost-effectiveness ratio was £19 288/QALY.
In patients with chronic gastroesophageal reflux disease, a strategy of early laparoscopic surgery improved quality of life and reduced symptoms more than a strategy of continued medical management at least up to 1 year after surgery; however, the cost-effectiveness of surgical treatment at 1 year is uncertain.
Surgical management vs medical management for chronic gastroesophageal reflux disease
†Quality-of-life and 5 symptom scores derived from the 31-item REFLUX questionnaire developed for the trial; range of scores 0 to 100 (best).
‡CI defined in Glossary. Differences adjusted for age, sex, body mass index, baseline score, and baseline × group interaction; a positive difference favors surgical treatment.
Kalpesh Jani. Laparoscopic surgery was more effective than medical management for chronic gastroesophageal reflux disease. Ann Intern Med. 2009;150:JC1–12. doi: 10.7326/0003-4819-150-2-200901200-02012
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Published: Ann Intern Med. 2009;150(2):JC1-12.
Esophageal Disorders, Gastroenterology/Hepatology, Gastroesophageal Reflux Disease, Peptic Disease.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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