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Randomized Controlled Trial
. 2011 Aug;25(8):2547-54.
doi: 10.1007/s00464-011-1585-5. Epub 2011 Apr 22.

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

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Randomized Controlled Trial

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

Mehran Anvari et al. Surg Endosc. .

Abstract

Background: A randomized controlled trial (RCT) investigated patients with gastroesophageal reflux disease (GERD) who were stable and symptomatically controlled with long-term medical therapy to compare ongoing optimized medical therapy with laparoscopic Nissen fundoplication (LNF).

Methods: Of the 180 patients eligible for randomization, 104 gave informed consent, and 3 withdrew from the study immediately after randomization. The patients randomized to medical therapy received optimized treatment with proton pump inhibitors (PPIs) using a standardized management protocol based on best evidence and published guidelines. The surgical patients underwent LNF by one of four surgeons using a previously published technique. The patients underwent symptom evaluation using the GERD symptom scale (GERSS) and the global visual analog scale (VAS) for overall symptom control. They had 24-h esophageal pH monitoring at baseline and after 3 years. The medical patients were evaluated receiving PPI, and the surgical patients were evaluated not receiving PPI.

Results: For the 3-year follow-up assessment, 93 patients were available. At 3 years, surgery was associated with more heartburn-free days, showing a mean difference of -1.35 days per week (p = 0.0077) and a lower VAS score (p = 0.0093) than medical management. Surgical patients reported improved quality of life on the general health subscore of the Medical Outcomes Survey Short Form 36 (SF-36) at 3 years, with a mean difference of -12.19 (p = 0.0124). The groups did not differ significantly in terms of GERSS or acid exposure on 24-h esophageal pH monitoring at 3 years. There were six treatment failures (11.8%) in the surgical group and eight treatment failures (16%) in the medical group by 3 years.

Conclusions: For patients whose GERD symptoms are stable and controlled with PPI, continuing medical therapy and laparoscopic antireflux surgery are equally effective, although surgery may result in better symptom control and quality of life.

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