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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

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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Acknowledgments

We thank the following individuals for their contributions to this study: Lianna Butler and Sonja DePauw (study coordination), Drs. Cliff Sample, Herawaty Sebajang, and Laurent Biertho (patient care), Drs. Margherita Cadeddu and Robert Goodacre (Safety Monitoring Board), Leslie Deluca, Meredine Haynes, Jennifer McGugan, and Denise Stys Norman (data collection and patient follow-up), Paula McKay, and Karen Barlow (manuscript preparation), and Dr. Gary Foster (data management and detailed statistical analysis).This study was supported by grants from the Canadian Institute of Health Research and the Ontario Ministry of Health and Long-term Care.

Disclosures

Mehran Anvari, Christopher Allen, John Marshall, David Armstrong, Ron Goeree, Wendy Ungar, and Charles Goldsmith have no conflicts of interest or financial ties to disclose.

Author information

Correspondence to Mehran Anvari.

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Anvari, M., Allen, C., Marshall, J. et al. 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. Surg Endosc 25, 2547–2554 (2011). https://doi.org/10.1007/s00464-011-1585-5

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Keywords

  • Gastroesophageal reflux disease
  • GERD
  • Laparoscopic antireflux surgery
  • Laparoscopic Nissen fundoplication
  • Medical therapy
  • Proton pump inhibitors