Perioperative risk of laparoscopic fundoplication: Safer than previously reported - Analysis of the American College of Surgeons National Surgical Quality Improvement Program 2005 to 2009

BACKGROUND: Several prospective randomized controlled trials show equal effectiveness of surgical fundoplication and proton pump inhibitor therapy for the treatment of gastroesophageal reflux disease. Despite this compelling evidence of its efficacy, surgical antireflux therapy is underused, occurring in a very small proportion of patients with gastroesophageal reflux disease. An important reason for this is the perceived morbidity and mortality associated with surgical intervention. Published data report perioperative morbidity between 3% and 21% and mortality of 0.2% and 0.5%, and current data are uncommon, largely from previous decades, and almost exclusively single institutional. STUDY DESIGN: The study population included all patients in the American College of Surgeons National Surgical Quality Improvement Program database from 2005 through 2009 who underwent laparoscopic fundoplication with or without related postoperative ICD-9 codes. Comorbidities, intraoperative occurrences, and 30-day postoperative outcomes were collected and logged into statistical software for appropriate analysis. Postoperative occurrences were divided into overall and serious morbidity. RESULTS: A total of 7,531 fundoplications were identified. Thirty-five percent of patients were younger than 50 years old, 47.1% were 50 to 69 years old, and 16.8% were older than 69 years old. Overall, 30-day mortality was 0.19% and morbidity was 3.8%. Thirty-day mortality was rare in patients younger than age 70 years, occurring in 5 of 10,000 (0.05%). Mortality increased to 8 of 1,000 (0.8%) in patients older than 70 years (p < 0.0001). Complications occurred in 2.2% of patients younger than 50 years, 3.8% of those 50 to 69 years, and 7.3% of patients older than 69 years. Serious complications occurred in 8 of 1,000 (0.8%) patients younger than 50 years, 1.8% in patients 50 to 69 years, and 3.9% of those older than 69 years. CONCLUSIONS: Analysis of this large cohort demonstrates remarkably low 30-day morbidity and mortality of laparoscopic fundoplication. This is particularly true in patients younger than 70 years, who are likely undergoing fundoplication for gastroesophageal reflux disease. These data suggest that surgical therapy carries an acceptable risk profile.