Transoral Incisionless Fundoplication and Laparoscopic Nissen Fundoplication Provide Similar Improvements in Reflux Disese-specific Quality of Life: A 1 Year Case Control Study

Matthew R Pittman1, Jennifer S Schwartz1, Sara E Martin del Campo1, W. Scott Melvin2, Kyle A Perry1. 1The Ohio State University Medical Center, 2Montefiore Medical Center

INTRODUCTION: Laparoscopic Nissen fundoplication (LNF) is the standard of care for surgical management of gastroesophageal reflux disease (GERD). Transoral incisionless fundoplication (TIF) offers an endoscopic alternative that enhances the gastroesophageal flap valve and may represent a more physiologic antireflux barrier. To date, studies comparing these procedures are lacking. The objective of this study was to compare the efficacy and side effects associated with LNF and TIF in patients with symptomatic GERD.

METHODS AND PROCEDURES: We performed a review of all patients undergoing LNF and TIF for objectively confirmed GERD between 2010 and 2014. Patients with hiatal hernias larger than 2 centimeters, esophageal strictures, Los Angeles class C or D esophagitis, or Barrett’s esophagus were excluded from the study. Reflux symptoms and quality of life were assessed using the Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) questionnaire. Dysphagia and bloating were measured on a 5 point Likert scale. Baseline and initial post-operative data were collected in the clinic setting. Follow-up was obtained by telephone questionnaire, with a median follow-up interval of 12 (6-48) months. Data are presented as incidence (%), mean ± SD, or median (range) as appropriate, and a p-value of <0.05 was considered statistically significant.

RESULTS: During the study period, 42 patients underwent LNF and 19 underwent TIF. The groups did not differ in terms of age (48 versus 48, p=0.87), gender (69% female versus 53%, p=0.26), BMI (27 versus 29, p=0.33), hiatal hernia (57% versus 53%, p=0.79), esophagitis (28% versus 26%, p=1.0), DeMeester score (40 versus 43, p=0.57) or GERD symptoms scores. Preoperative symptoms were also similar for significant heartburn (75.0% versus 66.7%, p=0.71) and bloating (65.6% versus 66.7, p=1.0). LNF required 84±3 minutes to perform compared to 56±3 minutes for TIF (p<0.01), and median length of stay was 1 day for both procedures (p=0.09). Complications occurred in 1 (2%) patient following LNF and 2 (10%) following TIF, including one esophageal leak requiring thoracotomy and decortication. GERD-HRQL improved significantly following both LNF (31.5 to 4, p<0.01) and TIF (24.5 to 3.5, p<0.01), with no difference in the postoperative scores (p=0.90). At follow-up, 12% of patients were using anti-secretory medications compared to 23% following TIF (p=0.39). Twenty-eight percent of patients following LNF reported significant dysphagia at follow-up compared to 8% of TIF patients (p=0.23). Significant bloating occurred in 52% and 17% of patients respectively (p=0.07). Both LNF and TIF were associated with high rates of patient satisfaction (84% and 92% p=0.629).

Conclusion: TIF produces similar improvements in disease-specific quality of life as those seen with LNF and both procedures are associated with high levels of patient satisfaction at 1 year follow-up. Though a higher proportion of patients following TIF tend to require anti-secretory medications, there is a trend toward decreased rates of post-operative bloating and dysphagia. TIF is associated with shorter operative times than LNF and a short length of hospital stay, but it is a surgical procedure that has potential for serious complications. Finally, larger follow-up studies are required to establish the long-term efficacy of TIF.

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