OBJECTIVE: The authors examined indications, evaluations, and outcomes after laparoscopic fundoplication in patients with gastroesophageal reflux through this single-institution study. SUMMARY OF BACKGROUND DATA: Laparoscopic fundoplication has been performed for less than 5 years, yet the early and intermediate results suggest that this operation is safe and equivalent in efficacy to open techniques of antireflux surgery. METHODS: Over a 4-year period, 300 patients underwent laparoscopic Nissen fundoplication (252) or laparoscopic Toupet fundoplication (48) for gastroesophageal reflux refractory to medical therapy or requiring daily therapy with omeprazole or high-dose H2 antagonists. Preoperative evaluation included symptom assessment, esophagogastroduodenoscopy, 24-hour pH evaluation, and esophageal motility study. Physiologic follow-up included 24-hour pH study and esophageal motility study performed 6 weeks and 1 to 3 years after operation. RESULTS: The most frequent indication for surgery was the presence of residual typical and atypical gastroesophageal reflux symptoms (64%) despite standard doses of proton pump inhibitors. At preoperative evaluation, 51% of patients had erosive esophagitis, stricture, or Barrett's metaplasia. Ninety-eight percent of patients had an abnormal 24-hour pH study. Seventeen percent had impaired esophageal motility and 2% had aperistalsis. There were four conversions to open fundoplication (adhesions, three; large liver, one). Intraoperative technical difficulties occurred in 19(6%) patients and were dealt with intraoperatively in all but 1 patient (bleeding from enlarged left liver lobe). Minor complications occurred in 6% and major complications in 2%. There was no mortality. Median follow-up was 17 months. One year after operation, heartburn was absent in 93%. Four percent took occasional H2 antagonists, and 3% were back on daily therapy. Atypical reflux symptoms (e.g., asthma, hoarseness, chest pain, or cough) were eliminated or improved in 87% and no better in 13%. Overall patient satisfaction was 97%. Four patients have subsequently undergone laparotomy for repair of gastric perforation (1 year after operation), severe dumping, "slipped" Nissen, and repair of acute paraesophageal herniation. Two patients had laparoscopic revision of herniated fundoplications. Results of follow-up 24-hour pH studies were normal in 91% of patients more than 1 year after operation. In patients with poor esophageal motility, esophageal body pressure improved 1 year after operation in 75% and worsened in 10%. CONCLUSIONS: Although long-term efficacy data are lacking, intermediate follow-up shows laparoscopic fundoplication to be safe and effective. A physiologic approach to evaluation and follow-up of patients with gastroesophageal disease allows the surgeon to tailor antireflux surgery to esophageal body function and follow the function of the fundoplication and esophagus after operation.