Background: Recent reports suggest that when laparoscopy is used to repair paraesophageal hernias recurrence rates reach 20% to 40%. Tension-free hernia closure with synthetic mesh reduces recurrence but occasionally results in esophageal injury-We hypothesized that reinforcement of the hiatal closure with small intestine submucosa (SIS) mesh, in some unusually large hernias, might reduce recurrence rates without causing injury to the esophagus. Methods: From January 2001 to March 2002 we treated 18 large paraesophageal hernias via a laparoscopic approach. In 9 of the largest hernias (one type II and 8 type III, of which 1 was recurrent) the repair was reinforced with SIS mesh (Surgisis, Cook Surgical) and represent the subjects of this study. Nissen fundoplication with gastropexy was performed in all patients. Clinical follow-up ranged from 3 to 16 months (median 8). Every patient was evaluated with barium esophagram or endoscopy or both 1 to 8 months (median 2) postoperatively. Results: The presenting symptoms were postprandial pain/fullness (9 of 9), heartburn (4 of 9), anemia (4 of 9), dysphagia Q of 9), regurgitation Q of 9), and chest pain Q of 9). One patient died of a hemorrhagic stroke within 30 days,of the operation. Postoperatively, presenting symptoms resolved (83%) or improved (17%) in each of the remaining 8 patients. One patient required endoscopic dilation for mild dysphagia. Seven of 8 patients had a normal barium esophagram without evidence of hernia. One morbidly obese (body mass index = 47) patient had a small (2 cm.) sliding hiatal hernia postoperatively. There were no other complications, and specifically no perforations or mesh erosions. Conclusions: These observations suggest that the use of SIS in the repair of paraesophageal hernias is safe and may reduce recurrence. Longer follow-up and a randomized study are needed to validate these results. (C) 2003 Excerpta Medica, Inc. All rights reserved.