Background/Aims: Primary repair of a large hiatal hernia is associated with a published recurrence rate of up to 10%; anecdotal rates even higher than this have been reported to the authors. The use of prosthetic material in the repair of other abdominal wall defects has often produced better results than primary repair. We wanted to compare laparoscopic primary repair of large hiatus hernias with laparoscopic primary repair reinforced with prosthetic. Methods: Thirty-one patients with symptomatic gastroesophageal reflux and a hiatal defect 8 cm or greater were randomized to Nissen fundoplication with posterior cruroplasty (n = 16) or Nissen cruroplasty, and onlay of polytetrafluoroethylene (PTFE) mesh (n = 15). All patients underwent preoperative esophagogastroduodenoscopy (EGD) and barium esophagography. After posterior cruroplasty with interrupted nonabsorbable suture, the mesh reinforcement group had an onlay of PTFE placed around the hiatus. A radial slit with 3 cm ‘keyhole’ (to accommodate the esophagus) was cut into the PTFE. The prosthetic was stapled to the diaphragm, and the two leaves of the slit were stapled to each other. All patients underwent EGD at 3 months and all had esophagrams every 6 months postoperatively. Follow-up ranged from 12 to 36 months. Results: Length of hospital stay was equal in both groups (2 days). The average cost to the patient with PTFE was USD 1,050 higher than to the patient with primary repair. There were 2 complications (1 pneumonia, 1 urinary retention) in the PTFE group, and 1 complication (pneumothorax) in the primary repair group. There were 3 recurrences (18.8%) in the primary group (p = 0.08, χ<sup>2</sup> test). Conclusion: The use of PFTE reinforcement for primary repair of large hiatal hernias may result in a lower rate of recurrent herniation compared to primary repair alone.
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