A prospective, randomized trial of laparoscopic polytetrafluoroethylene (PTFE) patch repair vs simple cruroplasty for large hiatal hernia.

Hypothesis: Large hiatal hernias are prone to disruption, resulting in reherniation, when repaired with simple cruroplasty. The use of mesh may decrease the rate of reherniation in the laparoscopic repair of large hiatal hernias.

Design: Prospective, randomized controlled trial.

Setting: University-affiliated private hospital.

Patients: Seventy-two individuals undergoing laparoscopic Nissen fundoplication with a hernia defect greater or equal to 8 cm in diameter.

Intervention: Nissen fundoplication with posterior cruroplasty (n = 36) vs Nissen fundoplication with posterior cruroplasty and onlay of polytetrafluoroethylene (PTFE) mesh (n = 36).

Main Outcome Measures: Recurrences, complications, hospital stay, operative time, and cost.

Results: Patients in both groups had similar hospital stays, but the PTFE group had a longer operative time. The cost of the repair was $960 +/- $70 more in the group with the prosthesis. Complications were minor and similar in both groups. There were 8 hernia recurrences (22%) in the primary repair group and none in the PTFE group (P<.006).

Conclusion: The use of prosthetic reinforcement of cruroplasty in large hiatal hernias may prevent hernia recurrences.