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Objective:

Laparoscopic paraesophageal hernia repair (LPEHR) is associated with a high recurrence rate. Repair with synthetic mesh lowers recurrence but can cause dysphagia and visceral erosions. This trial was designed to study the value of a biologic prosthesis, small intestinal submucosa (SIS), in LPEHR.

Methods:

Patients undergoing LPEHR (n= 108) at 4 institutions were randomized to primary repair− 1 (n= 57) or primary repair buttressed with SIS (n= 51) using a standardized technique. The primary outcome measure was evidence of recurrent hernia (≥ 2 cm) on UGI, read by a study radiologist blinded to the randomization status, 6 months after operation.

Results:

At 6 months, 99 (93%) patients completed clinical symptomatic follow-up and 95 (90%) patients had an UGI. The groups had similar clinical presentations (symptom profile, quality of life, type and size of hernia, esophageal length, and BMI …