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 -1º- (n=57) or primary repair buttressed with SIS (n=51) using a standardized technique. The primary outcome measure was evidence of recurrent hernia (> 2cm) on UGI, read by a study radiologist blinded to the randomization status, 6 months after operation.
RESULTS: At 6 months, 100 (94%) completed clinical symptomatic follow-up and 94 (90%) had an UGI.
Peri-operative Outcomes: The SIS group had larger anterior-posterior hernia diameter, but similar esophageal length. Operative times (SIS 202 min vs. 1º 183 min, p=0.15) and peri-operative complications did not differ. There were no operations for recurrent hernia nor mesh related complications.
Primary Outcome: At 6 months, 3 patients (7%) developed a recurrent hernia > 2 cm in the SIS and 12 patients (25%) in the 1º group.
Secondary Outcomes: Both groups experienced a significant reduction in all measured symptoms (heartburn, dysphagia, regurgitation, chest and post-prandial (PP) pain) after operation. There was no difference between groups in either pre or post-operative symptom severity.

	Heartburn Pre-op	Heartburn post-op	PP pain pre-op	PP pain post-op	Dysphagia Post-op	A-P Hernia Diameter	Recurrent Hernia (>2cm)
1º	5.1	0.4*	4.4	1.1*	0.7	5.8 cm	25%
SIS	5.2	1.0*	4.9	1.5*	1.5	6.4 cm†	7%†

* Pre-op vs. Post-op, p<0.01
† 1º Repair vs. SIS p<0.05
Symptoms score: visual analog scale (0-10)
CONCLUSIONS: Adding a biologic prosthesis during LPEHR reduces the likelihood of recurrence, without mesh related complications or side effects.