Biologic Prosthesis Reduces Recurrence after Laparoscopic Paraesophageal Hernia Repair: A Multi-Center, Prospective, Randomized Trial
Brant K. Oelschlager, MD*, Carlos A. Pellegrini, MD, John Hunter, MD, Nathaniel J. Soper, MD, Michael Brunt, MD*, Brett Sheppard, MD*, Blair Jobe, MD*, Nayak Polliser, PhD*, Lee Mitsumori, MD*, Lee Swanstrom, MD*
University of Washington, Seattle, WA, University of Washington, Seattle, WA, Oregon Health Sciences University, Portland, OR, Northwestern University, Chicago, IL, Washington University, St. Louis, MO, Oregon Health Sciences Univesity, Portland, OR, Oregon Health Sciences University, Portland, OR, University of Washington, Seattle, WA, University of Washington, Seattle, WA, Oregon Clinic, Portland, OR
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.
* 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.
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