Mid-term safety profile evaluation of Bio-A absorbable synthetic mesh as cruroplasty reinforcement.

PURPOSE

The aim of the present paper is to report the results of a single institution series of hiatal hernia repair (HHR) with augmented mesh hiatoplasty focusing on safety and efficacy profile of Bio-A absorbable synthetic mesh.

MATERIALS AND METHODS

A retrospective evaluation of prospectively maintained database showed 120 consecutive patients submitted to HHR reinforced with bio-absorbable synthetic mesh. The study populations included two groups: (A) 92 obese patients-reinforced hiatoplasty concurrent with bariatric procedure; (B) 28 non-obese patients-reinforced hiatoplasty concurrent with antireflux surgery. Symptoms assessment was made with GERD-HRQL and Rome III. The X-ray with barium swallow, the CT scan, in selected cases, and the endoscopy were used as recurrence evaluation and as endoscopic complications assessment. Only patients with a mean follow-up of 12 months were included in this study. A Cox hazard was made to evaluate factors affecting the recurrence.

RESULTS

No case of intra-peri and post-operative (mean follow-up of 41 months) complications mesh related were registered. The dysphagia-rate was 8.7% for Group A and 11% for Group B. 74% of Group A and 61% of Group B patients are actually PPIs free with median GERD-HRQL score of 4 (from 16) and 6 (from 23), respectively (difference pre-post-operative < 0.05). Recurrence rate was 5.4% in Group A and 7.1% in Group B. The Cox hazard analysis showed that the use of more than four stitches for cruroplasty represents a negative factor on recurrence (HR = 8; p < 0.05).

CONCLUSIONS

This is, in our knowledge, the largest report (120 consecutive patients) with mid-term follow-up (41 months of mean FU) on bio-absorbable mesh on the hiatus in obese and non-obese patients. These results supports the use of absorbable mesh for HHR (safe profile-0% of complications rate), showing excellent recurrence rate results and good GERD symptoms control.