Mid-term safety profile evaluation of Bio-A absorbable synthetic mesh as cruroplasty reinforcement
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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.
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).
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.
KeywordsMesh on the hiatus Hiatal hernia repair with mesh Synthetic bio-absorbable mesh Obesity Risk factors hernia recurrence
Compliance with ethical standards
Dr Angelo Iossa and Prof. Gianfranco Silecchia have no conflicts of interest or financial ties to disclose.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
For this type of study formal consent is not required.
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