Purpose: Recurrence remains a major challenge after minimally invasive hiatus hernia (HH) repair, particularly in patients with large diaphragmatic defects. Currently, biosynthetic absorbable meshes such as Bio-A® and Phasix™ ST are widely used to reinforce cruroplasty, however evidence comparing their efficacy and safety profile remains limited. This study aims to compare the safety and efficacy of Bio-A® versus Phasix™ ST after minimally invasive HH repair through a Bayesian meta-analysis. Methods: Systematic search across online databases up to November 2025 was performed. Inclusion criteria targeted elective minimally invasive HH repairs with Bio-A® or Phasix™ ST mesh. Primary outcome was radiologically or endoscopically confirmed anatomical HH recurrence. Overall, severe (Clavien-Dindo ≥ 3), mesh-related complications and reoperation for recurrence were secondary outcomes. A Bayesian hierarchical power prior model was utilised to pool data from both comparative and single-arm studies. Results: Twenty-one observational studies (2208 patients) were included. Bio-A® was used in 53.1% of cases. The overall recurrence rate was 8.2% (n = 170 patients), with a clinical trend toward higher recurrence for Bio-A® vs. Phasix™ ST mesh (10% vs. 6%). The Bayesian meta-analysis showed no statistically significant difference for Bio-A® vs. Phasix™ ST (RR = 1.29, 95% HPD 0.01–8.15). Notably, 38 over 170 patients (17%) required reoperation for HH recurrence with a trend toward higher rates for Bio-A® vs. PhasixTM (36.3% vs. 19.3%). Overall (RR = 1.16, 95% HPD 0.01–8.75) and severe postoperative complications (RR = 1.06, 95% HPD 0.01–12.33) were comparable. Mesh-related complication with esophageal fibrosis occurred in one Bio-A® patient (0.04%). Conclusion: Bio-A® and Phasix™ ST synthetic absorbable meshes seem safe and effective for hiatal reinforcement with apparently similar rates of recurrence and postoperative morbidity. The choice between these materials should be guided by surgeon preferences and cost-effectiveness.
Efficacy and safety of mesh reinforced cruroplasty with Phasix™ ST vs. Bio-A®: systematic review and bayesian meta-analysis
Bonavina L.;
2026-01-01
Abstract
Purpose: Recurrence remains a major challenge after minimally invasive hiatus hernia (HH) repair, particularly in patients with large diaphragmatic defects. Currently, biosynthetic absorbable meshes such as Bio-A® and Phasix™ ST are widely used to reinforce cruroplasty, however evidence comparing their efficacy and safety profile remains limited. This study aims to compare the safety and efficacy of Bio-A® versus Phasix™ ST after minimally invasive HH repair through a Bayesian meta-analysis. Methods: Systematic search across online databases up to November 2025 was performed. Inclusion criteria targeted elective minimally invasive HH repairs with Bio-A® or Phasix™ ST mesh. Primary outcome was radiologically or endoscopically confirmed anatomical HH recurrence. Overall, severe (Clavien-Dindo ≥ 3), mesh-related complications and reoperation for recurrence were secondary outcomes. A Bayesian hierarchical power prior model was utilised to pool data from both comparative and single-arm studies. Results: Twenty-one observational studies (2208 patients) were included. Bio-A® was used in 53.1% of cases. The overall recurrence rate was 8.2% (n = 170 patients), with a clinical trend toward higher recurrence for Bio-A® vs. Phasix™ ST mesh (10% vs. 6%). The Bayesian meta-analysis showed no statistically significant difference for Bio-A® vs. Phasix™ ST (RR = 1.29, 95% HPD 0.01–8.15). Notably, 38 over 170 patients (17%) required reoperation for HH recurrence with a trend toward higher rates for Bio-A® vs. PhasixTM (36.3% vs. 19.3%). Overall (RR = 1.16, 95% HPD 0.01–8.75) and severe postoperative complications (RR = 1.06, 95% HPD 0.01–12.33) were comparable. Mesh-related complication with esophageal fibrosis occurred in one Bio-A® patient (0.04%). Conclusion: Bio-A® and Phasix™ ST synthetic absorbable meshes seem safe and effective for hiatal reinforcement with apparently similar rates of recurrence and postoperative morbidity. The choice between these materials should be guided by surgeon preferences and cost-effectiveness.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
