Efficacy and safety of mesh reinforced cruroplasty with Phasix™ ST vs. Bio-A®: systematic review and bayesian meta-analysis.
- 2026-04-15
- Hernia : the journal of hernias and abdominal wall surgery 30(1)
- Michele Manara
- Davide Bona
- Sara De Bernardi
- Marta Cavalli
- Quan Wang
- Gianluca Bonitta
- Davide Guido
- Antonio Biondi
- Giampiero Campanelli
- Luigi Bonavina
- Alberto Aiolfi
- PubMed: 41984260
- DOI: 10.1007/s10029-026-03666-y
Study Design
- Type
- Meta-Analysis
- Sample size
- n = 2,208
- Population
- patients undergoing elective minimally invasive hiatus hernia repair with Bio-A® or Phasix™ ST mesh
- Methods
- Systematic review and Bayesian meta-analysis of observational studies comparing Bio-A® vs Phasix™ ST mesh in minimally invasive hiatus hernia repair
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.