Evidence map›Paper›PMID 41984260›Full record

SynthesisHernia : the journal of hernias and abdominal wall surgery2026

Efficacy and safety of mesh reinforced cruroplasty with Phasix™ ST vs. Bio-A

Michele Manara, Davide Bona, Sara De Bernardi, Marta Cavalli, Quan Wang, Gianluca Bonitta, Davide Guido, Antonio Biondi, Giampiero Campanelli, Luigi Bonavina and 1 more

Abstract readSystematic ReviewMeta-AnalysisComparative Study
In one paragraph

Synthesis in Hernia : the journal of hernias and abdominal wall surgery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Michele ManaraI.R.C.C.S. Ospedale Galeazzi - Sant'Ambrogio, Division of General Surgery, Department of Biomedical Science for Health, University of Milan, Milan, 20122, Italy.
Davide BonaI.R.C.C.S. Ospedale Galeazzi - Sant'Ambrogio, Division of General Surgery, Department of Biomedical Science for Health, University of Milan, Milan, 20122, Italy. davide.bona@unimi.it.ORCID http://orcid.org/0000-0003-4501-1187
Sara De BernardiI.R.C.C.S. Ospedale Galeazzi - Sant'Ambrogio, Division of General Surgery, Department of Biomedical Science for Health, University of Milan, Milan, 20122, Italy.
Marta CavalliUniversity of Insubria, Galeazzi-Sant'Ambrogio Hospital, Milan, Italy.
Quan WangDepartment of Pharmacy, Health and Nutrition Sciences, University of Calabria (UNICAL), Arcavacata di Rende (Cosenza), Azienda Ospedaliera di Cosenza, Division of General and Foregut Surgery, Cosenza, Italy.
Gianluca BonittaI.R.C.C.S. Ospedale Galeazzi - Sant'Ambrogio, Division of General Surgery, Department of Biomedical Science for Health, University of Milan, Milan, 20122, Italy.
Davide GuidoNational Institute of Gastroenterology - I.R.C.C.S. "Saverio de Bellis", Division of Data Science, Castellana Grotte, Bari, 70013, Italy.
Antonio BiondiG. Rodolico Hospital, Surgical Division, Department of General Surgery and Medical Surgical Specialties, University of Catania, Catania, 95131, Italy.
Giampiero CampanelliUniversity of Insubria, Galeazzi-Sant'Ambrogio Hospital, Milan, Italy.
Luigi BonavinaDepartment of Pharmacy, Health and Nutrition Sciences, University of Calabria (UNICAL), Arcavacata di Rende (Cosenza), Azienda Ospedaliera di Cosenza, Division of General and Foregut Surgery, Cosenza, Italy.
Alberto AiolfiI.R.C.C.S. Ospedale Galeazzi - Sant'Ambrogio, Division of General Surgery, Department of Biomedical Science for Health, University of Milan, Milan, 20122, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeRecurrence 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.

methodsSystematic 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.

resultsTwenty-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%).

conclusionBio-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.

Indexed as

Hernia, HiatalHerniorrhaphySurgical MeshBayes TheoremHumansPostoperative ComplicationsRecurrenceReoperationTreatment OutcomeBayesian meta-analysisBio-AHiatal herniaMesh repairPhasix STRecurrence

Identifiers

PMID41984260
PMCPMC13083453

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.