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Is absorbable mesh useful in preventing parastomal hernia after emergency surgery? The PARTHENOPE study

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Abstract

Purpose

Colostomy is a frequent event in oncological or inflammatory bowel diseases. Its related morbidity includes retraction, infection and parastomal hernia (PH), which is a quite common late complication. Several surgical options are available for PH repair, the majority including mesh. However, results are often disappointing with relevant recurrence rates, up to 33%. The study aim was to assess the feasibility and effectiveness of prophylactic biosynthetic mesh (BIO-A®, polyglycolide-trimethylene carbonate copolymer) placed during colostomy fashioning, in reducing PH. A prospective randomized controlled double-blind trial was conducted from January 2014 to December 2019 to compare conventional end-colostomy with end-colostomy reinforced with BIO-A mesh in ante-rectus position in patients undergoing colon diversion in emergency surgery.

Methods

Patients were clinically followed up at 3, 6, and 12 months and received a CT scan at 6 and 12 months. The postoperative morbidity and wound events were also evaluated.

Results

55 patients receiving conventional colostomy considered as Control Group and 55 patients receiving BIO-A mesh supported colostomy (Mesh Group) were included in the study. At 12 months, the incidence of PH was 9 (12.7%) and 24 (43.6%) in the Mesh Group and Control Group, respectively (p < 0.05). Postoperative morbidity was similar between Mesh Group and Control Group (7 [12.7%] vs 4 [7.3%], respectively; p = 0.340). The multivariable analysis showed that not using a mesh (p = 0.042), age > 70 years (p = 0.041), diabetes (p < 0.001), colon dilation > 7 cm (p < 0.0001) and COPD (p = 0.009) were all related with postoperative PH.

Conclusions

The prophylactic BIO-A mesh positioning during colostomy is an effective procedure reducing PH incidence at a 1 years follow-up guaranteeing low postoperative morbidity.

Study dataset is available on ClinicalTrials.gov ID

NCT04436887.

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Acknowledgements

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No funds were requested or obtained.

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Authors and Affiliations

Authors

Contributions

FP: Conceptualization, methodology, software, data curation, writing-original draft preparation. DD: Visualization, investigation. LB and LD: Supervision, FSL, ST: Software, validation, AM, CD and CG: Reviewing, editing.

Corresponding author

Correspondence to F. Pizza.

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Conflict of interest

The authors, Francesco Pizza PhD Md, Dario D’antonio Md, Francesco Saverio Lucido Md, Claudio Gambardella Md, Chiara dell’Isola Md, Salvatore Tolone Md, PhD, Ludovico Docimo, Md, Luigi Brusciano and Paolo Del Rio Md declare that they have no competing interests.

Ethical approval

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.

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Informed consent was obtained from all individual participants included in the study.

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Pizza, F., D’Antonio, D., Lucido, F.S. et al. Is absorbable mesh useful in preventing parastomal hernia after emergency surgery? The PARTHENOPE study. Hernia 26, 507–516 (2022). https://doi.org/10.1007/s10029-022-02579-w

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