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Safety and efficacy of prophylactic resorbable biosynthetic mesh following midline laparotomy in clean/contemned field: preliminary results of a randomized double blind prospective trial

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Abstract

Background

Incisional hernia (IH) is one of the most common sequelae of laparotomy.

Materials and methods

We present a double-blind randomized study examining feasibility, safety and incisional hernia rate using a prophylactic Bio-A biosynthetic stripe (Gore) in a sub-lay position after midline laparotomy in patients undergoing operations in clean-contaminated and contaminated field. One hundred patients who underwent a midline laparotomy of at least 10 cm in a clean-contaminated and contaminated field were considered. Patients were divided into two groups: [Group A closed in double layer using PDS 0 with WL/SL of 1:4; Group B closure in double layer using PDS 0 and sub-lay positioning a 3 cm-wide BIO A (Gore) strip extended for the entire length of the incision]. The primary objective of the study was to identify IH rate in the two groups at 1- and 2-year follow-up. Secondary objective was to identify any differences in the two groups in terms of post-operative pain, morbidity and mortality.

Results

Out of a total of 100 patients included in the study, a 2-year follow-up was possible for 47 patients in group A and 45 in group B. The incidence of IH was 11/47 in group A (22%) and 3/45 in group B (6%) [p < 0.01]. Furthermore, no statistically significant difference was noted about post-operative morbidity and pain related to the wall closure method.

Conclusions

The prophylactic use of a BIO-A biosynthetic stripe (Gore) showed a statistically significant reduction in the incisional hernia rate in patients who underwent clean-contaminated and contaminated surgery.

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Authors and Affiliations

  1. ASL Napoli 2 Nord, Via Lupoli, 27, 80027, Frattamaggiore, Naples, Italy

    F. Pizza, D. D’Antonio & A. Marvaso

  2. AORN “A. Cardarelli”, Naples, Italy

    M. Arcopinto

  3. AORN Azienda Dei Colli “A. Cotugno”, Naples, Italy

    C. Dell’Isola

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  1. F. Pizza
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  2. D. D’Antonio
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  3. M. Arcopinto
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  4. C. Dell’Isola
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  5. A. Marvaso
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Correspondence to F. Pizza.

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The authors declare that they have no conflict of interest.

Ethical approval

This study was approved by the research ethics board of the ASL NApoli 2 Nord, Naples.

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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. This article does not contain any studies with animals performed by any of the authors.

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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., Arcopinto, M. et al. Safety and efficacy of prophylactic resorbable biosynthetic mesh following midline laparotomy in clean/contemned field: preliminary results of a randomized double blind prospective trial. Hernia 24, 85–92 (2020). https://doi.org/10.1007/s10029-019-02025-4

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