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Use of a bioabsorbable mesh in midline laparotomy closure to prevent incisional hernia: randomized controlled trial

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Abstract

Introduction

The objective was to assess the effectiveness and safety of a bioabsorbable mesh at the time of closure of a midline laparotomy for IH prevention.

Materials and Methods

A multicenter, randomized clinical trial including patients undergoing abdominal surgical procedures through a midline laparotomy incision was designed. In the group of mesh (n = 167) the incision was closed using a continuous polydioxanone suture (PDS) plus a bioabsorbable mesh. In the control group (n = 165) a continuous PDS single layer suture was only used. Patients were randomly assigned (1:1) to the two groups. The primary outcome was the incidence of IH at 6, 12 and 24 months. Assessment of IH was done using a CT scan.

Results

At 6 months, the rates of IH were 15.2% and 24.8% in the experimental and control groups, respectively (relative risk [RR] 0.66, 95% confidence interval [CI] 0.38-0.98, P = 0.042). At 12 months, the rate of IH continued to be significantly lower in the experimental group (21.4% vs. 33.1%, P = 0.033), but at 24 months, there were no significant differences between the study groups with a follow-up rate of only 37.5%. The number needed to treat (NNT) was 11 and 9 at 6 and 12 months, respectively.

Conclusion

The bioabsorbable mesh significantly prevented IH during the first year. Not reliable conclusions can be drawn across the second year. This may suggest that the any of the closing technique assessed in this study would have a “palliative” transient effect for preventing IH in the long-term.

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Acknowledgements

We thank Marta Pulido, MD, PhD, for editing the manuscript and editorial assistance.

Funding

The trial is an investigator-initiated study supported in part by W.L. Gore and Associates, S.L. (PR [AG] 220/2013) without scientific influence.

Author information

Authors and Affiliations

  1. Unit of Abdominal Wall Surgery, Service of Digestive and General Surgery, Hospital Universitari Vall D’Hebron, Universitat Autònoma de Barcelona, Passeig Vall d’Hebron 119-129, 08035, Barcelona, Spain

    S. Valverde, V. Rodrigues, M. Armengol & M. López-Cano

  2. Vall D’Hebron Research Institute General and Gastrointestinal Surgery Research Group, Hospital Universitari Vall D’Hebron, Barcelona, Spain

    M. A. Arbós, M. T. Quiles, E. Espín, J. L. Sánchez-Garcia, V. Rodrigues, M. Armengol & M. López-Cano

  3. Unit of Colorectal Surgery, Service of General and Digestive Surgery, Hospital Universitari Vall D’Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain

    E. Espín & J. L. Sánchez-Garcia

  4. Service of General and Digestive Surgery, Department of Health and Experimental Sciences, Hospital del Mar, Universitat Pompeu Fabra, Parc de Salut Mar, Barcelona, Spain

    J. A. Pereira

  5. Service of General and Digestive Surgery, Hospital Arnau de Vilanova, Universitat de Lleida, Lleida, Spain

    R. Villalobos

  6. Grupo de Investigación Salud Global, Género Y Sociedad (GHenderS), Blanquerna-Universitat Ramon Llull, Barcelona, Spain

    J. M. García-Alamino

  7. Programme in Evidence Based Health Care, University of Oxford, Oxford, UK

    J. M. García-Alamino

Authors
  1. S. Valverde
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  8. R. Villalobos
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  9. J. M. García-Alamino
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  10. M. Armengol
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  11. M. López-Cano
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Contributions

Silvia Valverde contributed to collected data, analyze data, interpreted the results, revised the manuscript for intellectual content, and approved the final draft. Maria Antonia Arbós participated in the collection of data, search and review of the literature, analysis of results, review of the manuscript, and approved the final draft. Maria Teresa Quiles participated in the collection of data, search and review of the literature, analysis of results, review of the manuscript, and approved the final draft. Eloy Espín contributed to search of the literature, interpretation of results and approval of the final draft. Jose Luis Sánchez contributed to search of the literature, interpretation of results and approval of the final draft. Victor Rodrigues contributed to collection data, search of the literature, interpretation of results and approval of the final draft. Jose Antonio Pereira contributed to collection data, interpretation of results and approval of the final draft. Rafael Villalobos contributed to collection data, interpretation of results and approval of the final draft. Josep M García-Alamino participated in the collection of data, search and review of the literature, analysis of results, review of the manuscript, and approved the final draft. Manuel Armengol contributed to search of the literature, interpretation of results and approval of the final draft. Manuel López-Cano was the principal investigator and the trial coordinator, designed the study, collected data, contributed to statistical analysis, and drafted the manuscript. He was also responsible for editorial decisions including the selection of the journal.

Corresponding author

Correspondence to M. López-Cano.

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Conflict of interests

López-Cano has received honoraria for consultancy, lectures, support for travels and participation in review activities from BD-Bard, Medtronic and Gore. S Valverde, MA Arbós, MT Quiles, E Espin, JL Sanchez-García, V Rodrigues, JA Pereira, R Villalobos, JM García-Alamino and M Armengol have no conflicts of interest or financial ties to disclose.

Ethical approval

The study was approved by the Ethics Committee of Clinical Research of Hospital Universitari Vall d’Hebron (PR [AG] 220/2013).

Human and animal rights

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

Informed consent

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

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Valverde, S., Arbós, M.A., Quiles, M.T. et al. Use of a bioabsorbable mesh in midline laparotomy closure to prevent incisional hernia: randomized controlled trial. Hernia 26, 1231–1239 (2022). https://doi.org/10.1007/s10029-021-02435-3

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