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Prophylactic mesh to prevent parastomal hernia after end colostomy: a meta-analysis and trial sequential analysis

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Abstract

Purpose

Prevention of parastomal hernia (PSH) formation is crucial, given the high prevalence and difficulties in the surgical repair of PSH. To investigate the effect of a preventive mesh in PSH formation after an end colostomy, we aimed to meta-analyze all relevant randomized controlled trials (RCTs).

Methods

We searched five databases. For each trial, we extracted risk ratios (RRs) of the effects of mesh or no mesh. The primary outcome was incidence of PSH with a minimum follow-up of 12 months with a clinical and/or computed tomography diagnosis. RRs were combined using the random-effect model (Mantel–Haenszel). To control the risk of type I error, we performed a trial sequential analysis (TSA).

Results

Seven RCTs with low risk of bias (451 patients) were included. Meta-analysis for primary outcome showed a significant reduction of the incidence of PSH using a mesh (RR 0.43, 95% CI 0.26–0.71; P = 0.0009). Regarding TSA calculation for the primary outcome, the accrued information size (451) was 187.1% of the estimated required information size (RIS) (241). Wound infection showed no statistical differences between groups (RR 0.77, 95% CI 0.39–1.54; P = 0.46). PSH repair rate showed a significant reduction in the mesh group (RR 0.28 (95% CI 0.10–0.78; P = 0.01).

Conclusions

PSH prevention with mesh when creating an end colostomy reduces the incidence of PSH, the risk for subsequent PSH repair and does not increase wound infections. TSA shows that the RIS is reached for the primary outcome. Additional RCTs in the previous context are not needed.

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Acknowledgements

We thank the corresponding authors of the studies included in the meta-analysis for providing additional information and review of our data extraction from their studies. We thank Marta Pulido, MD, for editorial assistance.

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Author notes

    Authors and Affiliations

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

      M. López-Cano

    2. Department of Surgery, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands

      H.-T. Brandsma & B. Hansson

    3. Department Cardiac and Vascular Surgery, Medical University of Gdansk, Gdańsk, Poland

      K. Bury

    4. Department of Surgery, Maria Middelares Hospital, Ghent, Belgium

      I. Kyle-Leinhase & F. Muysoms

    5. Department of Primary Health Care Sciences, University of Oxford, Oxford, UK

      J. G. Alamino

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    1. M. López-Cano
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    4. B. Hansson
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    Correspondence to M. López-Cano.

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    Conflict of interest

    ML-C declares conflict of interest not directly related to the submitted work: personal fees (consultancy, speaker) from Johnson & Johnson and Bard-Davol. H-T B, KB, BH, IK-L and JGA declare that they have no conflict of interest. FM declares conflict of interest not directly related to the submitted work: grants and personal fees (consultancy, speaker) from Medtronic, Johnson & Johnson; B.Braun and DynaMesh, personal fees (speaker) from Bard-Davol, Cousin Biotech, WL GORE & Ass and Sofradim.

    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.

    Human and animal rights

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

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    For this type of study formal consent is not required.

    Additional information

    M. López-Cano and H.-T. Brandsma contributed equally to this study.

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    López-Cano, M., Brandsma, HT., Bury, K. et al. Prophylactic mesh to prevent parastomal hernia after end colostomy: a meta-analysis and trial sequential analysis. Hernia 21, 177–189 (2017). https://doi.org/10.1007/s10029-016-1563-x

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