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Prophylactic mesh placement to prevent parastomal hernia, early results of a prospective multicentre randomized trial

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Abstract

Purpose

Parastomal hernia (PSH) is a common complication after colostomy formation. Recent studies indicate that mesh implantation during formation of a colostomy might prevent a PSH. To determine if placement of a retromuscular mesh at the colostomy site is a feasible, safe and effective procedure in preventing a parastomal hernia, we performed a multicentre randomized controlled trial in 11 large teaching hospitals and three university centres in The Netherlands.

Methods

Augmentation of the abdominal wall with a retromuscular light-weight polypropylene mesh (Parietene Light™, Covidien) around the trephine was compared with traditional colostomy formation. Patients undergoing elective open formation of a permanent end-colostomy were eligible. 150 patients were randomized between 2010 and 2012. Primary endpoint of the PREVENT trial is the incidence of parastomal hernia. Secondary endpoints are morbidity, pain, quality of life, mortality and cost-effectiveness. This article focussed on the early results of the PREVENT trial and, therefore, operation time, postoperative morbidity, pain, and quality of life were measured.

Results

Outcomes represent results after 3 months of follow-up. A total of 150 patients were randomized. Mean operation time of the mesh group (N = 72) was significantly longer than in the control group (N = 78) (182.6 vs. 156.8 min; P = 0.018). Four (2.7 %) peristomal infections occurred of which one (1.4 %) in the mesh group. No infection of the mesh occurred. Most of the other infections were infections of the perineal wound, equally distributed over both groups. No statistical differences were discovered in stoma or mesh-related complications, fistula or stricture formation, pain, or quality of life.

Conclusions

During open and elective formation of an end-colostomy, primary placement of a retromuscular light-weight polypropylene mesh for prevention of a parastomal hernia is a safe and feasible procedure.

The PREVENT trial is registered at: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2018.

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Acknowledgments

Sources of funding: Surgical Research Fund, Canisius Wilhelmina Hospital, Nijmegen. ZonMW, The Netherlands Organization for Health Research and Development Project number 170991011. Covidien.

Further collaborators

JA Charbon MD1, MF Gerhards MD, PhD2, IHJT de Hingh MD, PhD3, H van Haaren- de Haan4, PJ Tanis MD, PhD5, JF Lange MD, PhD6. 1Department of Surgery, Maxima Medical Centre, Veldhoven, the Netherlands. 2Department of Surgery, OLVG, Amsterdam, the Netherlands. 3Department of surgery, Catherina Hospital, Eindhoven, The Netherlands. 4Department of Surgery, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands. 5Department of surgery, Amsterdam Medical Centre, Amsterdam, The Netherlands. 6Department of surgery, Erasmus Medical Centre, Rotterdam, The Netherlands.

Author information

Authors and Affiliations

  1. Department of Surgery, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SZ, Nijmegen, The Netherlands

    H. T. Brandsma, B. M. E. Hansson, R. P. Bleichrodt & C. Rosman

  2. Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands

    T. J Aufenacker

  3. Department of Surgery, Isala Clinics, Zwolle, The Netherlands

    D. van Geldere

  4. Department of Surgery, Slingeland Hospital, Doetinchem, The Netherlands

    F. M. van Lammeren

  5. Department of Surgery, Albert Schweitzer Hospital, Dordrecht, The Netherlands

    C. Mahabier

  6. Department of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands

    P. Steenvoorde

  7. Department of Surgery, Elkerliek Hospital, Helmond, The Netherlands

    T. S. de Vries Reilingh

  8. Department of Surgery, St Antonius Hospital, Nieuwegein, The Netherlands

    R. J. Wiezer

  9. Department of Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands

    J. H. W. de Wilt

Authors
  1. H. T. Brandsma
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  2. B. M. E. Hansson
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  3. T. J Aufenacker
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  4. D. van Geldere
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  5. F. M. van Lammeren
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  6. C. Mahabier
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  7. P. Steenvoorde
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  8. T. S. de Vries Reilingh
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  9. R. J. Wiezer
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  10. J. H. W. de Wilt
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  11. R. P. Bleichrodt
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  12. C. Rosman
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Corresponding author

Correspondence to H. T. Brandsma.

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Conflict of interest

TA declares no conflict of interest. RB declares no conflict of interest. TB declares conflict of interest directly related to the submitted work; grants from ZonMw and from Covidien, during the conduct of the study. TdVR declares no conflict of interest. JdW declares no conflict of interest. BH declares conflict of interest directly related to the submitted work; grants from ZonMw and from Covidien, during the conduct of the study. CM declares no conflict of interest. CR declares conflict of interest directly related to the submitted work; grants from ZonMw and from Covidien, during the conduct of the study. PS declares no conflict of interest. FvL declares no conflict of interest. DvG declares no conflict of interest. RW declares no conflict of interest.

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On behalf of the Dutch Prevent Study group.

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Brandsma, H.T., Hansson, B.M.E., Aufenacker, T.J. et al. Prophylactic mesh placement to prevent parastomal hernia, early results of a prospective multicentre randomized trial. Hernia 20, 535–541 (2016). https://doi.org/10.1007/s10029-015-1427-9

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  • DOI: https://doi.org/10.1007/s10029-015-1427-9

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