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Parastomal hernia prevention using a novel collagen implant: a randomised controlled phase 1 study

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Abstract

Background

Parastomal hernias can be prevented or repaired using synthetic mesh; however, reported complications include infection, fibrosis and potential bowel erosion. The study aim was to assess the safety, feasibility and potential efficacy of using a prophylactic collagen implant.

Methods

Twenty patients undergoing defunctioning stomas were randomised to a conventional procedure or reinforcement with the implant. Follow-up included regular symptom questionnaires, clinical examination, stoma site ultrasound, and serum inflammatory markers.

Results

Ten patients (four males; mean BMI 26.3) had a conventional stoma, and ten (three males; mean BMI 26.3) received the implant. At a median of 6.5 months follow-up, a parastomal hernia was clinically evident in three of ten patients without the implant, and in none of ten patients with the implant. There were no clinical complications, ultrasound evidence of chronic seromas or serological evidence of a systemic inflammatory response.

Conclusions

Xenogeneic collagen has been demonstrated to aid soft tissue reinforcement. In this study, in contrast to published data relating to the use of conventional synthetic mesh, there were no complications related to infection or the implant’s proximity to the bowel. This trial demonstrates that the implant is safe, feasible to use and has the potential to prevent parastomal herniation.

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References

  1. Carne PW, Robertson GM, Frizelle FA (2003) Parastomal hernia. Br J Surg 90:784–793

    Article  PubMed  CAS  Google Scholar 

  2. Israelsson LA (2005) Preventing and treating parastomal hernia. World J Surg 29:1086–1089

    Article  PubMed  Google Scholar 

  3. Pearl RK (1989) Parastomal hernias. World J Surg 13:569–572

    Article  PubMed  CAS  Google Scholar 

  4. McGrath A, Porrett T, Heyman B (2006) Parastomal hernia: an exploration of the risk factors and the implications. Br J Nurs 15:317–321

    PubMed  Google Scholar 

  5. Cuthbertson AM, Collins JP (1947) Strangulated para-ileostomy hernia. Aust N Z J Surg 47:86–87

    Article  Google Scholar 

  6. Gabriel WB, Lloyd-Davies OV (1935) Colostomy. Br J Surg 22:520–538

    Article  Google Scholar 

  7. Goligher JC, Lloyd-Davies OV, Robertson CT (1951) Small-gut obstructions following combined excision of the rectum with special reference to strangulation round the colostomy. Br J Surg 38:467–473

    Article  PubMed  CAS  Google Scholar 

  8. Janes, Cengiz Y, Israelsson LA (2004) Randomised clinical trial of the use of a prosthetic mesh to prevent parastomal hernia. Br J Surg 91:280–282

    Article  PubMed  CAS  Google Scholar 

  9. Martin L, Foster G (1996) Parastomal hernia—review. Ann R Coll Surg Engl 78:81–84

    PubMed  CAS  Google Scholar 

  10. Marimuthu K, Vijayasekar C, Ghosh D, Mathew G (2006) Prevention of parastomal hernia using preperitoneal mesh: a prospective observational study. Colorectal Dis 8:672–675

    Article  PubMed  CAS  Google Scholar 

  11. Gogenur I, Mortensen J, Harvald T, Rosenberg J, Fischer A (2006) Prevention of parastomal hernia by placement of a polypropylene mesh at the primary operation. Dis Colon Rectum 49:1131–1135

    Article  PubMed  Google Scholar 

  12. Stoppa R (2003) About biomaterials and how they work in groin hernia repairs. Hernia 7:57–60

    Article  PubMed  CAS  Google Scholar 

  13. Rodgers BM, Maher JW, Talbert JL (1981) The use of preserved human dura for closure of abdominal wall and diaphragmatic defects. Ann Surg 193:606–611

    Article  PubMed  CAS  Google Scholar 

  14. Kaufman Z, Engelberg M, Zager M (1981) Fecal fistula: a late complication of Marlex mesh repair. Dis Colon Rectum 24:543–544

    Article  PubMed  CAS  Google Scholar 

  15. Stone HH, Fabian TC, Turkelson ML, Jurkiewicz MJ (1981) Management of acute full-thickness losses of the abdominal wall. Ann Surg 193:612–618

    Article  PubMed  CAS  Google Scholar 

  16. Schneider R, Herrington JL, Granda AM (1979) Marlex mesh in repair of a diaphramatic defect later eroding into the distal esophagus and stomach. Am Surg 45:337–339

    PubMed  CAS  Google Scholar 

  17. Voyles CR, Richardson JD, Bland KI (1981) Emergency abdominal wall reconstruction with polypropylene mesh. Short-term benefits versus long-term complications. Ann Surg 194:219–223

    Article  PubMed  CAS  Google Scholar 

  18. Helton WS, Fisichella PM, Berger R, Horgan S, Espat NJ, Abcarian H (2005) Short-term outcomes with small intestinal submucosa for ventral abdominal hernia. Arch Surg 140:549–562

    Article  PubMed  Google Scholar 

  19. Smart N, Immanuel A, Mercer-Jones M (2007) Laparoscopic repair of a Littre’s hernia with porcine dermal collagen implant (Permacol). Hernia 11:373–376

    Article  PubMed  CAS  Google Scholar 

  20. Inan I, Gervaz P, Hagen M, Morel P (2007) Laparoscopic repair of parastomal hernia using a porcine dermal collagen (Permacol) implant. Dis Colon Rectum 50:1465

    Article  PubMed  Google Scholar 

  21. Adedeji OA, Bailey CA, Varma JS (2002) Porcine dermal collagen graft in abdominal-wall reconstruction. Br J Plast Surg 55:85–86

    Article  PubMed  CAS  Google Scholar 

  22. Liyanage SH, Purohit GS, Frye JN, Giordano P (2006) Anterior abdominal wall reconstruction with a Permacol implant. J Plast Reconstr Aesthetic Surg 59:553–555

    Article  CAS  Google Scholar 

  23. MacLeod TM, Williams G, Sanders R, Green CJ (2003) Prefabricated skin flaps in a rat model based on a dermal replacement matrix Permacol. Br J Plast Surg 56:775–783

    Article  PubMed  CAS  Google Scholar 

  24. MacLeod TM, Sarathchandra P, Williams G, Sanders R, Green CJ (2004) Evaluation of a porcine origin acellular dermal matrix and small intestinal submucosa as dermal replacements in preventing secondary skin graft contraction. Burns 30:431–437

    Article  PubMed  CAS  Google Scholar 

  25. Macleod TM, Williams G, Sanders R, Green CJ (2005) Histological evaluation of Permacol as a subcutaneous implant over a 20-week period in the rat model. Br J Plast Surg 58:518–532

    Article  PubMed  CAS  Google Scholar 

  26. Kaleya RN (2005) Evaluation of implant/host tissue interactions following intraperitoneal implantation of porcine dermal collagen prosthesis in the rat. Hernia 9:269–276

    Article  PubMed  Google Scholar 

  27. Zheng F, Lin Y, Verbeken E, Claerhout F, Fastrez M, De Ridder D, Deprest J (2004) Host response after reconstruction of abdominal wall defects with porcine dermal collagen in a rat model. Am J Obstet Gynecol 191:1961–1970

    Article  PubMed  CAS  Google Scholar 

  28. Hammond TM, Chin-Aleong J, Navsaria H, Williams NS (2008) Human in vivo cellular response to a cross-linked acellular collagen implant. Br J Surg 95:438–446

    Article  PubMed  CAS  Google Scholar 

  29. Jansen PL, Mertens PR, Klinge U, Schumpelick V (2004). The biology of hernia formation. Surgery 136:1–4

    Article  PubMed  Google Scholar 

  30. Jarman-Smith ML, Bodamyali T, Stevens C, Howell JA, Horrocks M, Chaudhuri JB (2004) Porcine collagen crosslinking, degradation and its capability for fibroblast adhesion and proliferation. J Mater Sci Mater Med 15:925–932

    Article  PubMed  CAS  Google Scholar 

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Authors and Affiliations

  1. Centre for Academic Surgery, Institute of Cellular and Molecular Science, The Royal London Hospital, Barts and The London NHS Trust, Queen Mary School of Medicine and Dentistry, University of London, London, UK

    T. M. Hammond, A. Huang, K. Prosser, J. N. Frye & N. S. Williams

  2. 64 Cedar Lawn Avenue, Barnet, Hertfordshire, EN5 2LN, UK

    T. M. Hammond

Authors
  1. T. M. Hammond
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  2. A. Huang
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  3. K. Prosser
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  4. J. N. Frye
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  5. N. S. Williams
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Corresponding author

Correspondence to T. M. Hammond.

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Declaration: The experiments performed comply with the current laws of the country in which they were performed.

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Hammond, T.M., Huang, A., Prosser, K. et al. Parastomal hernia prevention using a novel collagen implant: a randomised controlled phase 1 study. Hernia 12, 475–481 (2008). https://doi.org/10.1007/s10029-008-0383-z

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  • DOI: https://doi.org/10.1007/s10029-008-0383-z

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