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A novel flexible endoluminal stapling device for use in NOTES colotomy closure: a feasibility study using an ex vivo porcine model

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Abstract

Background

With advances in endoscopic diagnosis of early-stage gastrointestinal pathology, the need to offer minimally invasive treatment is attracting significant interest. It is essential that secure and consistent closure of full-thickness colonic resections and colotomy access be provided in natural orifice translumenal surgery (NOTES). This ex vivo porcine study aimed to evaluate a novel prototype flexible endoscopic stapler device for use in closure of full-thickness colonic defects.

Methods

A feasibility study using ex vivo porcine colon was undertaken to explore the potential of the prototype stapler to close and seal a colotomy. A standardized linear colotomy was created in 30 colons. The novel flexible endostapler was used to close 20, interrupted hand-sewn sutures to close 5, and a well-validated linear stapler to close 5 of these colotomies. The colons were subsequently subjected to leak pressure testing.

Results

The colotomy closure using the prototype stapler endoluminally required a median time of 280 s. No statistically significant difference in leak pressures between the stapler and the other techniques was described. Although the endostapler without any colotomy was found to have the highest median leak pressures and the interrupted sutures the lowest pressures, no significant difference could be demonstrated (p = 0.52). Furthermore, no significant difference was demonstrated when the closure integrity created by the flexible stapler was compared with that created by the well-validated linear stapler.

Conclusion

The results suggest that the flexible endoscopic stapler is an effective device for the safe closure of a visceral defect, which in this feasibility study was equivalent to other well-established techniques. Further studies will focus on in vivo application of the prototype stapling device in the setting of full-thickness colonic resection.

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Disclosures

John Beardsley, Ted Bryant, and Kenneth Horton are employees of Covidien and were involved in the development of this prototype device. No specific financial support nor financial incentive was allocated to this study or persons involved by Covidien. Mikael Sodergren, James Clark, Ara Darzi, and Julian Teare have no conflicts of interest or financial ties to disclose.

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Authors and Affiliations

  1. Department of Biosurgery and Surgical Technology, Academic Surgical Unit, St. Mary’s Hospital, Imperial College London, 10th Floor QEQM, South Wharf Road, London, W2 1NY, UK

    Mikael Sodergren, James Clark, Ara Darzi & Julian Teare

  2. Research and Development Department, Covidien, North Haven, CT, USA

    John Beardsley, Ted Bryant & Kenneth Horton

Authors
  1. Mikael Sodergren
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  2. James Clark
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  3. John Beardsley
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  4. Ted Bryant
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  5. Kenneth Horton
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  6. Ara Darzi
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  7. Julian Teare
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Corresponding author

Correspondence to Mikael Sodergren.

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Sodergren, M., Clark, J., Beardsley, J. et al. A novel flexible endoluminal stapling device for use in NOTES colotomy closure: a feasibility study using an ex vivo porcine model. Surg Endosc 25, 3266–3272 (2011). https://doi.org/10.1007/s00464-011-1703-4

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  • DOI: https://doi.org/10.1007/s00464-011-1703-4

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