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Endoscopy 2008; 40(7): 595-601
DOI: 10.1055/s-2008-1077409
Original article

© Georg Thieme Verlag KG Stuttgart · New York

In vitro comparison and evaluation of seven gastric closure modalities for natural orifice transluminal endoscopic surgery (NOTES)

R.  P.  Voermans1 , 2 , A.  M.  Worm3 , M.  I.  van Berge Henegouwen2 , P.  Breedveld3 , W.  A.  Bemelman2 , P.  Fockens1
  • 1Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
  • 2Department of Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
  • 3Department of Biomechanical Engineering, University of Technology, Delft, The Netherlands
Weitere Informationen

Publikationsverlauf

submitted 06 June 2008

accepted after revision 10 June 2008

Publikationsdatum:
08. Juli 2008 (online)

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Siehe auch:

Commentaire de travail de R. P. Voermans et al., pp. 595Endoscopy 2008; 40(07): 710-710
DOI: 10.1055/s-0032-1306855

Background and study aims: Secure transluminal closure is the most fundamental prerequisite for the safe introduction of natural orifice transluminal endoscopic surgery (NOTES). The aim was to compare acute strength of various gastrotomy closure techniques in an in vitro porcine stomach model by assessing leak pressures.

Methods: Standardized gastrotomies were closed manually, without the use of an endoscope, by one of seven NOTES closure devices: (i) T tags, (ii) purse string modified T tags, (iii) Eagle Claw VIII, (iv) Resolution clips, (v) flexible stapler; (vi) purse string suturing device, and (vii) flexible Endostitch. After closure, each specimen was fixed on the experimental apparatus and the pressure was gradually increased. By linking the pressure gauge and two cameras, the leak location and pressure could be determined in detail. We began by collecting gold standard reference values, by testing 15 gastrotomies closed with interrupted surgical sutures; these were associated with a mean leak pressure of 206 mmHg (SD 59). Using a noninferiority design, a sample size of 11 specimens for each NOTES closure technique was determined.

Results: The Resolution clips (P = 0.0285), Eagle Claw VIII (P = 0.0325), flexible stapler (P < 0.001) and flexible Endostitch (P = 0.002) produced noninferior closures in comparison with the predetermined gold standard; T tags (P > 0.6775), purse string modified T tags (P > 0.999), and the purse string suturing device (P = 0.9875) resulted in inferior closures.

Conclusions: The Eagle Claw VIII, Resolution clips, flexible stapler and flexible Endostitch produced noninferior closures in comparison with surgical closure in this model. These techniques seem to be the prime candidates for further testing in animal experiments before human trials can be initiated.

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P. Fockens, MD, PhD 

Department of Gastroenterology and Hepatology, C2 – 325
Academic Medical Center

Meibergdreef 9
1105 AZ Amsterdam
The Netherlands

Fax: +31-20-6917033

eMail: p.fockens@amc.nl