Abstract:
BACKGROUND AND STUDY AIMS:Secure transluminal closure remains a fundamental barrier to clinical introduction of natural orifice transluminal endoscopic surgery (NOTES). Current NOTES closure modalities either do not provide secure closure or are too challenging to apply in vivo. The aims of this study were to evaluate gastric closure using the over-the-scope clip (OTSC) system in a previously described experimental setup, comparing the acute strength with a gold standard (hand surgical suturing). METHODS:Comparison was done using an ex vivo porcine stomach experimental setup. The gastric opening was created by a needle knife puncture followed by dilation with 18-mm balloon. Control gastrotomies (n = 15; surgical suturing) showed a mean leak pressure of 206 mmHg (SD 59). A noninferiority design required a sample size of 11 specimens for the OTSC group. Closure comprised: (i) approximation of muscular layers using a flexible twin grasper; (ii) pulling the tissue into the OTSC cap at the tip of the scope; (iii) releasing the clip. Main outcome measures were leak pressure of closed gastrotomies, leak location, and time needed for adequate closure. RESULTS:Closure was successful in all specimens in a median of 3 minutes. Closed gastrotomies showed air leakage at mean pressure of 233 mmHg (SD 47), which was non-inferior compared with the predetermined gold standard (P = 0.003). CONCLUSIONS:Closure of gastric incisions to meet a predetermined leak pressure criterion was attainable and easy with the OTSC system. In vivo survival animal experiments are needed to further evaluate this promising closure modality.
journal_name
Endoscopyjournal_title
Endoscopyauthors
Voermans RP,van Berge Henegouwen MI,Bemelman WA,Fockens Pdoi
10.1055/s-0029-1215231subject
Has Abstractpub_date
2009-12-01 00:00:00pages
1052-5issue
12eissn
0013-726Xissn
1438-8812journal_volume
41pub_type
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