Natural orifice transluminal endoscopic surgery gastrotomy closure with an over-the-endoscope clip: a randomized, controlled porcine study (with videos)
Received 13 January 2009; accepted 5 March 2009. published online 26 June 2009.
Background
Secure endoscopic closure of transgastric natural orifice transluminal endoscopic surgery (NOTES) access is of paramount importance. The over-the-scope clip (OTSC) system has previously been shown to be effective for NOTES gastrotomy closure.
Objective
To compare OTSC gastrotomy closure with surgical closure.
Design
Randomized, controlled animal study.
Setting
Animal facility laboratory.
Animals
Thirty-six female domestic pigs.
Interventions
Gastrotomies were created by using a needle-knife and an 18-mm balloon. The animals were subsequently randomized to either open surgical repair with interrupted sutures or endoscopic repair with 12-mm OTSCs. In addition, pressurized leak tests were performed in ex vivo specimens of 18-mm scalpel incisions closed with suture (n = 14) and of intact stomachs (n = 10).
Main Outcome Measurements
The mean time for endoscopic closure was 9.8 minutes (range 3-22, SD 5.5). No complications occurred during either type of gastrotomy closure. At necropsy, examination of all OTSC and surgical closures demonstrated complete sealing of gastrotomy sites without evidence of injury to adjacent organs. Pressurized leak tests showed a mean burst pressure of 83 mm Hg (range 30-140, SD 27) for OTSC closures and 67 mm Hg (range 30-130, SD 27.7) for surgical sutures. Ex vivo hand-sewn sutures of 18-mm gastrotomies (n = 14) exhibited a mean burst pressure of 65 mm Hg (range 20-140, SD 31) and intact ex vivo stomachs (n = 10) had a mean burst pressure of 126 mm Hg (range 90-170, SD 28). The burst pressure of ex vivo intact stomachs was significantly higher compared with OTSC closures (P < .01), in vivo surgical closures (P < .01), and ex vivo hand-sewn closures (P < .01). There was a trend toward higher burst pressures in the OTSC closures compared with surgical closures (P = .063) and ex vivo hand-sewn closures (P = .094). In vivo surgical closures demonstrated similar burst pressures compared with ex vivo hand-sewn closures (P = .848).
Limitations
Nonsurvival setting.
Conclusion
Endoscopic closure by using the OTSC system is comparable to surgical closure in a nonsurvival porcine model. This technique is easy to perform and is suitable for NOTES gastrotomy closure.
Ludwigsburg, Heidelberg, Germany, Lebanon, New Hampshire, USA
Current affiliations: Department of Gastroenterology (D.v.R., A.S., K.C.), Medizinische Klinik I, Klinikum Ludwigsburg, Ludwigsburg, Germany, Department of Surgery (M.C.V.), Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA, University Hospital Mannheim (M.G.), University of Heidelberg, Germany
Reprint requests: Karel Caca, MD, Department of Gastroenterology, Hepatology, and Oncology, Klinikum Ludwigsburg, 71640 Ludwigsburg, Germany.
DISCLOSURE: Material support (endoscopic equipment, funding of the animal procedures and endotherapeutic material) for this study was provided directly to the animal facility by Ovesco AG, Tübingen, Germany, and Olympus Deutschland GmbH, Hamburg, Germany. All authors disclosed no financial relationships relevant to this publication.
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ABSTRACT
Natural orifice transluminal endoscopic surgery gastrotomy closure with an over-the-endoscope clip: a randomized, controlled porcine study (with videos)