Prospective randomized comparison of gastrotomy closure associating tunnel access and over-the-scope clip (OTSC) with two other methods in an experimental ex vivo setting
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Gromski, Mark
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https://doi.org/10.1055/s-0034-1390794Metadata
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Gonzalez, Jean-Michel, Kayoko Saito, Changdon Kang, Mark Gromski, Mandeep Sawhney, Ram Chuttani, and Kai Matthes. 2015. “Prospective randomized comparison of gastrotomy closure associating tunnel access and over-the-scope clip (OTSC) with two other methods in an experimental ex vivo setting.” Endoscopy International Open 3 (1): E83-E89. doi:10.1055/s-0034-1390794. http://dx.doi.org/10.1055/s-0034-1390794.Abstract
Background: Safe transgastric natural orifice transluminal endoscopic surgery (NOTES) procedures require a reliable closure of the gastrotomy. Recently a novel peritoneal access method via a submucosal tunnel has been described with encouraging preliminary results. Aim: The aim is to compare a submucosal tunnel access plus over-the-scope clip (OTSC) system for closure with two other closure modalities. Patients and methods: This is a prospective ex vivo study conducted on 42 porcine stomach models equally randomized into three groups in an academic medical center. The procedures performed in each group included: (1) Tunnel (6 cm) + endoclips; (2) Knife + balloon dilation access + OTSC; and (3) Tunnel + OTSC. A pressurized air-leak test was performed to evaluate the strength of the closure. Stomach volumes, procedure times, number of clips, and incision sizes were also registered. Results: The mean air-leak pressure was statistically higher in Group 3 than in Groups 1 and 2–95.2 ± 19.3 mmHg versus 72.5 ± 35.2 and 79.0 ± 24.5 mmHg (P < 0.05). The gastrotomy creation times for Groups 1, 2, and 3 were 28.0 ± 10.1, 4.3 ± 1.4, and 20.1 ± 10.6 minutes, respectively, with significantly lower time in Group 2 (P < 0.001). The closure times were 16.1 ± 6.1, 6.5 ± 1.2, and 5.3 ± 3.0 minutes, respectively, and significantly longer in the endoclip group (P < 0.001). There were no differences in the volumes and the incision sizes among the three groups. Conclusion: The combination of a submucosal tunnel access and OTSC offers a stronger closure than the other methods studied.Other Sources
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4423288/pdf/Terms of Use
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