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

摘要

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?