title: 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.
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.
  
  
  OBJECTIVE
  The aim is to compare a submucosal tunnel access plus over-the-scope clip (OTSC) system for closure with two other closure modalities.
  
  
  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.
  
  
  CONCLUSIONS
  The combination of a submucosal tunnel access and OTSC offers a stronger closure than the other methods studied.
authors.affiliation: Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Gonzalez
authors.affiliation: Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
authors.forename: Kayoko
authors.initials: K
authors.lastname: Saito
authors.affiliation: Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
authors.forename: Changdon
authors.initials: C
authors.lastname: Kang
authors.affiliation: Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Gromski
authors.affiliation: Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
authors.forename: Mandeep
authors.initials: M
authors.lastname: Sawhney
authors.affiliation: Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
authors.forename: Ram
authors.initials: R
authors.lastname: Chuttani
authors.affiliation: Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA ; Department of Anesthesiology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Kai
authors.initials: K
authors.lastname: Matthes