Subscribe to RSS
![](/products/assets/desktop/img/oa-logo.png)
DOI: 10.1055/s-0034-1390794
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
Publication History
submitted 21 July 2014
accepted after revision 26 August 2014
Publication Date:
12 November 2014 (online)
![](https://www.thieme-connect.de/media/10.1055-s-00025476/201501/lookinside/thumbnails/10.1055-s-0034-1390794-1.jpg)
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.
-
References
- 1 Kalloo AN, Singh VK, Jagannath SB et al. Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic interventions in the peritoneal cavity. Gastrointest Endosc 2004; 60: 114-117
- 2 Von Renteln D, Vassiliou MC, Rothstein RI. Randomized controlled trial comparing endoscopic clips and over-the-scope clips for closure of natural orifice transluminal endoscopic surgery gastrotomies. Endoscopy 2009; 41: 1056-1061
- 3 Wagh MS, Merrifield BF, Thompson CC. Survival studies after endoscopic transgastric oophorectomy and tubectomy in a porcine model. Gastrointest Endosc 2006; 63: 473-478
- 4 Desilets DJ, Romanelli JR, Earle DB et al. Loop-anchor purse-string versus endoscopic clips for gastric closure: a natural orifice transluminal endoscopic surgery comparison study using burst pressures. Gastrointest Endosc 2009; 70: 1225-1230
- 5 Sumiyama K, Gostout CJ, Rajan E et al. Endoscopic full-thickness closure of large gastric perforations by use of tissue anchors. Gastrointest Endosc 2007; 65: 134-139
- 6 Ikeda K, Fritscher-Ravens A, Mosse CA et al. Endoscopic full-thickness resection with sutured closure in a porcine model. Gastrointest Endosc 2005; 62: 122-129
- 7 Voermans RP, Worm AM, van Berge Henegouwen MI et al. In vitro comparison and evaluation of seven gastric closure modalities for natural orifice transluminal endoscopic surgery (NOTES). Endoscopy 2008; 40: 595-601
- 8 Pham BV, Raju GS, Ahmed I et al. Immediate endoscopic closure of colon perforation by using a prototype endoscopic suturing device: feasibility and outcome in a porcine model (with video). Gastrointest Endosc 2006; 64: 113-119
- 9 Ryou M, Fong DG, Pai RD et al. Transluminal closure for NOTES : an ex vivo study comparing leak pressures of various gastrotomy and colotomy closure modalities. Endoscopy 2008; 40: 432-436
- 10 Romanelli JR, Desilets DJ, Chapman CN et al. Loop-anchor purse-string closure of gastrotomy in NOTES(R) procedures: survival studies in a porcine model. Surg Innov 2010; 17: 312-317
- 11 McGee MF, Marks JM, Onders RP et al. Complete endoscopic closure of gastrotomy after natural orifice translumenal endoscopic surgery using the NDO plicator. Surg Endosc 2008; 22: 214-220
- 12 McGee MF, Marks JM, Jin J et al. Complete endoscopic closure of gastric defects using a full-thickness tissue plicating device. J Gastrointest Surg 2008; 12: 38-45
- 13 Martínek J, Ryska O, Tuckova I et al. Comparing over-the-scope clip versus endoloop and clips (KING closure) for access site closure: a randomized experimental study. Surg Endosc 2013; 27: 1203-1210
- 14 Sumiyama K, Gostout CJ, Rajan E et al. Submucosal endoscopy with mucosal flap safety valve. Gastrointest Endosc 2007; 65: 688-694
- 15 Moyer MT, Pauli EM, Haluck RS et al. A self-approximating transluminal access technique for potential use in NOTES: an ex vivo porcine model (with video). Gastrointest Endosc 2007; 66: 974-978
- 16 Pauli EM, Moyer MT, Haluck RS et al. Self-approximating transluminal access technique for natural orifice transluminal endoscopic surgery: a porcine survival study (with video). Gastrointest Endosc 2008; 67: 690-697
- 17 Mathew A, Tomasko JM, Pauli EM et al. Reliability of gastric access closure with the self-approximating transluminal access technique (STAT) for NOTES. Surg Endosc 2011; 25: 2718-2724
- 18 Yoshizumi F, Yasuda K, Kawaguchi K et al. Submucosal tunneling using endoscopic submucosal dissection for peritoneal access and closure in natural orifice transluminal endoscopic surgery: a porcine survival study. Endoscopy 2009; 41: 707-711
- 19 Voermans RP, Le Moine O, von Renteln D et al. Efficacy of endoscopic closure of acute perforations of the gastrointestinal tract. Clin Gastroenterol Hepatol 2012; 10: 603-608
- 20 Kirschniak A, Subotova N, Zieker D et al. The over-the-scope clip (OTSC) for the treatment of gastrointestinal bleeding, perforations, and fistulas. Surg Endosc 2011; 25: 2901-2905
- 21 Von Delius S, Gillen S, Doundoulakis E et al. Comparison of transgastric access techniques for natural orifice transluminal endoscopic surgery. Gastrointest Endosc 2008; 68: 940-947
- 22 Matthes K, Jung Y, Kato M et al. Efficacy of full-thickness GI perforation closure with a novel over-the-scope clip application device: an animal study. Gastrointest Endosc 2011; 74: 1369-1375
- 23 Azadani A, Bergström M, Dot J et al. A new in vivo method for testing closures of gastric NOTES incisions using leak of the closure or gastric yield as endpoints. J Laparoendosc Adv Surg Tech Part A 2012; 22: 46-50
- 24 El-Serag HB, Tran T, Richardson P et al. Anthropometric correlates of intragastric pressure. Scand J Gastroenterol 2006; 41: 887-891
- 25 Iqbal A, Haider M, Stadlhuber RJ et al. A study of intragastric and intravesicular pressure changes during rest, coughing, weight lifting, retching, and vomiting. Surg Endosc 2008; 22: 2571-2575