Endoscopy 2009; 41(12): 1056-1061
DOI: 10.1055/s-0029-1215241
Original article

© Georg Thieme Verlag KG Stuttgart · New York

Randomized controlled trial comparing endoscopic clips and over-the-scope clips for closure of natural orifice transluminal endoscopic surgery gastrotomies

D. von  Renteln1 , M.  C.  Vassiliou1 , 2 , R.  I.  Rothstein1
  • 1Department of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA
  • 2Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA
Further Information

Publication History

submitted 20 April 2009

accepted after revision 16 September 2009

Publication Date:
06 November 2009 (online)

Background and study aim: Secure and reliable endoscopic closure is of paramount importance before clinical introduction of transgastric natural orifice transluminal endoscopic surgery (NOTES). Gastrotomy closure in humans using standard endoclips has been reported. The aim of this study was to assess the safety of standard endoclip closure and to compare it to a new over-the-scope clip (OTSC) specifically designed for gastrotomy closure.

Material and methods: Gastric wall puncture and balloon dilation followed by peritoneoscopy was carried out in 20 female swine. After randomization, closure of the gastric incision was performed using a tissue approximation grasper and either endoclips or OTSCs.

Results: Mean (± SD) time for gastrotomy closure using endoclips was 31.5 ± 24.2 minutes (range 8 – 88 minutes) compared with 8.5 ± 9.1 minutes (range 2 – 31 minutes) using OTSC (P = 0.002). No intraoperative complications occurred. Laparoscopic leak tests with insufflation and saline immersion demonstrated three minor leaks and one major leak in the endoclip closures. No leaks were observed in the OTSC group. At necropsy, complete sealing of the gastrotomy sites was found in all OTSC closures. Small, localized perigastric abscesses were observed in two animals in the OTSC group and in three animals in the endoclip group. One animal in the endoclip group was sacrificed prematurely due to signs of sepsis and was found to have gross peritonitis secondary to a leak. At necropsy, evidence of peritonitis was identified in two other animals in the endoclip group.

Conclusion: NOTES gastrotomy closure using standard endoclips, even with a tissue approximation grasper, is associated with an increased risk of leakage and intra-abdominal infection compared with OTSC. The significance of perigastric abscesses, which were seen in both groups, warrants further investigation.

References

  • 1 Kalloo A N, Singh V K, Jagannath S B. et al . Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic interventions.  Gastrointest Endosc. 2004;  60 114-117
  • 2 Rao G V, Reddy D N, Banerjee R. NOTES: human experience.  Gastrointest Endosc Clin N Am. 2008;  18 361-370
  • 3 Marks J M, Ponsky J L, Pearl J P, McGee M. PEG “rescue”: a practical NOTES technique.  Surg Endosc. 2007;  21 816-819
  • 4 Marescaux J, Dallemagne B, Perretta S. et al . Surgery without scars: report of transluminal cholecystectomy in a human being.  Arch Surg. 2007;  142 823-826
  • 5 Shih S P, Kantsevoy S V, Kalloo A N. et al . Hybrid minimally invasive surgery: a bridge between laparoscopic and translumenal Surgery.  Surg Endosc. 2007;  21 1450-1453
  • 6 Branco Filho A J, Noda R W, Kondo W. et al . Initial experience with hybrid transvaginal cholecystectomy.  Gastrointest Endosc. 2007;  66 1245-1248
  • 7 Bessler M, Stevens P D, Milone L. et al . Transvaginal laparoscopically assisted endoscopic cholecystectomy: a hybrid approach to natural orifice surgery.  Gastrointest Endosc. 2007;  66 1243-1245
  • 8 Zornig C, Emmermann A, von Waldenfels H A. et al . Laparoscopic cholecystectomy without visible scar: combined transvaginal and transumbilical approach.  Endoscopy. 2007;  39 913-915
  • 9 Zornig C, Mofid H, Emmermann A. et al . Scarless cholecystectomy with combined transvaginal and transumbilical approach in a series of 20 patients.  Surg Endosc. 2008;  22 1427-1429
  • 10 Ryou M, Pai R D, Pai R. et al . Evaluating an optimal gastric closure method for transgastric surgery.  Surg Endosc. 2007;  21 677-680
  • 11 Ryou M, Fong D G, Pai R D. et al . Evaluation of a novel access and closure device for NOTES applications: a transcolonic survival study in the porcine model.  Gastrointest Endosc. 2008;  67 964-969
  • 12 Magno P, Giday S A, Dray X. et al . A new stapler-based full-thickness transgastric access closure: results from an animal pilot trial.  Endoscopy. 2007;  39 876-880
  • 13 Ryou M, Fong D G, Pai R D. et al . Dual-port distal pancreatectomy using a prototype endoscope and endoscopic stapler: a natural orifice transluminal endoscopic surgery (NOTES) survival study in a porcine model.  Endoscopy. 2007;  39 881-887
  • 14 Moyer M T, Pauli E M, Haluck R S, Mathew A. A self-approximating transluminal access technique for potential use in NOTES: an ex vivo porcine model (with video).  Gastrointest Endosc. 2007;  66 974-978
  • 15 Pauli E M, Moyer M T, Haluck R S, Mathew A. Self-approximating transluminal access technique for natural orifice transluminal endoscopic surgery: a porcine survival study.  Gastrointest Endosc. 2008;  67 690-697
  • 16 Voermans R P, Worm A M, van Berge Henegouwen M I. et al . In vitro comparison and evaluation of seven gastric closure modalities for natural orifice transluminal endoscopic surgery (NOTES).  Endoscopy. 2008;  40 595-601
  • 17 Von Renteln D, Kaehler G, Eickhoff A. et al . Gastric full-thickness suturing following NOTES procedures for closure of the access site to the peritoneal cavity.  Endoscopy. 2008;  40 E99-E100
  • 18 McGee M F, Marks J M, Jin J. et al . Complete endoscopic closure of gastric defects using a full-thickness tissue plicating device.  J Gastrointest Surg. 2008;  12 38-45
  • 19 Ryou M, Fong D G, Pai R D. 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
  • 20 McGee M F, Marks J M, Onders R P. et al . Complete endoscopic closure of gastrotomy after natural orifice translumenal endoscopic surgery using the NDO Plicator.  Surg Endosc. 2008;  22 214-220
  • 21 Von Renteln D, Eickhoff A, Kaehler G. et al . Endoscopic closure of the natural orifice transluminal endoscopic surgery (NOTES) access site to the peritoneal cavity by means of transmural resorbable sutures: an animal survival study.  Endoscopy. 2009;  41 154-159
  • 22 Kratt T, Küper M, Traub F. et al . Feasibility study for secure closure of natural orifice transluminal endoscopic surgery gastrotomies by using over-the-scope clips.  Gastrointest Endoscopy. 2008;  68 993-996
  • 23 Merrifield B F, Wagh M S, Thompson C C. Peroral transgastric organ resection: a feasibility study in pigs.  Gastrointest Endosc. 2006;  63 693-697
  • 24 Pai R D, Fong D G, Bundga M E. et al . Transcolonic endoscopic cholecystectomy: a NOTES survival study in a porcine model (with video).  Gastrointest Endosc. 2006;  64 428-434
  • 25 Rattner D, Kalloo A. ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery.  Surg Endosc. 2006;  20 329-333
  • 26 Hawes R H, Rattner D W, Fleischer D. et al . NOTES: where have we been and where are we going?.  Gastrointest Endosc. 2008;  67 779-780
  • 27 Rao G V, Reddy D N, Banerjee R. NOTES: human experience.  Gastrointest Endosc Clin N Am. 2008;  18 361-370
  • 28 Rao G V, Reddy D N. Transgastric peritoneoscopy in a patient. Live transmission and demonstration presented at Endoclub Nord 2007, Hamburg, Germany. 
  • 29 Schurr M O, Arrezzo A, Ho C N. et al . The OTSC clip for endoscopic organ closure in NOTES: device and technique.  Minim Invasive Ther Allied Technol. 2008;  17 262-266
  • 30 Von Renteln D, Schmidt A, Vassiliou M C. et al . Natural orifice transluminal endoscopic surgery gastrotomy closure using an over-the-endoscope clip: a randomized controlled porcine study (with videos).  Gastrointest Endosc. 2009;  70 732-739
  • 31 Beard J D, Nicholson M L, Sayers R D. et al . Intraoperative air testing of colorectal anastomoses: a prospective, randomized trial.  Br J Surg. 1990;  77 1095-1097
  • 32 Shin R B. Intraoperative endoscopic test resulting in no postoperative leaks from the gastric pouch and gastrojejunal anastomosis in 366 laparoscopic Roux-en-Y gastric bypasses.  Obes Surg. 2004;  14 1067-1069
  • 33 Sekhar N, Torquati A, Lutfi R. et al . Endoscopic evaluation of the gastrojejunostomy in laparoscopic gastric bypass. A series of 340 patients without postoperative leak.  Surg Endosc. 2006;  20 199-201
  • 34 Schmidt O, Merkel S, Hohenberger W. Anastomotic leakage after low rectal stapler anastomosis: significance of intraoperative anastomotic testing.  Eur J Surg Oncol. 2003;  29 239-243
  • 35 Kligman M D. Intraoperative endoscopic pneumatic testing for gastrojejunal anastomotic integrity during laparoscopic Roux-en-Y gastric bypass.  Surg Endosc. 2007;  21 1403-1405
  • 36 Dray X, Gabrielson K L, Buscaglia J M. et al . Air and fluid leak tests after NOTES procedures: a pilot study in a live porcine model.  Gastrointest Endosc. 2008;  68 513-519
  • 37 Dray X, Redding S K, Shin E J. et al . Hydrogen leak test is minimally invasive and highly specific for assessment of the integrity of the luminal closure after natural orifice transluminal endoscopic surgery procedures (with video).  Gastrointest Endosc. 2009;  69 554-560
  • 38 Schurr M O, Hartmann C, Ho C N. et al . An over-the-scope clip (OTSC) system for closure of iatrogenic colon perforations: results of an experimental survival study in pigs.  Endoscopy. 2008;  40 584-588

R. I. RothsteinMD 

Section of Gastroenterology and Hepatology
Dartmouth-Hitchcock Medical Center

1 Medical Center Drive
Lebanon
NH 03756
USA

Fax: +1-603-650-5225

Email: richard.rothstein@dartmouth.edu

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