TY - JOUR
T1 - Controlled trial of immediate endoluminal closure of colon perforations in a porcine model by use of a novel clip device (with videos){A figure is presented}
AU - Raju, Gottumukkala S.
AU - Ahmed, Ijaz
AU - Xiao, Shu Yuan
AU - Brining, Douglas
AU - Poussard, Allison
AU - Tarcin, Orhan
AU - Shibukawa, Goro
AU - Dawson, Kristin
AU - Knight, Gary
AU - Tanguay, Randall
AU - Hull, Joanne
N1 - Funding Information:
The authors have no financial or other interests in the manufacture or distribution of any device or drug mentioned in this article. The authors received no patents, equity holdings, or consulting fees. G.S.R. has received honoraria from Pentax Medical Company and InScope, a division of Ethicon Endo-Surgery, Inc, Cincinnati, Ohio, during the last one year, and serves as a consultant to the InScope, a division of Ethicon Endo-Surgery, Inc, Cincinnati, Ohio, for the tissue approximation device. Supported by Pentax Medical Company and InScope, a division of Ethicon Endo-Surgery, Inc, Cincinnati, Ohio.
Funding Information:
We thank Jay Pasricha for his passionate support of our endoscopic research endeavors. We thank the Pentax Medical Company, Montvale, NJ, for supporting the animal endoscopy laboratory with equipment and InScope, Ethicon Endo-Surgery, Inc, Cincinnati, Ohio, for funding this study. We thank our colleagues at the IACUC and ARC staff for their cooperation and generous support in helping us pursue endoscopic research. We thank Ron Kolota of InScope, a division of Ethicon Endo-Surgery, Inc, Cincinnati, Ohio, for his support in this experimental work.
PY - 2006/12
Y1 - 2006/12
N2 - Background: Although endoluminal closure of a small perforation of the colon is technically feasible, the outcome of such a closure is unclear. Objective: Our purpose was to evaluate the feasibility and the outcome of endoluminal closure of a small perforation of the colon with a novel clip device, the InScope MultiClip Applier (IMCA), and to assess the number of clips required for successful closure. Design: Prospective controlled study. Setting: University hospital. Animals: 17 pigs. Interventions: A 2-cm full-thickness colon perforation was randomized to 3 groups: control, no closure (n = 4), 2-clip closure (n = 7), and 4-clip closure (n = 6). Main Outcome Measurements: (1) Technical feasibility of closure, (2) closure time, (3) clinical monitoring for 2 weeks, (4) necropsy (day 14), and (5) healing by a dye leak test and histologic examination. Results: Endoscopic closure of the colon perforation was technically successful in 12 of 13 animals. A wide gaping hole prevented satisfactory closure in 1 animal. The median time for closure with 2 and 4 clips was 2 and 3 minutes, respectively. Clip closure of perforation prevented clinical sepsis (P = .008) and diminished the risk for fibrinous peritonitis (P = .02 for a single test of hypothesis; however, correction for the multiple testing of data removes this significance) and adhesion formation (P = .008) compared with controls, without any leakage. The outcomes of 2- and 4-clip closure were similar. Conclusions: Endoluminal closure of a 2-cm colon perforation with clips is successful in preventing peritonitis and adhesions and it can be accomplished quickly with this novel device. Clip closure at 1-cm intervals is sufficient for successful closure of a 2-cm colon perforation.
AB - Background: Although endoluminal closure of a small perforation of the colon is technically feasible, the outcome of such a closure is unclear. Objective: Our purpose was to evaluate the feasibility and the outcome of endoluminal closure of a small perforation of the colon with a novel clip device, the InScope MultiClip Applier (IMCA), and to assess the number of clips required for successful closure. Design: Prospective controlled study. Setting: University hospital. Animals: 17 pigs. Interventions: A 2-cm full-thickness colon perforation was randomized to 3 groups: control, no closure (n = 4), 2-clip closure (n = 7), and 4-clip closure (n = 6). Main Outcome Measurements: (1) Technical feasibility of closure, (2) closure time, (3) clinical monitoring for 2 weeks, (4) necropsy (day 14), and (5) healing by a dye leak test and histologic examination. Results: Endoscopic closure of the colon perforation was technically successful in 12 of 13 animals. A wide gaping hole prevented satisfactory closure in 1 animal. The median time for closure with 2 and 4 clips was 2 and 3 minutes, respectively. Clip closure of perforation prevented clinical sepsis (P = .008) and diminished the risk for fibrinous peritonitis (P = .02 for a single test of hypothesis; however, correction for the multiple testing of data removes this significance) and adhesion formation (P = .008) compared with controls, without any leakage. The outcomes of 2- and 4-clip closure were similar. Conclusions: Endoluminal closure of a 2-cm colon perforation with clips is successful in preventing peritonitis and adhesions and it can be accomplished quickly with this novel device. Clip closure at 1-cm intervals is sufficient for successful closure of a 2-cm colon perforation.
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U2 - 10.1016/j.gie.2006.06.058
DO - 10.1016/j.gie.2006.06.058
M3 - Article
C2 - 17140911
AN - SCOPUS:33751515398
SN - 0016-5107
VL - 64
SP - 989
EP - 997
JO - Gastrointestinal endoscopy
JF - Gastrointestinal endoscopy
IS - 6
ER -