| Leaks and endoscopic assessment of break of integrity after NOTES gastrotomy: the LEAKING study, a prospective, randomized, controlled trial. | |
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MedLine Citation:
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PMID: 20185125 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Gastric leak testing after natural orifice transluminal endoscopic surgery (NOTES) gastrotomy closure may help reduce the risk of leaks after transgastric procedures. OBJECTIVE: To develop a novel endoscopy-based system to determine the presence of a leak after NOTES gastrotomy and to compare this system prospectively with radiographic leak testing. DESIGN: Prospective, randomized, controlled trial. SETTING: Academic Medical Center laboratory. SUBJECTS: Fifty swine. INTERVENTION: During the pretrial phase, an endoscopic system for the measurement of intragastric pressure was developed. In the trial phase, swine with a NOTES gastrotomy were randomized to endoscopic versus radiographic leak testing. If a leak was demonstrated, the gastrotomy was reclosed by using a second-generation prototype T-anchor system. The primary outcome was leak detection after gastrotomy closure. The secondary outcome variables included necropsy findings, peritoneal fluid analysis, histologic examination, and clinical outcome. RESULTS: Fourteen swine were included in the pretrial phase and 36 in the randomized trial. Swine were survived for a mean of 9 days postoperatively. Endoscopic pressure monitoring demonstrated a reproducible change in intragastric pressure with insufflation; r = 0.735, P = .001 and r = 0.769, P < or = .000 for the total and maximum pressures, respectively. Post-peritoneoscopy, there was a detectable and significant decrease in the mean total and mean maximum pressures versus baseline (P = .006 and P = .009). There was no significant difference between the radiologic and endoscopic arms in leak detection rate (4/18 vs 3/18, respectively, P = .500). Clinical outcomes and mean weight gain were equivalent. There was 1 operative abdominal wall injury and no deaths. LIMITATIONS: Animal study. CONCLUSION: Endoscopic pressure monitoring was reproducible, demonstrated the presence of gastric leak, and was as reliable as contrast-based radiographic leak testing. |
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Authors:
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Field F Willingham; Brian G Turner; Denise W Gee; Sevdenur Cizginer; Dae K Sohn; Patricia Sylla; Avinash Kambadakone; Dushyant Sahani; Mari Mino-Kenudson; David W Rattner; William R Brugge |
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Publication Detail:
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Type: Comparative Study; Evaluation Studies; Journal Article; Research Support, Non-U.S. Gov't Date: 2010-02-24 |
Journal Detail:
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Title: Gastrointestinal endoscopy Volume: 71 ISSN: 1097-6779 ISO Abbreviation: Gastrointest. Endosc. Publication Date: 2010 May |
Date Detail:
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Created Date: 2010-05-04 Completed Date: 2010-07-21 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0010505 Medline TA: Gastrointest Endosc Country: United States |
Other Details:
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Languages: eng Pagination: 1018-24 Citation Subset: IM |
Copyright Information:
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2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved. |
Affiliation:
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Department of Medicine, Gastrointestinal Unit, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts 02114, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Animals Contrast Media / diagnostic use Disease Models, Animal Gastroscopy Gastrostomy / adverse effects*, methods Postoperative Complications / diagnosis, radiography, therapy Pressure Swine |
| Chemical | |
Reg. No./Substance:
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0/Contrast Media |
| Comments/Corrections | |
Comment In:
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Gastrointest Endosc. 2010 May;71(6):1025-7
[PMID:
20438887
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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