Document Detail

Leaks and endoscopic assessment of break of integrity after NOTES gastrotomy: the LEAKING study, a prospective, randomized, controlled trial.
MedLine Citation:
PMID:  20185125     Owner:  NLM     Status:  MEDLINE    
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.
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:
Type:  Comparative Study; Evaluation Studies; Journal Article; Research Support, Non-U.S. Gov't     Date:  2010-02-24
Journal Detail:
Title:  Gastrointestinal endoscopy     Volume:  71     ISSN:  1097-6779     ISO Abbreviation:  Gastrointest. Endosc.     Publication Date:  2010 May 
Date Detail:
Created Date:  2010-05-04     Completed Date:  2010-07-21     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0010505     Medline TA:  Gastrointest Endosc     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1018-24     Citation Subset:  IM    
Copyright Information:
2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.
Department of Medicine, Gastrointestinal Unit, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts 02114, USA.
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MeSH Terms
Contrast Media / diagnostic use
Disease Models, Animal
Gastrostomy / adverse effects*,  methods
Postoperative Complications / diagnosis,  radiography,  therapy
Reg. No./Substance:
0/Contrast Media
Comment In:
Gastrointest Endosc. 2010 May;71(6):1025-7   [PMID:  20438887 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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