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Efficacy of an Absorbable Fibrin Sealant Patch (TachoSil) After Distal Pancreatectomy: A Multicenter, Randomized, Controlled Trial.
MedLine Citation:
PMID:  23095631     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
OBJECTIVE:: To evaluate the role of an absorbable fibrin sealant patch (TachoSil) in reducing postoperative pancreatic fistula (POPF) after distal pancreatectomy (DP). BACKGROUND:: POPF remains the main complication after DP. METHODS:: This was a prospective, open, randomized, study in which patients undergoing elective DP were randomized to standard surgical suturing or stapling with or without TachoSil. The primary end point was the incidence of POPF according to International Study Group on Pancreatic Fistula criteria. Amylase level in drainage fluid, number of days until removal of drain, and duration of hospital stay were secondary end points. RESULTS:: A total of 275 patients were enrolled at 19 centers over a 2-year period (TachoSil, n = 145; standard, n = 130). Twenty percent of procedures were laparoscopic and 21% were spleen-preserving resections. The incidence of POPF was not significantly different between groups (TachoSil, 62%; standard 68%; P = 0.267). Grade A fistula rate was similar in both groups (TachoSil 54%; standard 55%), whereas the grade B + C fistula rate was 8% with TachoSil versus 14% without (P = 0.139). Amylase drainage level on postoperative day 1 was significantly reduced with TachoSil (P = 0.025). Median number of days until drainage removal and length of hospital stay were similar in both groups (7 and 10 days, respectively). CONCLUSIONS:: The POPF rate was higher than expected when International Study Group on Pancreatic Fistula criteria were strictly applied, although the majority were biochemical fistulas. TachoSil had no significant effect on the rate of POPF, although there was a significant reduction of amylase level in drainage fluid on postoperative day 1.
Authors:
Marco Montorsi; Alessandro Zerbi; Claudio Bassi; Lorenzo Capussotti; Roberto Coppola; Matteo Sacchi;
Publication Detail:
Type:  JOURNAL ARTICLE    
Journal Detail:
Title:  Annals of surgery     Volume:  256     ISSN:  1528-1140     ISO Abbreviation:  Ann. Surg.     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-10-25     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372354     Medline TA:  Ann Surg     Country:  -    
Other Details:
Languages:  ENG     Pagination:  853-860     Citation Subset:  -    
Affiliation:
*Department of General Surgery, University of Milan, Istituto Clinico Humanitas IRCCS, Milano, Italy †Department of Surgery, Università degli Studi di Verona, Policlinico G.B. Rossi, Verona, Italy ‡Department of Surgery, Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, Italy §Department of Surgery, Università Campus Biomedico, Roma, Italy ‖Clinical Investigators and Participating Centers List.
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