(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing record evaluation cannot be reviewed as the lot number has not been provided.Citation: it was reported via journal article: title: "bile leakage following laparoscopic cholecystectomy." authors: j.L.A.Albasini, v.S.Aledo, s.P.L.Dexter, j.Marton, i.G.Martin, m.J.Mcmahon citation: surg endosc (1995); 9:1274-1278.(b)(4).
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It was reported via journal article: title: "bile leakage following laparoscopic cholecystectomy." authors: j.L.A.Albasini, v.S.Aledo, s.P.L.Dexter, j.Marton, i.G.Martin, m.J.Mcmahon, citation: surg endosc (1995); 9: 1274-1278.Laparoscopic cholecystectomy (lc) is now the treatment of choice for gallstones, but there has been concern that bile leakage with lc is more frequent than after open cholecystectomy (oc).The authors analyzed their experience of this complication with regard to both its incidence and management.This study involves 500 patients (age range: 19-89 years) who underwent laparoscopic cholecystectomy between june 1990 and november 1994.The cystic duct was occluded with absolok absorbable polydioxanone locking clip (ethicon), endoloop chromic catgut (ethicon) and vicryl suture (ethicon).Reported complications included: patient 7 with sub phrenic collection, fever, right upper quadrant pain which was treated successfully by ultrasound-guided percutaneous drainage.In conclusion, the data support the view that bile leakage occurs more commonly after laparoscopic than after conventional cholecystectomy.The reason for the difference is unclear, as is the source of bile leakage in most patients.It is the author¿s contention that the increased frequency of bile leakage creates a greater priority for routine drainage of the subhepatic space after laparoscopic cholecystectomy.
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