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Aminian A, Khorgami Z. Hem-o-Lok Clip Is Safe in Minimally Invasive General Surgery: A Single Center Experience and Review of Data From Food and Drug Administration. ABS 2012; 1 (2)
URL: http://annbsurg.iums.ac.ir/article-1-247-fa.html
Hem-o-Lok Clip Is Safe in Minimally Invasive General Surgery: A Single Center Experience and Review of Data From Food and Drug Administration. سالنامه جراحی چاقی. 1 (2)

URL: http://annbsurg.iums.ac.ir/article-1-247-fa.html


چکیده:   (680 مشاهده)
Background: There are several methods for the ligation of structures during minimally invasive
operations. The hem-o-lok clip is a nonabsorbable polymer clip with a lock engagement
feature. There are few reports about its use in minimally invasive general surgical procedures.
Objectives: In this report, we describe our experience with the hem-o-lok clip during basic,
minimally invasive, general surgery procedures and the adverse events during application
of the hem-o-lok.
Patients and Methods: We retrospectively reviewed all laparoscopic appendectomies (LAs),
cholecystectomies (LCs), and splenectomies (LSs), performed by 6 general surgeons at a
university-affiliated hospital over 4 years. Clip failure was defined as intraoperative or postoperative
bleeding due to clip malfunction that necessitated placement of another clip, conversion
to an open procedure, or postoperative re-exploration. Leakage from the cystic duct
and appendiceal stump was also considered clip failure. A search of the US Food and Drug
Administration Manufacturer and User Facility Device Experience (MAUDE) database using
the appropriate keywords was performed on July 7, 2011. This online resource contains reports
of adverse events involving medical devices.
Results: Over a 4-year period, 856 laparoscopic operations, comprising 770 LC, 55 LS, and 31
LA, were performed. We did not observe any incidence of clip failure. There were 22 reports of
hem-o-lok clip failure in the MAUDA database. Eighty-two percent (n = 18) of clip failures were
reported during laparoscopic nephrectomy. There was no report of failure after LA. There
were 2 reported clip failures after LC (with bile leakage) and 1 after LS (tearing of splenic vessels
with intraoperative bleeding). There was also a report of migration of the hem-o-lok clip
into the common bile duct, which occurred 4 years after a complicated LC.
Conclusions: Hem-o-lok clips that are properly applied during basic laparoscopic procedures
are a secure option for the ligation of the structures. Surgeons must be educated regarding
the proper application technique.
     
نوع مطالعه: Original | موضوع مقاله: MIS
دریافت: 1399/10/4 | پذیرش: 1391/8/25 | انتشار الکترونیک: 1391/8/25

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