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J Laparoendosc Adv Surg Tech A · Dec 2014
Multicenter Study Comparative Study Clinical TrialUse of floseal hemostatic matrix for control of hemostasis during laparoscopic cholecystectomy for acute cholecystitis: a multicenter historical control group comparison (the GLA study gelatin matrix for acute cholecystitis).
- Massimo Sartelli, Fausto Catena, Alessia Biancafarina, Cristian Tranà, Andrea Piccardo, Graziano Ceccarelli, Giuseppe Tirone, Ferdinando Agresta, Andrea Di Giorgio, Marco Catani, Fausto Tricarico, Maurizio Buonanno, and Luigi Piazza.
- 1 Department of Surgery, Macerata Hospital , Macerata, Italy .
- J Laparoendosc Adv Surg Tech A. 2014 Dec 1;24(12):837-41.
BackgroundIn patients with acute cholecystitis undergoing laparoscopic cholecystectomy, bleeding is a common complication that can reduce procedural visibility and worsen outcome. Insufficient hemostasis can also lead to postoperative bleeding that can, in rare cases, be fatal. Topical hemostatic agents are used to ensure adequate hemostasis during laparoscopic cholecystectomy.Subjects And MethodsThis prospective, open-label, nonrandomized, historical control group study investigated the use of Floseal(®) (Baxter International, Inc., Deerfield, IL) hemostatic matrix as an adjunct to surgical techniques to achieve hemostasis of the resected areas in patients undergoing laparoscopic cholecystectomy for acute cholecystitis. The primary end point was the rate of complete hemostasis 10 minutes after laparoscopic application of Floseal to the gallbladder bed. Secondary end points included complete hemostasis rates at 2, 4, and 6 minutes, surgery time, laparoscopic procedure to open laparotomy conversion rate, postoperative bleeding rate, and mortality and safety outcomes over the entire follow-up period.ResultsFrom April to November 2011, 101 consecutive patients were enrolled (51 men; mean age, 61.5±6.2 years). The historical control group of 100 age- and gender-matched patients with acute cholecystitis had undergone laparoscopic cholecystectomy without hemostatic agent. In the Floseal group, bleeding ceased within 10 minutes after laparoscopic application of the hemostatic agent to the gallbladder bed in all patients. The conversion rate was significantly lower in the Floseal group than in the control group (4 versus 12 patients, P<.05).ConclusionsFloseal in acute cholecystitis is safe, is effective in controlling bleeding, and results in a lower conversion rate compared with cholecystectomy without hemostatic agents.
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