Journal of laparoendoscopic & advanced surgical techniques. Part A · 2014
Use 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).
Клиническое исследованиеСравнительное исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Sartelli Massimo, Catena Fausto, Biancafarina Alessia, Tranà Cristian, Piccardo Andrea, Ceccarelli Graziano, Tirone Giuseppe, Agresta Ferdinando, Di Giorgio Andrea, Catani Marco, Tricarico Fausto, Buonanno Maurizio, Piazza Luigi
Аннотация
BACKGROUND: In 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 METHODS: This 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.
RESULTS: From 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).
CONCLUSIONS: Floseal in acute cholecystitis is safe, is effective in controlling bleeding, and results in a lower conversion rate compared with cholecystectomy without hemostatic agents.
SUBJECTS AND METHODS: This 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.
RESULTS: From 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).
CONCLUSIONS: Floseal in acute cholecystitis is safe, is effective in controlling bleeding, and results in a lower conversion rate compared with cholecystectomy without hemostatic agents.