Abstract | BACKGROUND: 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:
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Authors | 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, Luigi Piazza |
Journal | Journal of laparoendoscopic & advanced surgical techniques. Part A
(J Laparoendosc Adv Surg Tech A)
Vol. 24
Issue 12
Pg. 837-41
(Dec 2014)
ISSN: 1557-9034 [Electronic] United States |
PMID | 25025393
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- FloSeal Matrix
- Hemostatics
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Topics |
- Adult
- Aged
- Blood Loss, Surgical
(prevention & control)
- Cholecystectomy, Laparoscopic
(methods)
- Cholecystitis, Acute
(surgery)
- Cohort Studies
- Female
- Gelatin Sponge, Absorbable
(pharmacology)
- Hemostatic Techniques
- Hemostatics
(pharmacology)
- Humans
- Male
- Middle Aged
- Postoperative Hemorrhage
(prevention & control)
- Prospective Studies
- Young Adult
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