- Email: [email protected]
Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection
LETTER
would be challenging to compare all of them with one another. Nevertheless, it is an appropriate randomized controlled trial design to compare a new experimental product with a commonly used US Food and Drug Administration-approved product, despite their different mechanisms of action. Concerning the third issue of cost comparison of the 2 products, it was not an objective of this clinical trial. Ultimately, the selection of hemostatic product at the time of the operation is the surgeon’s judgment, which is based on need, experience, safety, efficacy and reliability, readiness to use, and affordability, as well as the circumstances of the operation and patient condition combined with the evidence-based approach.
Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection In Reply to Sugimachi Yuri Genyk, MD, FACS Los Angeles, CA We thank Dr Keishi Sugimachi for his comments on our article.1 Dr Sugimachi brought up 3 issues with our trial. The first issue focused on the feasibility of using an oxidized regenerated cellulose patch for temporary hemostasis and a fibrin sealant patch during the final stage of the procedure. Although in the routine setting this might be a reasonable option, in the setting of a randomized controlled trial, the conditions for application of the 2 products had to be comparable in both study arms. With regard to differences in the versatility of these 2 study products, this clinical trial was not designed to address this issue. The second issue raised was the preference for using the product from the same class in the control group of the study. There are several fibrin sealant products, and it
ª 2016 by the American College of Surgeons. Published by Elsevier Inc. All rights reserved.
REFERENCE 1. Genyk Y, Kato T, Pomposelli JJ, et al. Fibrin sealant patch (TachoSil) vs oxidized regenerated cellulose patch (Surgicel Original) for the secondary treatment of local bleeding in patients undergoing hepatic resection: a randomized controlled trial. J Am Coll Surg 2016;222:261e268.
Disclosure Information: Nothing to disclose.
1
http://dx.doi.org/10.1016/j.jamcollsurg.2016.04.038 ISSN 1072-7515/16
would be challenging to compare all of them with one another. Nevertheless, it is an appropriate randomized controlled trial design to compare a new experimental product with a commonly used US Food and Drug Administration-approved product, despite their different mechanisms of action. Concerning the third issue of cost comparison of the 2 products, it was not an objective of this clinical trial. Ultimately, the selection of hemostatic product at the time of the operation is the surgeon’s judgment, which is based on need, experience, safety, efficacy and reliability, readiness to use, and affordability, as well as the circumstances of the operation and patient condition combined with the evidence-based approach.
Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection In Reply to Sugimachi Yuri Genyk, MD, FACS Los Angeles, CA We thank Dr Keishi Sugimachi for his comments on our article.1 Dr Sugimachi brought up 3 issues with our trial. The first issue focused on the feasibility of using an oxidized regenerated cellulose patch for temporary hemostasis and a fibrin sealant patch during the final stage of the procedure. Although in the routine setting this might be a reasonable option, in the setting of a randomized controlled trial, the conditions for application of the 2 products had to be comparable in both study arms. With regard to differences in the versatility of these 2 study products, this clinical trial was not designed to address this issue. The second issue raised was the preference for using the product from the same class in the control group of the study. There are several fibrin sealant products, and it
ª 2016 by the American College of Surgeons. Published by Elsevier Inc. All rights reserved.
REFERENCE 1. Genyk Y, Kato T, Pomposelli JJ, et al. Fibrin sealant patch (TachoSil) vs oxidized regenerated cellulose patch (Surgicel Original) for the secondary treatment of local bleeding in patients undergoing hepatic resection: a randomized controlled trial. J Am Coll Surg 2016;222:261e268.
Disclosure Information: Nothing to disclose.
1
http://dx.doi.org/10.1016/j.jamcollsurg.2016.04.038 ISSN 1072-7515/16