Zisman Ariel, Nativ Omri, Malshy Kamil, Sadeh Omer, A. Tareq, Shabataev Valentin, Hoffman Azik, Mullerad Michael, E. Gilad
{"title":"The use of biological glue (Starsil® Hemostat) in robotic partial nephrectomy: a safety and efficacy study","authors":"Zisman Ariel, Nativ Omri, Malshy Kamil, Sadeh Omer, A. Tareq, Shabataev Valentin, Hoffman Azik, Mullerad Michael, E. Gilad","doi":"10.31083/J.JMCM.2019.03.0213","DOIUrl":null,"url":null,"abstract":"Introduction: Robotic partial nephrectomy (RPN) is a relatively safe nephron sparing surgery (NSS) approach for the treatment of small renal masses (cT1). However, a major perioperative complication is extensive bleeding and blood loss necessitating blood transfusion. This complication is most challenging during the intraoperative setting and requires proper tumor bed closure. Recently several biological tissue adhesives have been tested to decrease intraoperative bleeding. A novel adhesive, Starsil® Hemostat is a plant-derived polysaccharide that can be applied directly to a bleeding wound to achieve hemostasis. The aim of our current study was to perform an evaluation of the safety and efficacy of this novel hemostat in patients undergoing RPN. Methods: This prospective single arm study included twenty patients with T1a-T1b renal masses who underwent RPN between the years 20172018. Renal masses were classified according to size, exophytic/endophytic properties and anatomic location into low, moderate and high complexity cases as described by the R.E.N.A.L nephrometry score. Starsil® Hemostat was applied by a feeding tube through a laparoscopic port after tumor excision. Perioperative data were collected, including blood loss during surgery, blood product transfusion rates, short and long-term adverse events and surgeon satisfaction using a visual analog scale (VAS 1-10). Results: Twenty RPN surgeries were completed using the Starsil® Hemostat. The average age was 61.8 ±14.3. Average maximal tumor diameter was 3.8 cm (range 1.55.7). The calculated mean R.E.N.A.L nephrometry score was 8.4 (range 5-12). Mean blood loss during surgery was 346 mL (range 50-1400 mL). Mean surgeon satisfaction (VAS 1-10) with bleeding control was 8.3, when recorded 24 hours post operation. In 17/20 procedures (85%), bleeding control was good (VAS 9-10) and only 2 patients required blood transfusion. None of the patients developed an allergic reaction. No adverse events related to the adhesive product were noted in the post-surgical follow up period. Conclusion: Tumor bed closure during NSS with the adhesive STARSIL® Hemostat is safe, feasible and easy to use. It has the potential to reduce blood loss and transfusion rate in patients undergoing RPN. Keywords","PeriodicalId":92248,"journal":{"name":"Journal of molecular medicine and clinical applications","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2019-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of molecular medicine and clinical applications","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.31083/J.JMCM.2019.03.0213","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 1
Abstract
Introduction: Robotic partial nephrectomy (RPN) is a relatively safe nephron sparing surgery (NSS) approach for the treatment of small renal masses (cT1). However, a major perioperative complication is extensive bleeding and blood loss necessitating blood transfusion. This complication is most challenging during the intraoperative setting and requires proper tumor bed closure. Recently several biological tissue adhesives have been tested to decrease intraoperative bleeding. A novel adhesive, Starsil® Hemostat is a plant-derived polysaccharide that can be applied directly to a bleeding wound to achieve hemostasis. The aim of our current study was to perform an evaluation of the safety and efficacy of this novel hemostat in patients undergoing RPN. Methods: This prospective single arm study included twenty patients with T1a-T1b renal masses who underwent RPN between the years 20172018. Renal masses were classified according to size, exophytic/endophytic properties and anatomic location into low, moderate and high complexity cases as described by the R.E.N.A.L nephrometry score. Starsil® Hemostat was applied by a feeding tube through a laparoscopic port after tumor excision. Perioperative data were collected, including blood loss during surgery, blood product transfusion rates, short and long-term adverse events and surgeon satisfaction using a visual analog scale (VAS 1-10). Results: Twenty RPN surgeries were completed using the Starsil® Hemostat. The average age was 61.8 ±14.3. Average maximal tumor diameter was 3.8 cm (range 1.55.7). The calculated mean R.E.N.A.L nephrometry score was 8.4 (range 5-12). Mean blood loss during surgery was 346 mL (range 50-1400 mL). Mean surgeon satisfaction (VAS 1-10) with bleeding control was 8.3, when recorded 24 hours post operation. In 17/20 procedures (85%), bleeding control was good (VAS 9-10) and only 2 patients required blood transfusion. None of the patients developed an allergic reaction. No adverse events related to the adhesive product were noted in the post-surgical follow up period. Conclusion: Tumor bed closure during NSS with the adhesive STARSIL® Hemostat is safe, feasible and easy to use. It has the potential to reduce blood loss and transfusion rate in patients undergoing RPN. Keywords