The use of biological glue (Starsil® Hemostat) in robotic partial nephrectomy: a safety and efficacy study

Zisman Ariel, Nativ Omri, Malshy Kamil, Sadeh Omer, A. Tareq, Shabataev Valentin, Hoffman Azik, Mullerad Michael, E. Gilad
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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
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生物胶(Starsil®止血剂)在机器人部分肾切除术中的应用:安全性和有效性研究
机器人部分肾切除术(RPN)是一种相对安全的保留肾元手术(NSS)治疗小肾肿块(cT1)的方法。然而,围手术期的主要并发症是大量出血和失血,需要输血。这种并发症在术中最具挑战性,需要适当的肿瘤床闭合。最近已经测试了几种生物组织粘接剂来减少术中出血。一种新型粘合剂,Starsil®止血剂是一种植物来源的多糖,可直接应用于出血伤口以实现止血。我们当前研究的目的是评估这种新型止血药在RPN患者中的安全性和有效性。方法:这项前瞻性单臂研究纳入了2017 - 2018年间接受RPN治疗的20例T1a-T1b肾肿块患者。根据肾肿块的大小、外生/内生性质和解剖位置,按照R.E.N.A.L肾测量评分将其分为低、中、高复杂性病例。Starsil®止血钳在肿瘤切除后通过腹腔镜口的饲管应用。采用视觉模拟量表(VAS 1-10)收集围手术期数据,包括术中出血量、血制品输血率、短期和长期不良事件以及外科医生满意度。结果:使用Starsil®止血钳完成RPN手术20例。平均年龄61.8±14.3岁。肿瘤平均最大直径3.8 cm(范围1.55.7)。计算的平均R.E.N.A.L肾测量评分为8.4分(范围5-12)。手术期间平均失血量为346 mL(范围50-1400 mL)。术后24小时记录的平均外科医生满意度(VAS 1-10)为8.3。在17/20例手术中(85%),出血控制良好(VAS 9-10),只有2例患者需要输血。没有患者出现过敏反应。术后随访期间未发现与粘接剂相关的不良事件。结论:黏附式STARSIL®止血钳在NSS术中缝合肿瘤床安全、可行、使用方便。它有可能减少RPN患者的失血量和输血率。关键字
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