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Laparoscopic cholecystectomy by ultrasonic dissection without cystic duct and artery ligature.

机译:腹腔镜胆囊切除术采用超声解剖,无胆囊管和动脉结扎。

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BACKGROUND: Laparoscopic cholecystectomy (LC) is the gold standard treatment of gallstones. Nevertheless, there are some pitfalls due to the limits of current technology and the use of inappropriate ligature material, with a relevant risk of injuries and postoperative, mainly biliary, complications. Ultrasonically activated scissors may divide both vessels and cystic duct, with no need of further ligature, and possibly reduce the risk of thermal injuries. METHODS: A prospective nonrandomized clinical trial was started in 1999 to test harmonic shears (Ultracision, Ethicon Endo-Surgery, Cincinnati, OH, USA) in 461 consecutive patients undergoing LC in order to evaluate the theoretical benefits of ultrasonic dissection and the possible reduction in intraoperative bile duct injuries (BDIs) and postoperative complications. Patients were divided in two groups: in group 1 (HS; 331 patients) the operation was performed by Ultracision (including coagulation-division of cystic duct and artery); in group 2 (LOOP;130 patients) the cystic duct, after coagulation-division by harmonic scissors, was further secured with an endo-loop. Both groups were further divided into two subgroups: expert and surgeon-in-training. The following categories of data were collected and analyzed: individual patient data, indication for laparoscopic cholecystectomy, surgical procedure data (associated procedures, intraoperative cholangiography, intraoperative complications, length of surgery, and conversion to open), and postoperative course data (postoperative morbidity, postoperative mortality, reinterventions, and postoperative hospital stay). Furthermore, biliary complications were analyzed as a single parameter comparing the incidence within groups and subgroups. Cumulative complications (intraoperative and postoperative) were also analyzed as a single parameter comparing their incidence in the series of each surgeon within the surgeon-in-training subgroup to the average results of the expert subgroup. Finally, length of surgery, postoperative complication rate, and length of postoperative hospital stay within subgroups were analyzed to evaluate the learning curve. RESULTS: Overall conversion rate was 0.87%. The mean operating time was 76.8 min (median, 70 min) in group 1 and 97.5 min (median 90 min) in group 2. BDI occurred in 1 case (0.32%) in the surgeon-in-training subgroup. Overall BDI rate was 0.22% (1/461). The overall incidence of postoperative bile leak was 2.7% (9 patients of subgroup 1 and 1 patient of subgroup 2). Clinical observation with spontaneous resolution occurred in 4 patients, and in 1 case the management consisted in an endoscopic biliary drainage; surgery was requested in the remaining cases. A laparoscopic approach was successfully attempted in all cases. Overall morbidity rate was 8.76% in group 1 and 13.84% in group 2. Rates of major complications, overall biliary complication, and postoperative bile leaks within the expert and surgeon-in-training subgroup differ significantly (p = 0.026, p = 0.03, and p = 0.049, respectively). There was 1 death (0.22%) due to sepsis that resulted from a small bowel injury by trocar insertion. Mean postoperative stay was 4.28 days for group 1 and 5.05 days for group 2. CONCLUSION: No significant difference was found in both patient groups regarding postoperative mortality and complications, biliary complications, and especially cystic duct leaks. A retrospective comparison of literature data showed that use of ultrasonic dissection during LC seems to reduce the risk of BDI. Nevertheless, a learning curve in the use of ultrasonic-activated devices is required: a significant differences in postoperative major complications and biliary complications between the expert and the surgeon-in-training subgroups was shown. Furthermore, ultrasonic scissors misuse may cause bowel injuries in patients with severe adhesions, and this could represent a possible limitation for surgical safety.
机译:背景:腹腔镜胆囊切除术(LC)是治疗胆结石的金标准。然而,由于当前技术的局限性以及使用不合适的结扎材料,存在一些陷阱,存在受伤和术后并发症(主要是胆道并发症)的相关风险。超声激活的剪刀可以将血管和胆囊管分开,而无需进一步的结扎,并可能降低热损伤的风险。方法:一项于1999年开始的前瞻性非随机临床试验在461名接受LC的连续患者中测试谐波切变(Ultracision,Ethicon Endo-Surgery,Cincinnati,OH,USA),以评估超声解剖的理论益处和可能的减少术中胆管损伤(BDI)和术后并发症。将患者分为两组:第一组(HS; 331例),手术通过超声检查(包括对胆囊管和动脉的凝结划分)进行;在第2组(LOOP; 130例患者)中,通过谐波剪刀将其分割后,用内环进一步固定胆囊管。两组都进一步分为两个子组:专家组和培训中的外科医生。收集并分析了以下几类数据:个人患者数据,腹腔镜胆囊切除术的适应症,手术程序数据(相关程序,术中胆道造影,术中并发症,手术时间和手术时间)以及术后病程数据(术后发病率,术后死亡率,再次干预和术后住院时间)。此外,将胆道并发症作为单个参数进行分析,比较各组和亚组内的发生率。还对累积并发症(术中和术后)作为单个参数进行了分析,将其在培训外科医生亚组中每个外科医生系列中的发生率与专家亚组的平均结果进行比较。最后,分析了亚组内的手术时间,术后并发症发生率和术后住院时间,以评估学习曲线。结果:整体转化率为0.87%。第1组的平均手术时间为76.8分钟(中位数为70分钟),第2组的平均手术时间为97.5分钟(中位数为90分钟)。在接受培训的外科医生亚组中,有1例发生BDI(占0.32%)。总体BDI率为0.22%(1/461)。术后胆漏的总发生率为2.7%(第1组为9例,第2组为1例)。自发消退的临床观察发生在4例患者中,其中1例采用内镜下胆道引流。其余病例均要求手术治疗。在所有情况下均成功尝试了腹腔镜手术。第一组的总发病率为8.76%,第二组的总发病率为13.84%。专家组和接受培训的亚组中的主要并发症,总体胆道并发症和术后胆漏的发生率显着不同(p = 0.026,p = 0.03,和p = 0.049)。插入套管针引起的小肠损伤导致败血症导致1例死亡(0.22%)。第一组的平均术后住院时间为4.28天,第二组的平均术后住院时间为5.05天。结论:两组患者的术后死亡率和并发症,胆道并发症,尤其是胆囊管漏出均无显着差异。文献资料的回顾性比较显示,LC期间使用超声解剖似乎可以降低BDI的风险。尽管如此,在使用超声激活设备时仍需要学习曲线:专家和接受培训的外科医生亚组在术后主要并发症和胆道并发症方面存在显着差异。此外,超声剪刀的误操作可能会对严重粘连的患者造成肠损伤,这可能代表手术安全性受到限制。

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