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腹腔镜手术中径向扩张套管针的随机前瞻性研究。

A randomized prospective study of radially expanding trocars in laparoscopic surgery.

作者信息

Bhoyrul S, Payne J, Steffes B, Swanstrom L, Way L W

机构信息

Department of Surgery, University of California, San Francisco, San Francisco, CA 94143-0475, USA.

出版信息

J Gastrointest Surg. 2000 Jul-Aug;4(4):392-7. doi: 10.1016/s1091-255x(00)80018-9.

Abstract

Trocar injury is one of the most serious and potentially preventable complications of laparoscopic surgery. Use of a blunt rather than a cutting trocar could be expected to lessen the likelihood of this injury. Therefore complications related to laparoscopic port design were studied by comparing conventional cutting trocars with radially expanding (blunt) trocars. A multicenter, prospective, randomized clinical trial was conducted in 250 adult patients undergoing elective laparoscopic procedures at tertiary care centers and community hospitals. The patients were randomly assigned to one of two groups: group C, conventional cutting trocars; or group S, radially expanding trocars. Sixteen surgeons performed 244 elective laparoscopic procedures; six patients were removed from the study. One hundred nineteen patients were assigned to group S and 125 to group C. The groups were similar with regard to age, sex, and type of procedure. The following data were collected: intraoperative complications related to the trocars, abdominal wall bleeding, visceral or vascular injury, other complications, fascial closure, procedure time, trocar site assessment at 4 and 24 hours postoperatively, and visual analog pain scores at 4, 8, 12, and 24 hours postoperatively. Fascial defects from 10 mm or larger trocars in group C were closed; the fascial defects in group S were not closed. The trocar sites were checked for incisional hernias at late follow-up. Mean operating time was not different between the two groups (group S, 92 +/- 73 minutes; group C, 100 +/- 74 minutes). There were no episodes of intraoperative cannula site bleeding in group S compared with 16 episodes in 13 patients (P < 0.001) in group C. Postoperative wound complications were fewer in group S (13 vs. 23; P < 0.05). Although the pain scores were generally lower in group S, the differences were not significant. Only 3% of the patients in group S had fascial defects of 10 mm or greater that had to be closed. Within a follow-up period of 6 to 18 months, there have been no incisional hernias in either group. This study shows that radially expanding trocars are safe and effective, and less likely than conventional trocars to result in intraoperative or postoperative complications. The defects created by the radially expanding trocars do not have to be routinely closed.

摘要

套管针损伤是腹腔镜手术中最严重且有可能预防的并发症之一。使用钝头而非切割型套管针有望降低这种损伤的可能性。因此,通过比较传统切割套管针和径向扩张(钝头)套管针,对与腹腔镜端口设计相关的并发症进行了研究。在三级医疗中心和社区医院对250例接受择期腹腔镜手术的成年患者进行了一项多中心、前瞻性、随机临床试验。患者被随机分为两组之一:C组,传统切割套管针;或S组,径向扩张套管针。16名外科医生进行了244例择期腹腔镜手术;6例患者被排除在研究之外。119例患者被分配到S组,125例被分配到C组。两组在年龄、性别和手术类型方面相似。收集了以下数据:与套管针相关的术中并发症、腹壁出血、内脏或血管损伤、其他并发症、筋膜闭合情况、手术时间、术后4小时和24小时的套管针穿刺部位评估,以及术后4、8、12和24小时的视觉模拟疼痛评分。C组中10毫米或更大的套管针造成的筋膜缺损进行了闭合;S组的筋膜缺损未进行闭合。在后期随访中检查套管针穿刺部位是否有切口疝。两组的平均手术时间无差异(S组,92±73分钟;C组,100±74分钟)。S组术中套管针穿刺部位无出血事件,而C组13例患者中有16例出现出血事件(P<0.001)。S组术后伤口并发症较少(13例对23例;P<0.05)。虽然S组的疼痛评分总体较低,但差异不显著。S组中只有3%的患者有10毫米或更大的筋膜缺损需要闭合。在6至18个月的随访期内,两组均未出现切口疝。这项研究表明,径向扩张套管针是安全有效的,与传统套管针相比,导致术中或术后并发症的可能性更小。径向扩张套管针造成的缺损不必常规闭合。

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