中国实用外科杂志 ›› 2011, Vol. 31 ›› Issue (04): 341-345.

• 国际疝外科精粹 • 上一篇    下一篇

开放与腹腔镜下腹壁切口疝修补术术后并发症的分级和评估:前瞻性随机对照研究

Kaafarani HMA1,Hur K2,Campasano M1,Reda DJ3,Itani KMF1   

  • 出版日期:2011-04-01 发布日期:2011-05-30

  1. 1 Department of Surgery, VA Boston Healthcare System (112), 1400 VFW Parkway, West Roxbury, MA 02132, USA. 2 VA Cooperative Studies Program Coordinating Center, Hines, IL, USA, 3. Boston University School of Medicine, Boston, MA, USA
  • Online:2011-04-01 Published:2011-05-30

摘要:

目的    介绍一种针对腹部切口疝修补术后并发症的评估方法。方法    2004-2006年间,146例病人被随机分为两组,一组接受腹腔镜切口疝修补术(腹腔镜组,n = 73),另一组接受传统开放式切口疝修补术(传统组,n = 73)。研究对象是术后8周内出现的并发症。利用“三步法”来评价并发症的严重性。首先,将所有并发症根据Clavien分级分类。第二步,5位研究员分别独自运用直观叙述问卷模式对并发症的严重程度分级:0表示无术后并发症,100表示术后死亡。第三步,分别用中位数、最低和最高值对腹腔镜组与传统组术后并发症进行评价。结果    传统组术后并发症发生率要显著高于腹腔镜组(47.9% vs. 31.5%,P=0.026),而腹腔镜组术后并发症的严重度高于传统组。非参数分析显示传统组术后并发症发生率较高(四分位数间距为:开放组0-20对比腹腔镜组0-10;P = 0.049)。在敏感性比较中,中位数、最高值和最低值获得了类似结果。结论    该方法可以对两种术式术后并发症的发生做出直接评价。评估方法的合法性、可靠性和普遍性有待进一步的研究证实。

关键词: 疝, 腹壁疝, 随机试验, 术后并发症, 分级, 评估

Abstract:

Classification and valuation of postoperative complications in a randomized trial of open versus laparoscopic ventral herniorrhaphy        Kaafarani HMA*, Hur K, Campasano M, et al. * Department of Surgery, VA Boston Healthcare System (112), 1400 VFW Parkway, West Roxbury, MA 02132, USA
Corresponding author: Kaafarani HMA,E-mail: kitani@med.va.gov; kitani@va.gov
Abstract    Objective    Generic instruments used for the valuation of health states (e.g., EuroQol) often lack sensitivity to notable differences that are relevant to particular diseases or interventions. We developed a valuation methodology specifically for complications following ventral incisional herniorrhaphy (VIH). Methods    Between 2004 and 2006, 146 patients were prospectively randomized to undergo laparoscopic (n = 73) or open (n = 73) VIH. The primary outcome of the trial was complications at 8 weeks. A three-step methodology was used to assign severity weights to complications. First, each complication was graded using the Clavien classification. Second, five reviewers were asked to independently and directly rate their perception of the severity of each class using a non-categorized visual analog scale. Zero represented an uncomplicated postoperative course, while 100 represented postoperative death. Third, the median, lowest, and highest values assigned to each class of complications were used to derive weighted complication scores for open and laparoscopic VIH. Results    Open VIH had more complications than laparoscopic VIH (47.9 vs. 31.5%, respectively; P = 0.026). However, complications of laparoscopic VIH were more severe than those of open VIH. Non-parametric analysis revealed a statistically higher weighted complication score for open VIH (interquartile range: 0-20 for open vs. 0-10 for laparoscopic; P = 0.049). In the sensitivity analysis, similar results were obtained using the median, highest, and lowest weights. Conclusion    We describe a new methodology for the valuation of complications following VIH that allows a direct outcome comparison of procedures with different complication profiles. Further testing of the validity, reliability, and generalizability of this method is warranted.

Key words: hernia, randomized controlled trial;postoperative complications, classification;valuation