左半结肠憩室炎合并脓性或粪性腹膜炎行一期吻合术或 Hartmann 手术的多中心随机临床试验。
A multicenter randomized clinical trial of primary anastomosis or Hartmann's procedure for perforated left colonic diverticulitis with purulent or fecal peritonitis.
机构信息
Department of Surgery, University Hospital Zurich, Raemistrasse 100, Zurich, Switzerland.
出版信息
Ann Surg. 2012 Nov;256(5):819-26; discussion 826-7. doi: 10.1097/SLA.0b013e31827324ba.
OBJECTIVES
To evaluate the outcome after Hartmann's procedure (HP) versus primary anastomosis (PA) with diverting ileostomy for perforated left-sided diverticulitis.
BACKGROUND
The surgical management of left-sided colonic perforation with purulent or fecal peritonitis remains controversial. PA with ileostomy seems to be superior to HP; however, results in the literature are affected by a significant selection bias. No randomized clinical trial has yet compared the 2 procedures.
METHODS
Sixty-two patients with acute left-sided colonic perforation (Hinchey III and IV) from 4 centers were randomized to HP (n = 30) and to PA (with diverting ileostomy, n = 32), with a planned stoma reversal operation after 3 months in both groups. Data were analyzed on an intention-to-treat basis. The primary end point was the overall complication rate. The study was discontinued following an interim analysis that found significant differences of relevant secondary end points as well as a decreasing accrual rate (NCT01233713).
RESULTS
Patient demographics were equally distributed in both groups (Hinchey III: 76% vs 75% and Hinchey IV: 24% vs 25%, for HP vs PA, respectively). The overall complication rate for both resection and stoma reversal operations was comparable (80% vs 84%, P = 0.813). Although the outcome after the initial colon resection did not show any significant differences (mortality 13% vs 9% and morbidity 67% vs 75% in HP vs PA), the stoma reversal rate after PA with diverting ileostomy was higher (90% vs 57%, P = 0.005) and serious complications (Grades IIIb-IV: 0% vs 20%, P = 0.046), operating time (73 minutes vs 183 minutes, P < 0.001), hospital stay (6 days vs 9 days, P = 0.016), and lower in-hospital costs (US $16,717 vs US $24,014) were significantly reduced in the PA group.
CONCLUSIONS
This is the first randomized clinical trial favoring PA with diverting ileostomy over HP in patients with perforated diverticulitis.
目的
评估 Hartmann 手术（HP）与带预防性回肠造口术的一期吻合术（PA）治疗穿孔性左侧憩室炎的治疗效果。
背景
左侧结肠穿孔合并脓性或粪便性腹膜炎的手术治疗仍存在争议。带预防性回肠造口术的 PA 似乎优于 HP；然而，文献中的结果受到显著选择偏倚的影响。目前尚无随机临床试验比较这两种手术。
方法
来自 4 家中心的 62 例急性左侧结肠穿孔（Hinchey III 和 IV 期）患者被随机分为 HP 组（n = 30）和 PA 组（带预防性回肠造口术，n = 32），两组均计划在 3 个月后行造口还纳术。数据采用意向治疗分析。主要终点是总并发症发生率。在中期分析发现相关次要终点存在显著差异以及入组率下降后，研究提前终止（NCT01233713）。
结果
两组患者的人口统计学特征分布均衡（HP 组：Hinchey III 期占 76%，Hinchey IV 期占 24%；PA 组：Hinchey III 期占 75%，Hinchey IV 期占 25%）。两种手术的总并发症发生率相似（HP 组为 80%，PA 组为 84%，P = 0.813）。尽管初始结肠切除术后的结果没有显著差异（HP 组死亡率为 13%，发病率为 67%；PA 组死亡率为 9%，发病率为 75%），但带预防性回肠造口术的 PA 组的造口还纳率更高（90% vs 57%，P = 0.005），严重并发症（Grades IIIb-IV：0% vs 20%，P = 0.046）、手术时间（73 分钟 vs 183 分钟，P < 0.001）、住院时间（6 天 vs 9 天，P = 0.016）和住院费用（US $16,717 vs US $24,014）均显著降低。
结论
这是第一项支持带预防性回肠造口术的 PA 优于 HP 治疗穿孔性憩室炎的随机临床试验。
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