Abstract：
BACKGROUND: The aim of the present study is to present the three years follow-up a randomised controlled trial that compared Hartmann\'s Procedure (HP) with sigmoidectomy with primary anastomosis (with or without defunctioning ileostomy) (PA) in a randomised design to determine the optimal treatment strategy for perforated diverticulitis with purulent or fecal peritonitis.
METHODS: Data were prospectively gathered for the first 12 months after randomization and retrospectively collected up to 36 months. The primary long-term endpoint was stoma free rate 36 months after the index procedure. Secondary outcomes were patients with a stoma at 36 months, percentage of stoma reversals, related reinterventions, parastomal/incisional hernia rates, total in hospital days including all readmissions regardless their relation to the intervention, overall morbidity and mortality.
RESULTS: Three years follow-up was completed in 119 of the originally 130 included patients, with 57 (48%) in the PA-group and 62 (52%) patients in the HP-group. 36 months stoma free rate was significantly better for patients undergoing PA compared with HP (PA 92% vs HP 81%, hazard ratio 2.326 [95% CI 1.538-3.517]; log-rank p < 0·0001). Stoma reversal rates did not significantly differ (PA 31/40(78%) versus HP 45/61(74%), p = 0.814). Overall cumulative morbidity (PA 21/57(36%) versus HP 30/62(48%), p = 0.266) and mortality (PA 6/57(11%) versus HP 7/62 (11%), p = 1.000) did not differ between groups. However, more parastomal hernias occurred in the HP-group (HP 10/62(16%) vs PA 1/57(2%), p = 0.009) and the mean total in hospital days after three years follow-up was significantly lower in the PA-group compared to the HP-group (PA 14 days (IQR 9.5-22.5) versus HP 17 days (IQR 12.5-27.5)), p = 0.025).
CONCLUSIONS: Long-term results showed that in haemodynamically stable, immunocompetent patients primary anastomosis is superior to Hartmann\'s procedure as treatment for perforated diverticulitis with respect to long-term stoma free rate, overall hospitalization and parastomal hernias.
METHODS: Data were prospectively gathered for the first 12 months after randomization and retrospectively collected up to 36 months. The primary long-term endpoint was stoma free rate 36 months after the index procedure. Secondary outcomes were patients with a stoma at 36 months, percentage of stoma reversals, related reinterventions, parastomal/incisional hernia rates, total in hospital days including all readmissions regardless their relation to the intervention, overall morbidity and mortality.
RESULTS: Three years follow-up was completed in 119 of the originally 130 included patients, with 57 (48%) in the PA-group and 62 (52%) patients in the HP-group. 36 months stoma free rate was significantly better for patients undergoing PA compared with HP (PA 92% vs HP 81%, hazard ratio 2.326 [95% CI 1.538-3.517]; log-rank p < 0·0001). Stoma reversal rates did not significantly differ (PA 31/40(78%) versus HP 45/61(74%), p = 0.814). Overall cumulative morbidity (PA 21/57(36%) versus HP 30/62(48%), p = 0.266) and mortality (PA 6/57(11%) versus HP 7/62 (11%), p = 1.000) did not differ between groups. However, more parastomal hernias occurred in the HP-group (HP 10/62(16%) vs PA 1/57(2%), p = 0.009) and the mean total in hospital days after three years follow-up was significantly lower in the PA-group compared to the HP-group (PA 14 days (IQR 9.5-22.5) versus HP 17 days (IQR 12.5-27.5)), p = 0.025).
CONCLUSIONS: Long-term results showed that in haemodynamically stable, immunocompetent patients primary anastomosis is superior to Hartmann\'s procedure as treatment for perforated diverticulitis with respect to long-term stoma free rate, overall hospitalization and parastomal hernias.
摘要：
背景：本研究的目的是提出一项为期三年的随机对照试验，该试验比较了Hartmann手术（HP）与乙状结肠切除术和原发性吻合（有或没有功能性回肠造口术）（PA）的随机设计，以确定穿孔憩室炎合并化脓性或腹膜炎的最佳治疗策略。
方法：前瞻性收集随机分组后的前12个月的数据，并回顾性收集长达36个月的数据。主要的长期终点是指数程序后36个月的无气孔率。次要结果是36个月时有造口的患者，造口逆转的百分比，相关的再干预措施，造口旁/切口疝发生率，住院天数总计，包括所有再次入院，无论其与干预措施的关系如何，总发病率和死亡率。
结果：在最初的130名患者中，有119名完成了三年的随访，PA组57例（48%），HP组62例（52%）。与HP相比，接受PA的患者36个月的造口游离率显着更好（PA92％vsHP81％，危险比2.326[95%CI1.538-3.517]；对数秩p<0·0001)。造口逆转率没有显着差异（PA31/40（78％）与HP45/61（74％），p=0.814)。总累积发病率（PA21/57（36％）与HP30/62（48％），p=0.266)和死亡率(PA6/57(11%)与HP7/62(11%)，p=1.000）组间没有差异。然而,HP组发生造口旁疝更多（HP10/62（16％）vsPA1/57（2％），p=0.009），与HP组相比，PA组三年随访后的平均住院天数显着降低（PA14天（IQR9.5-22.5）与HP17天（IQR12.5-27.5）），p=0.025)。
结论：长期结果表明，在血液动力学稳定的情况下，免疫功能正常的患者初次吻合优于Hartmann's手术治疗穿孔憩室炎的长期吻合率，总体住院和造口旁疝。
方法：前瞻性收集随机分组后的前12个月的数据，并回顾性收集长达36个月的数据。
结果：在最初的130名患者中，有119名完成了三年的随访，
结论：长期结果表明，在血液动力学稳定的情况下，
