Zitser Y G, Simchen E, Ferderber N, Freund H R
Hadasseh University Medical Center, Jerusalem, Israel.
Clin Perform Qual Health Care. 1997 Jul-Sep;5(3):116-22.
To utilize a naturally occurring "experiment," when introduction to laparoscopic cholecystectomy occurred in Israel; to compare the concurrent outcomes (wound infection and mortality) of laparoscopic versus open cholecystectomy; to adjust for patients' characteristics and procedural factors while making the comparisons.
Multicenter prospective follow up, including patients' interviews prior to the operation, daily information on postoperative care, a summary of the operation report and postdischarge telephone interview 15 days after surgery.
A sample of 100 consecutive cholecystectomy patients from all 20 acute-care hospitals in the country, where such operations were performed.
1,785 consecutive patients during 1991 and 1992; 1,184 had open cholecystectomy, and 601 had laparoscopic cholecystectomy.
Crude wound infection rates at 15 days were 2.3% for laparoscopic cholecystectomy and 6.3% for open cholecystectomy (odds ratio [OR], 2.8; P < .001). Crude mortality rates at 6 months were 0.17% and 3.0% for laparoscopic and open procedures, respectively (OR, 18.5; P < .004). Logistic models for infection and mortality were used to adjust for case-mix and procedural factors in the comparisons between the two operations. Adjusted ORs for open versus laparoscopic cholecystectomy were 1.9 (P = .06) for wound infection and 4.3 (P = .17) for mortality. Stratification of patients on the basis of the models into high- and low-risk strata indicated that the protective effect of laparoscopic cholecystectomy was mainly evident in the high-risk group: 1.8% versus 8.3% (P < .001) for 15-day infections and 0.6% versus 4.4% (P = .017) for 6 months mortality.
We conclude that, although the P values for the adjusted comparisons were of borderline significance (due to the small number of deaths in the laparoscopic group), our results suggest advantageous outcomes for laparoscopic cholecystectomy, especially among the high-risk patients.
利用以色列引入腹腔镜胆囊切除术这一自然发生的“实验”；比较腹腔镜胆囊切除术与开腹胆囊切除术的同期结果（伤口感染和死亡率）；在进行比较时对患者特征和手术因素进行调整。
多中心前瞻性随访，包括术前对患者的访谈、术后护理的每日信息、手术报告摘要以及术后15天出院后的电话访谈。
从该国所有20家进行此类手术的急症医院中选取100例连续接受胆囊切除术的患者作为样本。
1991年和1992年期间的1785例连续患者；1184例行开腹胆囊切除术，601例行腹腔镜胆囊切除术。
腹腔镜胆囊切除术15天时的粗伤口感染率为2.3%，开腹胆囊切除术为6.3%（优势比[OR]，2.8；P < .001）。腹腔镜和开腹手术6个月时的粗死亡率分别为0.17%和3.0%（OR，18.5；P < .004）。在两种手术的比较中，使用感染和死亡率的逻辑模型对病例组合和手术因素进行调整。开腹与腹腔镜胆囊切除术的调整后OR值，伤口感染为1.9（P = .06），死亡率为4.3（P = .17）。根据模型将患者分为高风险和低风险分层表明，腹腔镜胆囊切除术的保护作用主要在高风险组中明显：15天感染率为1.8%对8.3%（P < .001），6个月死亡率为0.6%对4.4%（P = .017）。
我们得出结论，尽管调整后比较的P值处于临界显著水平（由于腹腔镜组死亡人数较少），但我们的结果表明腹腔镜胆囊切除术有更好的结果，尤其是在高风险患者中。
