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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. |
