Kane R L, Lurie N, Borbas C, Morris N, Flood S, McLaughlin B, Nemanich G, Schultz A
University of Minnesota, School of Public Health, Minneapolis 55455.
J Am Coll Surg. 1995 Feb;180(2):136-45.
The demand for evidence of effectiveness for medical care has prompted the development of epidemiologic approaches to relating the outcomes of care to treatment. This study compares the outcomes of care for patients undergoing the newly introduced laparoscopic cholecystectomy with the results from conventional open cholecystectomies.
Consecutive cases of elective cholecystectomy from 35 hospitals (all of the metropolitan and selected rural hospitals in Minnesota) were enrolled in the study. Patients were interviewed on admission to establish baseline symptoms and functional status and to confirm risk factors. Their medical records were abstracted to yield information on risk factors, treatment, and hospital complications. To establish outcomes, patients were sent a questionnaire about their symptoms and functional status six months postoperatively.
Of 3,448 patients studied, 2,490 (72 percent) had a laparoscopic procedure, including 195 cases that were converted to open cholecystectomies. Functional status data were obtained on 2,481 cases (76 percent). Laparoscopic operation was associated with more operative complications (odds ratio 3.02, p < 0.001), but with fewer general complications (odds ratio 0.32, p < 0.001). The mean time to return to work was 15 days for laparoscopic cases compared to 31 days for open procedures (p < 0.001). The only functional outcome difference between the two procedures was that patients who underwent laparoscopic cholecystectomies were more likely than those with conventional cholecystectomies to be able to perform their usual activities at follow-up evaluation (p < .001). There was evidence of a learning curve; the more laparoscopic procedures a surgeon performed, the fewer the operative (p < 0.01) and general (p < 0.0001) complications. There was no indication that the availability of laparoscopic operation was associated with more operations being performed.
Laparoscopic operation seems to represent a significant advance in getting patients back to a normal life sooner. More attention needs to be given to which patients are most likely to benefit from cholecystectomy of either type. Epidemiologic approaches can be useful in assessing the effectiveness of care. Partnerships between providers and researchers can produce useful effectiveness data by supplementing available clinical records with more detailed outcome data.
对医疗有效性证据的需求促使了将治疗结果与治疗方法相关联的流行病学方法的发展。本研究比较了接受新引入的腹腔镜胆囊切除术患者的治疗结果与传统开放性胆囊切除术的结果。
纳入了来自35家医院(明尼苏达州所有大城市和部分乡村医院)的连续择期胆囊切除术病例。患者入院时接受访谈以确定基线症状和功能状态,并确认危险因素。提取他们的病历以获取有关危险因素、治疗和医院并发症的信息。为确定治疗结果,在术后六个月向患者发送了一份关于其症状和功能状态的问卷。
在研究的3448例患者中,2490例(72%)接受了腹腔镜手术,其中195例转为开放性胆囊切除术。获得了2481例(76%)的功能状态数据。腹腔镜手术与更多的手术并发症相关(优势比3.02,p<0.001),但一般并发症较少(优势比0.32,p<0.001)。腹腔镜手术患者平均恢复工作时间为15天,而开放性手术为31天(p<0.001)。两种手术唯一的功能结果差异是,在随访评估中,接受腹腔镜胆囊切除术的患者比接受传统胆囊切除术的患者更有可能能够进行日常活动(p<0.001)。有证据表明存在学习曲线;外科医生进行的腹腔镜手术越多,手术(p<0.01)和一般(p<0.0001)并发症就越少。没有迹象表明腹腔镜手术的可用性与进行更多手术有关。
腹腔镜手术似乎在使患者更快恢复正常生活方面取得了重大进展。需要更多关注哪些患者最有可能从任何一种类型的胆囊切除术中受益。流行病学方法可用于评估医疗效果。提供者和研究人员之间的合作可以通过用更详细的结果数据补充现有临床记录来产生有用的效果数据。