基于专长的腹腔镜与小切口开腹胆囊切除术随机临床试验。

Expertise-based randomized clinical trial of laparoscopic versus small-incision open cholecystectomy.

机构信息

Department of Surgery and Perioperative Sciences, Umeå University, Umeå, Sweden.

出版信息

Br J Surg. 2013 Jun;100(7):886-94. doi: 10.1002/bjs.9133.

DOI:10.1002/bjs.9133

PMID:23640665

Abstract

BACKGROUND

Several randomized clinical trials have compared laparoscopic cholecystectomy (LC) and small-incision open cholecystectomy (SIOC). Most have had wide exclusion criteria and none was expertise-based. The aim of this expertise-based randomized trial was to compare healthcare costs, quality of life (QoL), pain and clinical outcomes after LC and SIOC.

METHODS

Patients scheduled for cholecystectomy were randomized to treatment by one of two teams of surgeons with a preference for either LC or SIOC. Each team performed their specific method (SIOC or LC) as a first-choice operation, but converted to open cholecystectomy and common bile duct exploration when necessary. Intraoperative cholangiography was carried out routinely. The intention was to include all patients undergoing cholecystectomy, including emergency operations and procedures involving surgical training for residents.

RESULTS

Some 74·9 per cent of all patients undergoing cholecystectomy were included. Of 355 patients randomized, 333 were analysed. Self-estimated QoL scores in 258 patients, analysed by the area under the curve method, were significantly lower in the SIOC group at 1 month after surgery: median 2326 (95 per cent confidence interval 2187 to 2391) compared with 2411 (2334 to 2502) for the LC group (P = 0·030). The mean(s.d.) duration of operation was shorter for SIOC: 97(41) versus 120(48) min (P < 0·001). There were no significant differences between the groups in conversion rate, pain, complications, length of hospital stay or readmissions.

CONCLUSION

SIOC had comparable surgical results but slightly worse short-term QoL compared with LC.

REGISTRATION NUMBER

NCT00370344 (http://www.clinicaltrials.gov).

摘要

背景

几项随机临床试验比较了腹腔镜胆囊切除术（LC）和小切口开腹胆囊切除术（SIOC）。大多数研究都有广泛的排除标准，而且没有基于专业知识的研究。本项基于专业知识的随机试验旨在比较 LC 和 SIOC 后的医疗保健成本、生活质量（QoL）、疼痛和临床结果。

方法

计划接受胆囊切除术的患者被随机分为两组外科医生治疗，每组医生都更倾向于使用 LC 或 SIOC。每个团队都将其特定的方法（SIOC 或 LC）作为首选手术，但在必要时转为开腹胆囊切除术和胆总管探查术。常规进行术中胆管造影。目的是包括所有接受胆囊切除术的患者，包括急诊手术和为住院医师提供手术培训的手术。

结果

所有接受胆囊切除术的患者中约有 74.9%被纳入。在 355 名随机患者中，有 333 名患者进行了分析。通过曲线下面积法分析 258 名患者的自我估计 QoL 评分，术后 1 个月 SIOC 组明显低于 LC 组：中位数为 2326（95%置信区间为 2187 至 2391），LC 组为 2411（2334 至 2502）（P = 0.030）。SIOC 的手术时间平均（标准差）更短：97（41）与 120（48）分钟（P < 0.001）。两组之间的转化率、疼痛、并发症、住院时间或再入院率均无显著差异。