A Randomized Controlled Trial Comparing Post-operative Pain in Single-Incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
A Randomized Controlled Trial Comparing Post-operative Pain in Single-Incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
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DOI：
10.1007/s00268-014-2903-6
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发表时间：
2015-04-01
影响因子：
2.6
通讯作者：
Madhavan, Krishnakumar
中科院分区：
文献类型：
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作者：
Chang, Stephen Kin Yong;Wang, Yi Liang;Madhavan, Krishnakumar
关于单切口腹腔镜胆囊切除术（SILC）的证据越来越多，但还没有充分评价术后疼痛的有效性试验。这项随机试验比较了SILC和四孔腹腔镜胆囊切除术（LC），术后疼痛作为主要终点，100名患者随机分为SILC（n = 50）和LC（n = 50）。排除标准为（1）急性胆囊炎;（2）阿萨3级或以上;（3）出血性疾病;（4）既往开放性上腹部手术。患者和术后评估者对所进行的手术不知情。使用视觉模拟量表在术后4小时、24小时、14天和6个月时比较疼痛部位和严重程度;当差异的95%置信区间的下限大于-1时，假定为非劣效性，当p <0.05时，假定为优效性。研究组在人口统计学上相似。术后24小时，SILC与脐外部位疼痛减轻相关（休息：p = 0.004;运动：p = 0.008）。24 h时运动时脐部疼痛数据不确定; SILC在所有其他点的疼痛方面均非劣效。SILC的手术持续时间较长（79.46 vs 58.88 min，p = 0.003）。每组中8%的患者发生并发症（p = 1.000）。再次介入率、镇痛剂使用、功能恢复和患者满意度无显著差异。SILC与LC相比改善了短期疼痛结局，并且在短期和长期疼痛结局方面均不劣于LC。手术时间较长，但在常规手术实践中仍然可行。
An increasing body of evidence is being published about single-incision laparoscopic cholecystectomy (SILC), but there are no well-powered trials with an adequate evaluation of post-operative pain. This randomized trial compares SILC against four-port laparoscopic cholecystectomy (LC) with post-operative pain as the primary endpoint.Hundred patients were randomized to either SILC (n = 50) or LC (n = 50). Exclusion criteria were (1) Acute cholecystitis; (2) ASA 3 or above; (3) Bleeding disorders; and (4) Previous open upper abdominal surgery. Patients and post-operative assessors were blinded to the procedure performed. The site and severity of pain were compared at 4 h, 24 h, 14 days and 6 months post-procedure using the visual analog scale; non-inferiority was assumed when the lower boundary of the 95 % confidence interval of the difference was above -1 and superiority when p a parts per thousand currency sign 0.05.The study arms were demographically similar. At 24 h post-procedure, SILC was associated with less pain at extra-umbilical sites (rest: p = 0.004; movement: p = 0.008). Pain data were inconclusive at 24 h at the umbilical site on movement; SILC was otherwise non-inferior for pain at all other points. Operating duration was longer in SILC (79.46 vs 58.88 min, p = 0.003). 8 % of patients in each arm suffered complications (p = 1.000). Re-intervention rates, analgesic use, return to function, and patient satisfaction did not differ significantly.SILC has improved short-term pain outcomes compared to LC and is not inferior in both short-term and long-term pain outcomes. The operating time is longer, but remains feasible in routine surgical practice.