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Laparoscopy versus open distal gastrectomy by expert surgeons for early gastric cancer in Japanese patients: Short-term clinical outcomes of a randomized clinical trial

机译:专家对日本患者早期胃癌的腹腔镜手术与开放式远端胃切除术的比较:一项随机临床试验的近期临床结果

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Background: Short-term outcomes of laparoscopy-assisted distal gastrectomy (LADG) and open DG (ODG) have been investigated in previous clinical trials, but operative techniques and concomitant treatments have evolved, and up-to-date evidence produced by expert surgeons is required to provide an accurate image of the relative efficacies of the treatments. The purpose of this study was to compare laparoscopic versus ODG with respect to specific primary and secondary short-term outcomes. Methods: From October 2005 to February 2008, a total of 64 patients with early gastric cancer were randomly assigned to the LADG or the ODG group. One patient was excluded due to concurrent illness unrelated to the intervention, so the data from 63 patients were analyzed. The primary short-term outcome was the 4-day postoperative use of analgesics. Secondary short-term outcomes were postoperative residual pain, complications, days hospitalized, blood data, days with fever, and days to first flatus. Results: There was a significant difference in favor of LADG for postoperative use of analgesics (P = 0.022). Unexpectedly, there was no significant difference in degree of pain in the immediate postoperative period, putatively due to the optimal use of analgesics. Of the secondary outcomes, residual pain at postoperative day 7 (P = 0.003) and days to first flatus (P = 0.001) were significantly better with LADG. Postoperative complications, number of days hospitalized, and number of days with fever were also better with LADG, but the differences were not significant. Blood data representing inflammation (WBC and CRP) showed marked differences, especially on postoperative day 7 (P = 0.0016 and P = 0.0061, respectively). Conclusions: LADG performed by expert surgeons results in less postoperative pain accompanied by decreased surgical invasiveness and is associated with fewer postoperative inconveniences. No preliminary suggestions of changes in long-term curability were observed. LADG for early gastric cancer is a feasible and safe procedure with short-term clinical results superior to those of ODG.
机译:背景:腹腔镜辅助远端胃切除术(LADG)和开放性DG(ODG)的短期结局已在先前的临床试验中进行了研究,但是手术技术和伴随疗法已得到发展,并且由外科医生提供的最新证据是需要提供有关治疗相对效果的准确图像。这项研究的目的是针对特定的主要和次要短期结果比较腹腔镜与ODG。方法:2005年10月至2008年2月,将64例早期胃癌患者随机分为LADG组或ODG组。由于并发疾病与干预无关,因此排除了一名患者,因此分析了63名患者的数据。主要的短期结果是术后4天使用镇痛药。次要的短期结果是术后残余疼痛,并发症,住院天数,血液数据,发烧天数和首次肠胃气胀的天数。结果:LADG用于术后镇痛药的使用存在显着差异(P = 0.022)。出乎意料的是,由于最佳使用了镇痛药,术后不久疼痛程度没有明显差异。在次要结果中,LADG可显着改善术后第7天的残余疼痛(P = 0.003)和第一次肠胃气胀的天数(P = 0.001)。 LADG的术后并发症,住院天数和发烧天数也更好,但差异不显着。代表炎症(WBC和CRP)的血液数据显示出显着差异,尤其是在术后第7天(分别为P = 0.0016和P = 0.0061)。结论:由专家外科医生进行的LADG可以减轻术后疼痛,并减少手术侵袭性,并减少术后不便。没有观察到长期固化性变化的初步建议。 LADG用于早期胃癌是一种可行且安全的方法,其短期临床结果优于ODG。

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