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摘要译文
我们感谢凯莱教授的来信，并饶有兴趣地阅读了他对我们手稿的评论。有人对我们的研究方法提出了关注，其中的数据表明，更好地遵守ERAS的术前和术中因素可能与提高非转移性结直肠癌腹腔镜手术患者的生存率有关。我们同意这项研究有局限性，但从收到的评论中，我们理解有一些问题需要澄清。首先，正如本文所述，我们有意关注手术前和手术中ERAS的因素。这些元素之所以选择它们，是因为它们都是主要由医护工作者决定的护理项目。术后因素如饮水、口服喂养、动员等均依赖于前一阶段的依从性，可视为预后。如果病人体内液体过多，麻醉不当等，肠道就会瘫痪，导致胀痛，阻碍活动。正如凯莱教授所指出的，这些因素与短期结果有关。在这篇文章中，我们也报道了这些术前和术中元素更好的依从性可以带来更快的恢复。由于这些原因，这种特定的依从性计算方法已在以前的论文中使用。我们赞成，在论文中提供详细的依从性数据会更好，我们很感激该期刊允许我们现在发布这些数据来完成信息。我们也承认我们的结果时间比凯莱报告的要长。缺乏关于化疗类型的精确信息是本研究的一个局限，这一点在论文中已经明确说明。然而，有人可能会说，由于患者来自同一时期、同一机构，化疗的类型很可能在各组间分布类似。如果组与组之间存在差异，可以合理地假设这是由于患者术后的情况，如较高的并发症发生率导致延迟或错过RIOT (回到预期的肿瘤治疗)。并发症在依从性较低的一组中也更为常见，再次说明了这一点。最后，我们也对年龄较大、ASA水平较高等群体对这种关联有重要影响的倾向表示怀疑。分析表明，350例病例足以为我们发现的相关性提供可靠的统计支持。我们避免使用“倾向于不显着差异值”这一术语。此外，Kehlet教授指出变量中的P值大多大于0.3，我们觉得很难将其定义为趋势。综上所述，我们意识到我们研究的局限性，因此，我们确实在原稿中进行了写作对结果的解释必须谨慎。尽管如此，我们发现发表这些数据是有用的，因为它们表明腹腔镜结直肠癌手术与开放手术的相关性相同，即术前和术中依从性低与术后早期并发症和长期生存率有关。我们期待其他研究(最好是随机对照试验)的长期结果来证实或反驳我们的发现。
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Authors’ Reply: Compliance with the ERAS Protocol and 3-Year Survival After Laparoscopic Surgery for Nonmetastatic Colorectal Cancer
Pędziwiatr M, Pisarska M, Ljungqvist OWorld J Surg.doi: 10.1007/s00268-019-05168-8.
We thank Prof. Kehlet for his letter and read with interest his comments on our manuscript . Concerns were raised about the methodology of our study where the >Firstly, as stated in the paper, we deliberately focused on pre- and intra-operative ERAS elements. These elements are chosen because they are all care items that are mainly subject to staff decisions. Postoperative elements such as drinking, oral feeding, and mobilization are all dependent on the compliance in the previous phases and can thus be regarded as outcomes. If the patient is overloaded with fluids, given the wrong anesthesia, etc., intestines will be paralyzed causing distention and pain and hinder mobilization. Not surprisingly these elements have, as Prof. Kehlet points out, repeatedly been also associated with short-term outcomes. In this paper, we also reported faster recovery of these elements with better pre- and intra-operative compliance. For these reasons, this specific way of compliance calculation, using only element preoperatively and through the day of surgery, has been used in previous papers. We agree that it would have been better to provide the compliance data in detail in the paper, and we are grateful that the journal allows us to publish them now to complete the information. We also acknowledge that our length of stay was longer than those reported from Kehlet. The lack of precise information on the type of chemotherapy is a limitation of the study, and this has been clearly stated in the paper. However, one could argue that the type of chemotherapy is likely to be similarly distributed between groups since the patients are recruited from the same period and from the same institution. If there were discrepancies between groups, it is reasonable to assume this to be due to the postoperative condition of the patient, such as higher complication rates that caused delayed or missed RIOT (Return to Intended Oncologic Treatment). Complications were also more frequent in the lower compliance group, again pointing to the same association.Finally, we respectfully disagree that there are trends and tendencies in the groups (older, higher ASA, etc.) that had a major influence on the association we have found. The analysis performed shows that a group of 350 cases was large enough to provide reliable statistical support for the associations we have found. We have avoided the use of the term tendency to nonsignificant differences values. Besides, most of P values in variables pointed out by Prof. Kehlet are greater than 0.3 which we feel is hard to label as a trend.In summary, we are aware of the limitations of our study, and for this reason, we did write in the manuscript the results have to be interpreted with caution. Still, we found it useful to publish these data, since they show the same association for laparoscopic colorectal cancer surgery as has been shown for open surgery, namely that low pre- and intra-operative compliance is associated with early postoperative complications and long-term survival. We look forward to long-term results from other studies (preferably RCTs) to confirm or contradict our findings.
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