An-Institut für Qualitätssicherung in der operativen Medizin, Magdeburg, Germany.
Langenbecks Arch Surg. 2010 Nov;395(8):1031-8. doi: 10.1007/s00423-010-0708-0. Epub 2010 Aug 15.
Randomized trials have demonstrated a reduction in local recurrence rate in rectal cancer patients treated with preoperative chemoradiotherapy and total mesorectal excision (TME) compared to patients undergoing TME alone. Accordingly, preoperative chemoradiotherapy in all UICC stages II and III rectal cancers has been recommended in the German treatment guidelines as of 2004. However, this policy has been questioned in recent years, partly due to concern regarding an increase in postoperative complications through preoperative therapy. Studies on this issue are sparse; most have been conducted in specialized centers, included relatively few patients, and yielded partly contradicting results. It was the aim of our analysis to investigate the influence of preoperative chemoradiotherapy on anastomotic leak rate and postoperative bladder dysfunction in rectal cancer patients using a representative data set from the Quality Assurance in Rectal Cancer Surgery multicenter observational trial.
This is a retrospective analysis of data from the Quality Assurance in Rectal Cancer Surgery prospective multicenter observational trial. Data of all patients undergoing curatively intended sphincter-preserving resection for UICC stage I through III rectal carcinoma between 01 Jan 2005 and 31 Dec 2007 with or without preoperative chemoradiotherapy (groups A and B, respectively) were included. Multivariate statistical analysis using propensity score analysis was carried out regarding outcome parameters total anastomotic leak rate, rate of anastomotic leaks requiring reoperation, and postoperative bladder dysfunction.
A total of 2,085 patients were included (group A, n = 676, group B, n = 1,409). Significant differences were present between groups regarding age, sex, distance of the tumor from the anal verge, pT-stage, UICC stage, hepatic risk factors, and use of protective enterostomy by univariate analysis. Multivariate logistic regression including these parameters was used to calculate the propensity score (likelihood to be assigned to group A or B as a consequence of the individual profile of these factors) for each patient. When outcome parameters were compared between groups A and B after stratification for propensity score, no significant differences regarding postoperative bladder dysfunction (p = 0.12), total anastomotic leak rate (p = 0.56), and anastomotic leaks requiring reoperation (p = 0.56) could be demonstrated.
Neoadjuvant chemoradiotherapy for rectal carcinoma does not increase the risk for anastomotic leakage or postoperative bladder dysfunction after curatively intended sphincter-preserving rectal resection.
与单独接受全直肠系膜切除术（TME）的直肠癌患者相比，接受术前放化疗和 TME 的患者局部复发率降低。因此，自 2004 年以来，德国治疗指南建议所有 UICC 分期 II 和 III 期直肠癌患者进行术前放化疗。然而，近年来这一政策受到了质疑，部分原因是担心术前治疗会增加术后并发症。关于这个问题的研究很少；大多数研究都是在专门的中心进行的，纳入的患者相对较少，结果也有些矛盾。我们的分析旨在使用来自直肠癌手术质量保证多中心观察性试验的代表性数据集，研究术前放化疗对直肠癌患者吻合口漏率和术后膀胱功能障碍的影响。
这是对直肠癌手术质量保证多中心观察性试验前瞻性观察性研究数据的回顾性分析。纳入 2005 年 1 月 1 日至 2007 年 12 月 31 日期间接受保肛切除术治疗 UICC 分期 I 至 III 期直肠癌且有或无术前放化疗（A 组和 B 组，分别）的所有患者的数据。使用倾向评分分析对总吻合口漏率、需要再次手术的吻合口漏发生率和术后膀胱功能障碍等结局参数进行多变量统计分析。
共纳入 2085 例患者（A 组，n=676；B 组，n=1409）。两组之间在年龄、性别、肿瘤距肛缘距离、pT 分期、UICC 分期、肝危险因素和保护性肠造口术的使用等方面存在显著差异。多变量逻辑回归分析包括这些参数，以计算每个患者的倾向评分（由于这些因素的个体特征而被分配到 A 组或 B 组的可能性）。对两组患者进行倾向评分分层后，比较术后膀胱功能障碍（p=0.12）、总吻合口漏率（p=0.56）和需要再次手术的吻合口漏（p=0.56）等结局参数时，无显著差异。
对直肠癌进行新辅助放化疗不会增加保肛直肠切除术后吻合口漏或术后膀胱功能障碍的风险。
