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直肠癌症手术是否需要肠道准备:法国 GRECCAR III 多中心单盲随机试验。

Rectal cancer surgery with or without bowel preparation: The French GRECCAR III multicenter single-blinded randomized trial.

机构信息

Department of Digestive Surgery, Beaujon Hospital, Clichy, France.

出版信息

Ann Surg. 2010 Nov;252(5):863-8. doi: 10.1097/SLA.0b013e3181fd8ea9.

Abstract

OBJECTIVE

To assess with a single-blinded, multicenter, randomized trial, the postoperative results in patients undergoing sphincter-saving rectal resection for cancer without preoperative mechanical bowel preparation (MBP).

BACKGROUND

The collective evidence from literature strongly suggests that MBP, before elective colonic surgery, is of no benefit in terms of postoperative morbidity. Very few data and no randomized study are available for rectal surgery and preliminary results conclude toward the safety of rectal resection without MBP.

METHODS

From October 2007 to January 2009, patients scheduled for elective rectal cancer sphincter-saving resection were randomized to receive preoperative MBP (ie, retrograde enema and oral laxatives) or not. Primary endpoint was the overall 30-day morbidity rate. Secondary endpoints included mortality rate, anastomotic leakage rate, major morbidity rate (Dindo III or more), degree of discomfort for the patient, and hospital stay.

RESULTS

A total of 178 patients (103 men), including 89 in both groups (no-MBP and MBP groups), were included in the study. The overall and infectious morbidity rates were significantly higher in no-MBP versus MBP group, 44% versus 27%, P = 0.018, and 34% versus 16%, P = 0.005, respectively. Regarding both anastomotic leakage and major morbidity rates, there was no significant difference between no-MBP and MBP group: 19% versus 10% (P = 0.09) and 18% versus 11% (P = 0.69), respectively. Moderate or severe discomfort was reported by 40% of prepared patients. Mortality rate (1.1% vs 3.4%) and mean hospital stay (16 vs 14 days) did not differ significantly between both groups.

CONCLUSIONS

This first randomized trial demonstrated that rectal cancer surgery without MBP was associated with higher risk of overall and infectious morbidity rates without any significant increase of anastomotic leakage rate. Thus, it suggests continuing to perform MBP before elective rectal resection for cancer.

摘要

目的

采用单盲、多中心、随机试验评估接受保肛直肠切除术的癌症患者术后结果,这些患者在术前未进行机械性肠道准备(MBP)。

背景

文献中的综合证据强烈表明,在择期结肠手术前,MBP 并不能降低术后发病率。直肠手术的相关数据非常少,也没有随机研究,初步结果表明,不进行 MBP 的直肠切除术是安全的。

方法

从 2007 年 10 月至 2009 年 1 月,对计划接受择期直肠癌保肛切除术的患者进行随机分组,接受或不接受术前 MBP(即逆行灌肠和口服轻泻剂)。主要终点是总体 30 天发病率。次要终点包括死亡率、吻合口漏发生率、主要发病率(Dindo III 级或更高级别)、患者不适程度和住院时间。

结果

共纳入 178 例患者(103 例男性),其中 89 例分别纳入无 MBP 组和 MBP 组。无 MBP 组的总发病率和感染发病率明显高于 MBP 组,分别为 44%和 27%(P=0.018)和 34%和 16%(P=0.005)。在吻合口漏和主要发病率方面,无 MBP 组与 MBP 组之间无显著差异:19%和 10%(P=0.09)和 18%和 11%(P=0.69)。有 40%接受准备的患者报告出现中度或重度不适。两组死亡率(1.1%比 3.4%)和平均住院时间(16 天比 14 天)无显著差异。

结论

这项首次随机试验表明,不进行 MBP 的直肠癌手术与更高的总体发病率和感染发病率相关,而吻合口漏发生率没有显著增加。因此,建议继续在择期直肠癌切除术前进行 MBP。

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