末端回肠造口早期还纳的可行性及安全性的Meta分析

doi:10.3877/cma.j.issn.2095-3224.2020.03.011

目的

通过Meta分析来评价早期还纳末端回肠造口的可行性及安全性，为造口还纳的最佳时机提供循证医学证据。

方法

检索万方、中国知网、Cochrane Library、PubMed、SpringerLink、EBSCO、MEDLINE等数据库，以"末端回肠造口" "早期还纳" "ileostomy" "early clsure" "stoma" "reversal"为检索词检索从2000年1月至2019年11月所有对比早期还纳及晚期还纳的文献，提取相关临床资料和数据，根据纳入和排除标准，并根据Cochrane文献质量评估手册和NOS量表评估文献质量，最后采用RevMan5.3进行Meta分析。

结果

最终9篇文献符合纳入标准，早期还纳组手术时间少于晚期还纳组（P= 0.0005）、造口相关并发症及肠梗阻发生率低于晚期还纳组（P<0.00001），切口感染发生率高于晚期还纳组（P<0.0001），差异均有统计学意义；术后并发症（P=0.67）、术后吻合口漏发生率（P=0.39）基本相似，差异均无统计学意义。

结论

早期还纳末端回肠造口是安全可行的，并不增加手术并发症，且能够减少造口相关并发症，提高患者的生活质量。

关键词: 回肠造口术, 末端回肠造口, 早期还纳, 晚期还纳, Meta分析

Objective

To evaluate the efficacy and safety of early closure of terminal ileostomy by Meta-analysis, and provide evidence for the optimal timing of closure of ileostomy.

Methods

The literatures comparing early closure of ileostomy with the late closure published from January 2000 to November 2019 were searched in The Wangfang, CNKI, Cochrane Library, PubMed, SpringerLink, EBSCO, MEDLINE and other databases, "ileostomy", "early clsure", "stoma", "reversal" and other words were selected as keywords, relevant clinical data were extracted according to inclusion and exclusion criteria, the quality of literature was evaluated according to Cochrane literature quality assessment manual and NOS form, the Meta-analysis was performed by RevMan5.3.

Results

A total of 9 articles were included in the Meta-analysis, the duration time of the early closure group was shorter than that of late closure group (P=0.0005), the incidence of stoma related complications and intestinal obstruction was lower than that of late closure group (P<0.00001), the wound infection rate of early closure group was higher than that of late closure group, there was significant difference (P<0.0001), and there was no significant difference in postoperative complications and anastomotic leakage (P=0.67, 0.39).

Conclusions

Early closure of terminal ileostomy is safe and feasible, does not increase the postoperative complications, and can reduce the stoma related complications, improve the patients′ quality of life.

Key words: Ileostomy, Terminal ileostomy, Early closure, Late closure, Meta-analysis

图1 检索流程图

表1 NOS量表评价非随机对照研究

非RCT研究	选择				可比性	暴露
作者	病例的定义	病例的代表性	对照的选择	对照的定义	病例和对照的可比性	暴露的评估方法	病例和对照的调查方法是否相同	无应答率
Omundsen	√	√	√	√	√	√	√	-
Robertson	√	√	√	√	√	√	√	-

表1 NOS量表评价非随机对照研究

非RCT研究	选择				可比性	暴露
作者	病例的定义	病例的代表性	对照的选择	对照的定义	病例和对照的可比性	暴露的评估方法	病例和对照的调查方法是否相同	无应答率
Omundsen	√	√	√	√	√	√	√	-
Robertson	√	√	√	√	√	√	√	-

图2 文献质量评价表

表2 纳入Meta分析研究的特征

作者	年份	地区	设计类型	病例数	年龄	性别（男/女）	合并症	直肠肿瘤位置	术前放化疗	肿瘤分期
Alves^[6]	2008	France	RCT	EC95	58	44/51	36	N/A	55	N/A
?	?	?	?	LC91	56	42/49	39	N/A	51	N/A
Krand^[7]	2008	Turkey	RCT	EC25	63	18/7	4	低位 25	25	B期20、C期4
?	?	?	?	LC25	60	16/9	5	低位 25	25	B期17、C期5
Lasithiotakis^[8]	2016	UK	RCT	EC16	63	10/6	N/A	N/A	4	N/A
?	?	?	?	LC10	61	5/5	N/A	N/A	2	N/A
Danielsen^[9]	2017	Sweden	RCT	EC55	67	24/31	23	低位 27 中位 27 高位1	16	Ⅰ期12、Ⅱ期21、Ⅲ期18、Ⅳ期3
?	?	?	?	LC57	67	36/21	24	低位 24 中位 33 高位 0	16	Ⅰ期19、Ⅱ期13、Ⅲ期20、Ⅳ期1
Klek^[5]	2018	Poland	RCT	EC29	55.7	18/11	N/A	N/A	29	Ⅰ期0、Ⅱ期17、Ⅲ期12、Ⅳ期0
?	?	?	?	LC29	56.2	16/13	N/A	N/A	29	Ⅰ期0、Ⅱ期17、Ⅲ期12、Ⅳ期0
Bausys^[10]	2019	Lithuania	RCT	EC43	65	25/18	31	低位 7 中位 27 高位 9	20	Ⅰ期16、Ⅱ期16、Ⅲ期10、Ⅳ期1
?	?	?	?	LC38	66	18/25	27	低位 8 中位 23 高位 7	19	Ⅰ期14、Ⅱ期11、Ⅲ期12、Ⅳ期1
Gallyamov^[11]	2019	Russia	RCT	EC31	62	17/14	13	低位 15 中位 15 高位 1	N/A	Ⅰ期7、Ⅱ期12、Ⅲ期10、Ⅳ期2
?	?	?	?	LC34	67	13/21	15	低位 14 中位 20 高位 0	N/A	Ⅰ期12、Ⅱ期8、Ⅲ期13、Ⅳ期1
Omundsen^[12]	2012	New Zealand	病例对照	EC19	58	9/10	N/A	N/A	N/A	N/A
?	?	?	?	LC74	59	40/34	N/A	N/A	N/A	N/A
Robertson^[13]	2015	New Zealand	病例对照	EC42	64.8	19/23	N/A	N/A	10	Ⅰ期6、Ⅱ期13、Ⅲ期15、Ⅳ期8
?	?	?	?	LC61	61.1	28/33	N/A	N/A	39	Ⅰ期5、Ⅱ期25、Ⅲ期29、Ⅳ期2

表2 纳入Meta分析研究的特征

作者	年份	地区	设计类型	病例数	年龄	性别（男/女）	合并症	直肠肿瘤位置	术前放化疗	肿瘤分期
Alves^[6]	2008	France	RCT	EC95	58	44/51	36	N/A	55	N/A
?	?	?	?	LC91	56	42/49	39	N/A	51	N/A
Krand^[7]	2008	Turkey	RCT	EC25	63	18/7	4	低位 25	25	B期20、C期4
?	?	?	?	LC25	60	16/9	5	低位 25	25	B期17、C期5
Lasithiotakis^[8]	2016	UK	RCT	EC16	63	10/6	N/A	N/A	4	N/A
?	?	?	?	LC10	61	5/5	N/A	N/A	2	N/A
Danielsen^[9]	2017	Sweden	RCT	EC55	67	24/31	23	低位 27 中位 27 高位1	16	Ⅰ期12、Ⅱ期21、Ⅲ期18、Ⅳ期3
?	?	?	?	LC57	67	36/21	24	低位 24 中位 33 高位 0	16	Ⅰ期19、Ⅱ期13、Ⅲ期20、Ⅳ期1
Klek^[5]	2018	Poland	RCT	EC29	55.7	18/11	N/A	N/A	29	Ⅰ期0、Ⅱ期17、Ⅲ期12、Ⅳ期0
?	?	?	?	LC29	56.2	16/13	N/A	N/A	29	Ⅰ期0、Ⅱ期17、Ⅲ期12、Ⅳ期0
Bausys^[10]	2019	Lithuania	RCT	EC43	65	25/18	31	低位 7 中位 27 高位 9	20	Ⅰ期16、Ⅱ期16、Ⅲ期10、Ⅳ期1
?	?	?	?	LC38	66	18/25	27	低位 8 中位 23 高位 7	19	Ⅰ期14、Ⅱ期11、Ⅲ期12、Ⅳ期1
Gallyamov^[11]	2019	Russia	RCT	EC31	62	17/14	13	低位 15 中位 15 高位 1	N/A	Ⅰ期7、Ⅱ期12、Ⅲ期10、Ⅳ期2
?	?	?	?	LC34	67	13/21	15	低位 14 中位 20 高位 0	N/A	Ⅰ期12、Ⅱ期8、Ⅲ期13、Ⅳ期1
Omundsen^[12]	2012	New Zealand	病例对照	EC19	58	9/10	N/A	N/A	N/A	N/A
?	?	?	?	LC74	59	40/34	N/A	N/A	N/A	N/A
Robertson^[13]	2015	New Zealand	病例对照	EC42	64.8	19/23	N/A	N/A	10	Ⅰ期6、Ⅱ期13、Ⅲ期15、Ⅳ期8
?	?	?	?	LC61	61.1	28/33	N/A	N/A	39	Ⅰ期5、Ⅱ期25、Ⅲ期29、Ⅳ期2

图5 早期还纳组和晚期还纳组吻合口漏的Meta分析森林图

图8 早期还纳组和晚期还纳组切口感染的Meta分析森林图

图9 早期还纳和晚期还纳组切口感染的Meta分析漏斗图

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摘要

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The safety and efficacy of early closure of terminal ileostomy: A Meta-analysis

模态框（Modal）标题

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The safety and efficacy of early closure of terminal ileostomy: A Meta-analysis