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一项使用荧光血管造影术研究结直肠吻合口灌注情况的研究:FLAG随机试验结果

A study investigating the perfusion of colorectal anastomoses using fluorescence angiography: results of the FLAG randomized trial.

作者信息

Alekseev M, Rybakov E, Shelygin Y, Chernyshov S, Zarodnyuk I

机构信息

State Scientific Centre of Coloproctology, Moscow, Russia.

Russian Medical Academy of Continuous Professional Education, Moscow, Russia.

出版信息

Colorectal Dis. 2020 Sep;22(9):1147-1153. doi: 10.1111/codi.15037. Epub 2020 Apr 6.

Abstract

AIM

Our aim was to evaluate the efficacy of indocyanine green (ICG) fluorescence angiography (FA) in reducing the incidence of anastomotic leakage (AL) following colorectal anastomosis.

METHOD

A single-centre randomized trial was undertaken between 2018 and 2019. Those patients who underwent a stapled colorectal anastomosis were randomized 1:1 for ICG FA versus visual clinical assessment of blood perfusion of the anastomosed colon and rectal stump (non-ICG FA group). The primary end-point was to assess whether ICG FA was associated with a reduction in the incidence of AL. Secondary outcomes were the rate of postoperative complications and change in the level of bowel resection.

RESULTS

A total of 380 patients undergoing sigmoid and rectal resection were enrolled. After randomization, three patients were excluded. The results of 377 cases were available for analysis; 187 had ICG FA and 190 were in the non-ICG FA group. ICG FA identified impaired blood perfusion of the colon in 36 (19%) cases. An AL (grade A, B or C) developed in 48 patients: 17 (9.1%) in the ICG FA group and 31 (16.3%) in the non-ICG FA group (P = 0.04). ICG FA did not decrease the rate of AL of high anastomoses (9-15 cm from the anal verge), at 1.3% vs 4.6% in the non-ICG FA group (P = 0.37). In contrast, a decrease in AL rate was found for low (4-8 cm) colorectal anastomoses (14.4% in ICG FA vs 25.7% in the non-ICG FA group; P = 0.04).

CONCLUSION

ICG FA is associated with a reduction in AL following low anterior resection.

摘要

目的

本研究旨在评估吲哚菁绿(ICG)荧光血管造影(FA)在降低结直肠吻合术后吻合口漏(AL)发生率方面的疗效。

方法

于2018年至2019年开展了一项单中心随机试验。对接受吻合器结直肠吻合术的患者按1:1随机分组,分别接受ICG FA检查以及对吻合的结肠和直肠残端血运进行视觉临床评估(非ICG FA组)。主要终点是评估ICG FA是否与AL发生率降低相关。次要结局包括术后并发症发生率和肠切除水平的变化。

结果

共有380例行乙状结肠和直肠切除术的患者入组。随机分组后,排除3例患者。377例患者的结果可供分析;187例接受ICG FA检查,190例在非ICG FA组。ICG FA检查发现36例(19%)患者结肠血运受损。48例患者发生AL(A级、B级或C级):ICG FA组17例(9.1%),非ICG FA组31例(16.3%)(P = 0.04)。ICG FA未降低高位吻合(距肛缘9 - 15 cm)的AL发生率,ICG FA组为1.3%,非ICG FA组为4.6%(P = 0.37)。相比之下,低位(4 - 8 cm)结直肠吻合的AL发生率有所降低(ICG FA组为14.4%,非ICG FA组为25.7%;P = 0.04)。

结论

ICG FA与低位前切除术后AL发生率降低相关。

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