To Drain or Not to Drain Infraperitoneal Anastomosis After Rectal Excision for Cancer The GRECCAR 5 Randomized Trial
To Drain or Not to Drain Infraperitoneal Anastomosis After Rectal Excision for Cancer The GRECCAR 5 Randomized Trial
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DOI：
10.1097/sla.0000000000001991
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发表时间：
2017-03-01
影响因子：
9
通讯作者：
Laurent, Christophe
中科院分区：
文献类型：
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作者：
Denost, Quentin;Rouanet, Philippe;Laurent, Christophe
目的：评价直肠癌直肠手术后盆腔引流的效果。背景：盆腔脓毒症是直肠癌手术后的主要并发症之一。虽然许多研究证实了结肠切除术后引流的感染性，但直肠手术后仍存在争议。方法：这项多中心随机试验于2011-2014年间进行，采用2个平行手臂(引流与不引流)。主要终点是术后30天内的盆腔脓毒症，包括吻合口漏、盆腔脓肿和腹膜炎。次要终点是总的发病率和死亡率、再手术率、住院时间和6个月的吻合口闭合率。结果：494例患者中，25例不符合标准，469例被分析：236例有引流，233例没有引流。吻合口高度距肛缘3.5±1.9 cm。盆腔脓毒症发生率为17.1%(80/469)，置管组为16.1%，未置管组为18.0%(P=0.58)。两组手术并发症(18.7%比25.3%；P=0.83)、再手术率(16.6%比21.0%；P=0.22)、住院天数(12.2比12.2；P=0.99)和吻合口闭合率(80.1%比77.3%；P=0.53)无明显差异。没有结肠袋是盆腔脓毒症的唯一独立因素(优势比=1.757；95%可信区间1.078-2.864；P=0.024)。结论：这项随机试验表明，直肠癌切除后使用盆腔引流不会给患者带来任何好处。
Objective: To assess the effect of pelvic drainage after rectal surgery for cancer.Background: Pelvic sepsis is one of the major complications after rectal excision for rectal cancer. Although many studies have confirmed infectiveness of drainage after colectomy, there is still a controversy after rectal surgery.Methods: This multicenter randomized trial with 2 parallel arms (drain vs no drain) was performed between 2011 and 2014. Primary endpoint was postoperative pelvic sepsis within 30 postoperative days, including anastomotic leakage, pelvic abscess, and peritonitis. Secondary endpoints were overall morbidity and mortality, rate of reoperation, length of hospital stay, and rate of stoma closure at 6 months.Results: A total of 494 patients were randomized, 25 did not meet the criteria and 469 were analyzed: 236 with drain and 233 without. The anastomotic height was 3.5 +/- 1.9 cm from the anal verge. The rate of pelvic sepsis was 17.1% (80/469) and was similar between drain and no drain: 16.1% versus 18.0% (P = 0.58). There was no difference of surgical morbidity (18.7% vs 25.3%; P = 0.83), rate of reoperation (16.6% vs 21.0%; P = 0.22), length of hospital stay (12.2 vs 12.2; P = 0.99) and rate of stoma closure (80.1% vs 77.3%; P = 0.53) between groups. Absence of colonic pouch was the only independent factor of pelvic sepsis (odds ratio = 1.757; 95% confidence interval 1.078-2.864; P = 0.024).Conclusions: This randomized trial suggests that the use of a pelvic drain after rectal excision for rectal cancer did not confer any benefit to the patient.