Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer A Multicenter Randomized Controlled Trial
Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer A Multicenter Randomized Controlled Trial
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DOI：
10.1097/sla.0000000000001829
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发表时间：
2017-02-01
影响因子：
9
通讯作者：
Rosenberg, Jacob
中科院分区：
文献类型：
--
作者：
Danielsen, Anne K.;Park, Jennifer;Rosenberg, Jacob
目的：目的是研究直肠癌切除术后，与标准手术（> 12周后闭合）相比，临时造口早期闭合（8-13天）相关的发病率和死亡率。背景：临时回肠造口可降低吻合口裂开后盆腔脓毒症的风险。然而，临时回肠造口术患有并发症，需要第二次外科手术（闭合），其自身也有并发症。临时回肠造口的早期闭合可以减少直肠癌patients.Methods的并发症：在一项多中心随机对照试验EASY（www.clinicaltrials.gov，NCT 01287637）中，将临时回肠造口的早期闭合（造口创建后8-13天）与晚期闭合（> 12周）进行了比较，该试验包括因癌症接受直肠切除术的患者。暂时性回肠造口无术后并发症迹象的患者被随机分为8 - 13天闭合组或晚期闭合组（首次手术后> 12周）。收集了长达12个月的临床数据。根据Clavien-Dindo手术并发症分类登记并发症，并计算综合并发症指数。结果：该试验包括127例患者在8个丹麦和瑞典的外科部门，和112例可供分析。术后随访12个月，干预组平均并发症发生率（1.2例）明显低于对照组（2.9例），P <0.0001。结论：直肠癌切除吻合术后8 ~ 13 d行暂时性回肠造口关闭是安全的。
Objective: The objective was to study morbidity and mortality associated with early closure (8-13 days) of a temporary stoma compared with standard procedure (closure after > 12 weeks) after rectal resection for cancer.Background: A temporary ileostomy may reduce the risk of pelvic sepsis after anastomotic dehiscence. However, the temporary ileostomy is afflicted with complications and requires a second surgical procedure (closure) with its own complications. Early closure of the temporary ileostomy could reduce complications for rectal cancer patients.Methods: Early closure (8-13 days after stoma creation) of a temporary ileostomy was compared with late closure (> 12 weeks) in a multicenter randomized controlled trial, EASY (www.clinicaltrials.gov, NCT01287637) including patients undergoing rectal resection for cancer. Patients with a temporary ileostomy without signs of postoperative complications were randomized to closure at 8 to 13 days or late closure (> 12 weeks after index surgery). Clinical data were collected up to 12 months. Complications were registered according to the Clavien-Dindo Classification of Surgical Complications, and Comprehensive Complication Index was calculated.Results: The trial included 127 patients in eight Danish and Swedish surgical departments, and 112 patients were available for analysis. The mean number of complications after index surgery up to 12 months follow up was significantly lower in the intervention group (1.2) compared with the control group (2.9), P < 0.0001.Conclusions: It is safe to close a temporary ileostomy 8 to 13 days after rectal resection and anastomosis for rectal cancer in selected patients without clinical or radiological signs of anastomotic leakage.