Matthiessen Peter, Hallböök Olof, Rutegård Jörgen, Simert Göran, Sjödahl Rune
Department of Surgery, Orebro University Hospital, Orebro, Sweden.
Ann Surg. 2007 Aug;246(2):207-14. doi: 10.1097/SLA.0b013e3180603024.
The aim of this randomized multicenter trial was to assess the rate of symptomatic anastomotic leakage in patients operated on with low anterior resection for rectal cancer and who were intraoperatively randomized to a defunctioning stoma or not.
The introduction of total mesorectal excision surgery as the surgical technique of choice for carcinoma in the lower and mid rectum has led to decreased local recurrence and improved oncological results. Despite these advances, perioperative morbidity remains a major issue, and the most feared complication is symptomatic anastomotic leakage. The role of the defunctioning stoma in regard to anastomotic leakage is controversial and has not been assessed in any randomized trial of sufficient size.
From December 1999 to June 2005, a total of 234 patients were randomized to a defunctioning loop stoma or no loop stoma. Loop ileostomy or loop transverse colostomy was at the choice of the surgeon. Inclusion criteria for randomization were expected survival >6 months, informed consent, anastomosis < or =7 cm above the anal verge, negative air leakage test, intact anastomotic rings, and absence of major intraoperative adverse events.
The overall rate of symptomatic leakage was 19.2% (45 of 234). Patients randomized to a defunctioning stoma (n = 116) had leakage in 10.3% (12 of 116) and those without stoma (n = 118) in 28.0% (33 of 118) (odds ratio = 3.4; 95% confidence interval, 1.6-6.9; P < 0.001). The need for urgent abdominal reoperation was 8.6% (10 of 116) in those randomized to stoma and 25.4% (30 of 118) in those without (P < 0.001). After a follow-up of median 42 months (range, 6-72 months), 13.8% (16 of 116) of the initially defunctioned patients still had a stoma of any kind, compared with 16.9% (20 of 118) those not defunctioned (not significant). The 30-day mortality after anterior resection was 0.4% (1 of 234) and after elective reversal a defunctioning stoma 0.9% (1 of 111). Median age was 68 years (range, 32-86 years), 45.3% (106 of 234) were females, 79.1% (185 of 234) had preoperative radiotherapy, the level of anastomosis was median 5 cm, and intraoperative blood loss 550 mL, without differences between the groups.
Defunctioning loop stoma decreased the rate of symptomatic anastomotic leakage and is therefore recommended in low anterior resection for rectal cancer.
这项随机多中心试验的目的是评估接受直肠癌低位前切除术且术中随机分为行减功能造口或不行减功能造口的患者出现有症状吻合口漏的发生率。
全直肠系膜切除术作为中低位直肠癌的首选手术技术，已使局部复发率降低且肿瘤学结果得到改善。尽管有这些进展，但围手术期发病率仍然是一个主要问题，最令人担忧的并发症是有症状的吻合口漏。减功能造口在吻合口漏方面的作用存在争议，且尚未在任何规模足够大的随机试验中进行评估。
从1999年12月至2005年6月，共有234例患者被随机分为行减功能袢式造口或不行袢式造口。袢式回肠造口术或袢式横结肠造口术由外科医生选择。随机分组的纳入标准为预期生存期>6个月、知情同意、吻合口距肛缘≤7 cm、漏气试验阴性、吻合环完整以及无重大术中不良事件。
有症状漏的总体发生率为19.2%（234例中的45例）。随机分为行减功能造口的患者（n = 116）漏发生率为10.3%（116例中的12例），未行造口的患者（n = 118）为28.0%（118例中的33例）（比值比 = 3.4；9
