Contant Caroline M E, Hop Wim C J, van't Sant Hans Pieter, Oostvogel Henk J M, Smeets Harm J, Stassen Laurents P S, Neijenhuis Peter A, Idenburg Floris J, Dijkhuis Cees M, Heres Piet, van Tets Willem F, Gerritsen Jos J G M, Weidema Wibo F
Department of Surgery, Ikazia Hospital, Rotterdam, Netherlands.
Lancet. 2007 Dec 22;370(9605):2112-7. doi: 10.1016/S0140-6736(07)61905-9.
Mechanical bowel preparation is a common practice before elective colorectal surgery. We aimed to compare the rate of anastomotic leakage after elective colorectal resections and primary anastomoses between patients who did or did not have mechanical bowel preparation.
We did a multicentre randomised non-inferiority study at 13 hospitals. We randomly assigned 1431 patients who were going to have elective colorectal surgery to either receive mechanical bowel preparation or not. Patients who did not have mechanical bowel preparation had a normal meal on the day before the operation. Those who did were given a fluid diet, and mechanical bowel preparation with either polyethylene glycol or sodium phosphate. The primary endpoint was anastomotic leakage, and the study was designed to test the hypothesis that patients who are given mechanical bowel preparation before colorectal surgery do not have a lower risk of anastomotic leakage than those who are not. The median follow-up was 24 days (IQR 17-34). We analysed patients who were treated as per protocol. This study is registered with ClinicalTrials.gov, number NCT00288496.
77 patients were excluded: 46 who did not have a bowel resection; 21 because of missing outcome data; and 10 who withdrew, cancelled, or were excluded for other reasons. The rate of anastomotic leakage did not differ between both groups: 32/670 (4.8%) patients who had mechanical bowel preparation and 37/684 (5.4%) in those who did not (difference 0.6%, 95% CI -1.7% to 2.9%, p=0.69). Patients who had mechanical bowel preparation had fewer abscesses after anastomotic leakage than those who did not (2/670 [0.3%] vs 17/684 [2.5%], p=0.001). Other septic complications, fascia dehiscence, and mortality did not differ between groups.
We advise that mechanical bowel preparation before elective colorectal surgery can safely be abandoned.
肠道机械性准备是择期结直肠手术前的常见操作。我们旨在比较接受或未接受肠道机械性准备的患者在择期结直肠切除及一期吻合术后吻合口漏的发生率。
我们在13家医院进行了一项多中心随机非劣效性研究。我们将1431例计划进行择期结直肠手术的患者随机分为两组,一组接受肠道机械性准备,另一组不接受。未接受肠道机械性准备的患者在手术前一天正常饮食。接受肠道机械性准备的患者给予流食,并使用聚乙二醇或磷酸钠进行肠道机械性准备。主要终点是吻合口漏,该研究旨在检验以下假设:结直肠手术前接受肠道机械性准备的患者发生吻合口漏的风险并不低于未接受准备的患者。中位随访时间为24天(四分位间距17 - 34天)。我们对按方案接受治疗的患者进行了分析。本研究已在ClinicalTrials.gov注册,注册号为NCT00288496。
77例患者被排除:46例未进行肠道切除;21例因缺少结局数据;10例因撤回、取消或其他原因被排除。两组的吻合口漏发生率无差异:接受肠道机械性准备的患者中有32/670(4.8%)发生吻合口漏,未接受准备的患者中有37/684(5.4%)发生吻合口漏(差异0.6%,95%置信区间 -1.7%至2.9%,p = 0.69)。发生吻合口漏后,接受肠道机械性准备的患者发生脓肿的情况少于未接受准备的患者(2/670 [0.3%] 对比17/684 [2.5%],p = 0.001)。其他感染性并发症、筋膜裂开及死亡率在两组间无差异。
我们建议择期结直肠手术前可安全地放弃肠道机械性准备。