Department of Surgical Science, University of Cagliari, Cagliari, Italy.
Emergency Surgery Unit, Cagliari University Hospital "D. Casula", Azienda Ospedaliero-Universitaria Di Cagliari, Cagliari, Italy.
Int J Colorectal Dis. 2022 Apr;37(4):737-756. doi: 10.1007/s00384-022-04106-w. Epub 2022 Feb 21.
We performed a systematic review and meta-analysis with trial sequential analysis (TSA) to answer whether early closure of defunctioning ileostomy may be suitable after low anterior resection.
MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched, up to October 2021, for RCTs comparing early closure (EC ≤ 30 days) and delayed closure (DC ≥ 60 days) of defunctioning ileostomy. The risk ratio (RR) with 95% CI was calculated for dichotomous variables and the mean difference (MD) with 95% CI for continuous variables. The GRADE methodology was implemented for assessing Quality of Evidence (QoE). TSA was implemented to address the risk of random error associated with sparse data and/or multiple testing.
Seven RCTs were included for quantitative synthesis. 599 patients were allocated to either EC (n = 306) or DC (n = 293). EC was associated with a higher rate of wound complications compared to DC (RR 2.56; 95% CI 1.33 to 4.93; P = 0.005; I = 0%, QoE High), a lower incidence of postoperative small bowel obstruction (RR 0.46; 95% CI 0.24 to 0.89; P = 0.02; I = 0%, QoE moderate), and a lower rate of stoma-related complications (RR 0.26; 95% CI 0.16 to 0.42; P < 0.00001; I = 0%, QoE moderate). The rate of minor low anterior resection syndrome (LARS) (RR 1.13; 95% CI 0.55 to 2.33; P = 0.74; I = 0%, QoE low) and major LARS (RR 0.80; 95% CI 0.59 to 1.09; P = 0.16; I = 0%, QoE low) did not differ between the two groups. TSA demonstrated inconclusive evidence with insufficient sample sizes to detect the observed effects.
EC may confer some advantages compared with a DC. However, TSA advocated a cautious interpretation of the results.
CRD42021276557.
我们进行了一项系统评价和荟萃分析,并结合试验序贯分析(TSA)来回答低位前切除术(LAR)后早期关闭预防性回肠造口术是否合适。
检索 MEDLINE、EMBASE 和 Cochrane 对照试验中心注册库,截至 2021 年 10 月,以比较早期关闭(EC ≤ 30 天)和延迟关闭(DC ≥ 60 天)预防性回肠造口术的 RCT。采用风险比(RR)和 95%置信区间(CI)表示二分类变量,采用均数差值(MD)和 95%CI 表示连续变量。采用 GRADE 方法评估证据质量(QoE)。实施 TSA 以解决稀疏数据和/或多次检验相关的随机误差风险。
纳入 7 项 RCT 进行定量综合分析。599 例患者被分配至 EC(n = 306)或 DC(n = 293)组。与 DC 组相比,EC 组的切口并发症发生率更高(RR 2.56;95%CI 1.33 至 4.93;P = 0.005;I² = 0%,QoE 高),术后小肠梗阻发生率更低(RR 0.46;95%CI 0.24 至 0.89;P = 0.02;I² = 0%,QoE 中),造口相关并发症发生率更低(RR 0.26;95%CI 0.16 至 0.42;P < 0.00001;I² = 0%,QoE 中)。两组之间的轻度低位前切除综合征(LARS)发生率(RR 1.13;95%CI 0.55 至 2.33;P = 0.74;I² = 0%,QoE 低)和重度 LARS 发生率(RR 0.80;95%CI 0.59 至 1.09;P = 0.16;I² = 0%,QoE 低)无差异。TSA 显示,由于样本量不足,无法检测到观察到的效果,证据尚不确定。
与 DC 相比,EC 可能具有一些优势。然而,TSA 主张谨慎解释结果。
PROSPERO 注册号:CRD42021276557。