Graduate School, Hebei University of Chinese Medicine, 050091 Shijiazhuang, Hebei, China; Department of Anorectal Surgery, The First Affiliated Hospital of Hebei University of Chinese Medicine, 050000 Shijiazhuang, Hebei, China.
Department of Anorectal Surgery, The First Affiliated Hospital of Hebei University of Chinese Medicine, 050000 Shijiazhuang, Hebei, China.
Ann Ital Chir. 2024;95(4):435-447. doi: 10.62713/aic.3511.
Complex anal fistula poses a significant challenge for anorectal surgeons due to its high risks of recurrence and incontinence. A sphincter-preserving procedure named endorectal advancement flap (ERAF) is gradually being applied to clinical practice. Therefore, this meta-analysis aims to evaluate the efficacy and safety of ERAF in managing anal fistula.
We searched PubMed, Embase, Cochrane, and Web of Science databases for relevant manuscripts published from 29 August 2003 to 29 August 2023. Among these studies, outcomes included healing rate, recurrence rate, incontinence rate, and complications. Furthermore, the quality of the included studies was assessed using the Newcastle-Ottawa Scale (NOS) and the Cochrane risk-of-bias tool. The heterogeneity was determined using the chi-squared test and I2 statistic. A random effects model was applied if significant heterogeneity (p < 0.05 and I2 > 50%) was observed. Sensitivity analysis was conducted by excluding studies with a high risk of bias.
Thirty-eight studies were included in the present analysis, involving 1559 participants. The pooled healing rate and recurrence rate of ERAF were 65.5% (95% confidence intervals (CI): 57.6%-73.4%) and 19.6% (95% CI: 14.8%-24.4%), respectively. The pooled incontinence rate was 10.6% (95% CI: 6.0%-15.1%). According to the subgroup analysis, the healing rate, recurrence rate, and incontinence rate of ERAF for fistula associated with inflammatory bowel disease (IBD) were 53.9% (95% CI: 38.1%-69.7%), 32.6% (95% CI: 21.3%-43.8%), and 2.8% (95% CI: 0%-10.6%), respectively. For patients without IBD, the healing rate, recurrence rate, and incontinence rate of ERAF were 70.6% (95% CI: 63.9%-77.4%), 15.7% (95% CI: 9.9%-21.5%), and 16.5% (95% CI: 8.1%-24.9%), respectively. We observed that bleeding, local infection or abscess, flap dehiscence, and haematomas were the common complications, with incidences of 2.2% (95% CI: 0%-4.5%), 9.5% (95% CI: 4.7%-14.4%), 10.4% (95% CI: 0.0%-21.6%), and 12.4% (95% CI: 0%-27.6%), respectively.
ERAF may be an optional treatment for anal fistula from the perspective of effectiveness and safety.
PROSPERO: CRD42023451451.
复杂型肛痿对肛肠外科医生来说是一个巨大的挑战，因为其复发和失禁的风险很高。一种名为经直肠内推进皮瓣（ERAF）的保留括约肌手术方法逐渐应用于临床实践。因此，本荟萃分析旨在评估 ERAF 治疗肛痿的疗效和安全性。
我们检索了从 2003 年 8 月 29 日至 2023 年 8 月 29 日期间发表的 PubMed、Embase、Cochrane 和 Web of Science 数据库中的相关文献。这些研究中的结果包括愈合率、复发率、失禁率和并发症。此外，我们使用纽卡斯尔-渥太华量表（NOS）和 Cochrane 偏倚风险工具评估纳入研究的质量。如果观察到显著的异质性（p<0.05 和 I2>50%），则使用卡方检验和 I2 统计量确定异质性。如果存在显著异质性（p<0.05 和 I2>50%），则采用随机效应模型。敏感性分析通过排除高偏倚风险的研究进行。
本分析共纳入 38 项研究，涉及 1559 名参与者。ERAF 的总体愈合率和复发率分别为 65.5%（95%置信区间（CI）：57.6%-73.4%）和 19.6%（95% CI：14.8%-24.4%）。总体失禁率为 10.6%（95% CI：6.0%-15.1%）。根据亚组分析，ERAF 治疗炎症性肠病（IBD）相关肛痿的愈合率、复发率和失禁率分别为 53.9%（95% CI：38.1%-69.7%）、32.6%（95% CI：21.3%-43.8%）和 2.8%（95% CI：0%-10.6%）。对于没有 IBD 的患者，ERAF 的愈合率、复发率和失禁率分别为 70.6%（95% CI：63.9%-77.4%）、15.7%（95% CI：9.9%-21.5%）和 16.5%（95% CI：8.1%-24.9%）。我们观察到，出血、局部感染或脓肿、皮瓣裂开和血肿是常见的并发症，发生率分别为 2.2%（95% CI：0%-4.5%）、9.5%（95% CI：4.7%-14.4%）、10.4%（95% CI：0.0%-21.6%）和 12.4%（95% CI：0%-27.6%）。
从有效性和安全性的角度来看，ERAF 可能是肛痿治疗的一种选择。
PROSPERO：CRD42023451451.
