Department of Anorectal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Anorectal Disease Institute of Shuguang Hospital, Shanghai, China.
PLoS One. 2021 May 13;16(5):e0251460. doi: 10.1371/journal.pone.0251460. eCollection 2021.
A high prevalence of cryptoglandular and Crohn's perianal fistulas has been reported worldwide, and several surgical options are available for the management of anal fistula, with varying clinical efficacy. However, currently, the available evidence for the effectiveness of these surgical approaches are lacking and of concern in terms of the credibility and strength. The purpose of this study is to evaluate the credibility of the published systematic reviews and meta-analyses that assess the efficacy and safety of the surgical options for cryptoglandular and Crohn's perianal fistulas through an umbrella review.
A systematic search in PubMed, Embase and Cochrane library will be performed from inception to December 2020 without any language restriction. We will include systematic reviews and meta-analyses that investigate the efficacy and safety of surgical approaches in the management of cryptoglandular and Crohn's perianal fistulas. Two reviewers will independently screen search results through reading the titles or abstracts. Relevant information will be extracted from each eligible systematic review or meta-analysis. Based on random effects model summary estimates along with their p values, 95% prediction intervals, between-study heterogeneity, small-study effects and excess significance, we will classify the evidence from convincing (class I) to weak (class IV). Findings will be summarized using quantitative synthesis combined with a narrative approach. Cryptoglandular and Crohn's perianal fistulas will be summarized separately. Two authors will independently perform the literature search, data extraction, and quality assessment of each included systematic review and meta-analysis. Any unresolved conflicts or doubts will be resolved by discussion or by consulting a senior author. The risk of bias of the systematic reviews will be assessed using a 16-item Assessment of Multiple Systematic Reviews 2 (AMSTAR2) checklist. The strength of evidence for the included systematic reviews will be classified as "high", "moderate", "low", or "critically low" quality.
Ethics approval is not required as we will collect data from the published systematic reviews and meta-analyses without using individual patient data. The results of this umbrella review will be published in a peer-reviewed journal and will be presented at an anorectal disease conference.
CRD42020200754.
全球范围内报道的肛隐窝和克罗恩病性肛周瘘的患病率较高，针对肛门瘘的治疗有多种手术选择，其临床疗效也各有不同。然而，目前这些手术方法的有效性证据不足，且其可信度和强度令人担忧。本研究旨在通过伞状评价评估评估肛隐窝和克罗恩病性肛周瘘手术治疗方法有效性和安全性的已发表系统评价和荟萃分析的可信度。
从建库到 2020 年 12 月，我们将在 PubMed、Embase 和 Cochrane 图书馆中进行系统检索，不限制任何语言。我们将纳入评估肛隐窝和克罗恩病性肛周瘘手术治疗方法的疗效和安全性的系统评价和荟萃分析。两位评审员将独立通过阅读标题或摘要筛选检索结果。将从每项合格的系统评价或荟萃分析中提取相关信息。我们将根据随机效应模型汇总估计值及其 p 值、95%预测区间、研究间异质性、小样本研究效应和过度显著性，将证据分为有说服力（I 级）到弱（IV 级）。我们将使用定量合成结合叙述方法总结发现。肛隐窝和克罗恩病性肛周瘘将分别进行总结。两位作者将独立进行文献检索、数据提取和纳入的每个系统评价和荟萃分析的质量评估。任何未解决的冲突或疑虑将通过讨论或咨询资深作者解决。我们将使用 16 项评估多项系统评价 2（AMSTAR2）检查表评估系统评价的偏倚风险。纳入系统评价的证据强度将分为“高”、“中”、“低”或“极低”质量。
由于我们将从已发表的系统评价和荟萃分析中收集数据，而不使用个体患者数据，因此不需要伦理批准。该伞状评价的结果将发表在同行评议的期刊上，并将在肛门直肠疾病会议上展示。
PROSPERO 注册号：CRD42020200754。
