Department of Obstetrics and Gynaecology, Croydon University Hospital NHS Trust, Croydon, Netherlands.
Department of Radiology, Croydon University Hospital, Croydon, UK.
Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD011482. doi: 10.1002/14651858.CD011482.pub2.
Obstructed defaecation syndrome (ODS) is difficulty in evacuating stools, requiring straining efforts at defaecation, having the sensation of incomplete evacuation, or the need to manually assist defaecation. This is due to a physical blockage of the faecal stream during defaecation attempts, caused by rectocele, enterocele, intussusception, anismus or pelvic floor descent. Evacuation proctography (EP) is the most common imaging technique for diagnosis of posterior pelvic floor disorders. It has been regarded as the reference standard because of extensive experience, although it has been proven not to have perfect accuracy. Moreover, EP is invasive, embarrassing and uses ionising radiation. Alternative imaging techniques addressing these issues have been developed and assessed for their accuracy. Because of varying results, leading to a lack of consensus, a systematic review and meta-analysis of the literature are required.
To determine the diagnostic test accuracy of EP, dynamic magnetic resonance imaging (MRI) and pelvic floor ultrasound for the detection of posterior pelvic floor disorders in women with ODS, using latent class analysis in the absence of a reference standard, and to assess whether MRI or ultrasound could replace EP. The secondary objective was to investigate differences in diagnostic test accuracy in relation to the use of rectal contrast, evacuation phase, patient position and cut-off values, which could influence test outcome.
We ran an electronic search on 18 December 2019 in the Cochrane Library, MEDLINE, Embase, SCI, CINAHL and CPCI. Reference list, Google scholar. We also searched WHO ICTRP and clinicaltrials.gov for eligible articles. Two review authors conducted title and abstract screening and full-text assessment, resolving disagreements with a third review author.
Diagnostic test accuracy and cohort studies were eligible for inclusion if they evaluated the test accuracy of EP, and MRI or pelvic floor ultrasound, or both, for the detection of posterior pelvic floor disorders in women with ODS. We excluded case-control studies. If studies partially met the inclusion criteria, we contacted the authors for additional information.
Two review authors performed data extraction, including study characteristics, 'Risk-of-bias' assessment, sources of heterogeneity and test accuracy results. We excluded studies if test accuracy data could not be retrieved despite all efforts. We performed meta-analysis using Bayesian hierarchical latent class analysis. For the index test to qualify as a replacement test for EP, both sensitivity and specificity should be similar or higher than the historic reference standard (EP), and for a triage test either specificity or sensitivity should be similar or higher. We conducted heterogeneity analysis assessing the effect of different test conditions on test accuracy. We ran sensitivity analyses by excluding studies with high risk of bias, with concerns about applicability, or those published before 2010. We assessed the overall quality of evidence (QoE) according to GRADE.
Thirty-nine studies covering 2483 participants were included into the meta-analyses. We produced pooled estimates of sensitivity and specificity for all index tests for each target condition. Findings of the sensitivity analyses were consistent with the main analysis. Sensitivity of EP for diagnosis of rectocele was 98% (credible interval (CrI)94%-99%), enterocele 91%(CrI 83%-97%), intussusception 89%(CrI 79%-96%) and pelvic floor descent 98%(CrI 93%-100%); specificity for enterocele was 96%(CrI 93%-99%), intussusception 92%(CrI 86%-97%) and anismus 97%(CrI 94%-99%), all with high QoE. Moderate to low QoE showed a sensitivity for anismus of 80%(CrI 63%-94%), and specificity for rectocele of 78%(CrI 63%-90%) and pelvic floor descent 83%(CrI 59%-96%). Specificity of MRI for diagnosis of rectocele was 90% (CrI 79%-97%), enterocele 99% (CrI 96%-100%) and intussusception 97% (CrI 88%-100%), meeting the criteria for a triage test with high QoE. MRI did not meet the criteria to replace EP. Heterogeneity analysis showed that sensitivity of MRI performed with evacuation phase was higher than without for rectocele (94%, CrI 87%-98%) versus 65%, CrI 52% to 89%, and enterocele (87%, CrI 74%-95% versus 62%, CrI 51%-88%), and sensitivity of MRI without evacuation phase was significantly lower than EP. Specificity of transperineal ultrasound (TPUS) for diagnosis of rectocele was 89% (CrI 81%-96%), enterocele 98% (CrI 95%-100%) and intussusception 96% (CrI 91%-99%); sensitivity for anismus was 92% (CrI 72%-98%), meeting the criteria for a triage test with high QoE. TPUS did not meet the criteria to replace EP. Heterogeneity analysis showed that sensitivity of TPUS performed with rectal contrast was not significantly higher than without for rectocele(92%, CrI 69%-99% versus 81%, CrI 58%-95%), enterocele (90%, CrI 71%-99% versus 67%, CrI 51%-90%) and intussusception (90%, CrI 69%-98% versus 61%, CrI 51%-86%), and was lower than EP. Specificity of endovaginal ultrasound (EVUS) for diagnosis of rectocele was 76% (CrI 54%-93%), enterocele 97% (CrI 80%-99%) and intussusception 93% (CrI 72%-99%); sensitivity for anismus was 84% (CrI 59%-96%), meeting the criteria for a triage test with very low to moderate QoE. EVUS did not meet the criteria to replace EP. Specificity of dynamic anal endosonography (DAE) for diagnosis of rectocele was 88% (CrI 62%-99%), enterocele 97% (CrI 75%-100%) and intussusception 93% (CrI 65%-99%), meeting the criteria for a triage test with very low to moderate QoE. DAE did not meet the criteria to replace EP. Echodefaecography (EDF) had a sensitivity of 89% (CrI 65%-98%) and specificity of 92% (CrI 72%-99%) for intussusception, meeting the criteria to replace EP but with very low QoE. Specificity of EDF for diagnosis of rectocele was 89% (CrI 60%-99%) and for enterocele 97% (CrI 87%-100%); sensitivity for anismus was 87% (CrI 72%-96%), meeting the criteria for a triage test with low to very low QoE.
AUTHORS' CONCLUSIONS: In a population of women with symptoms of ODS, none of the imaging techniques met the criteria to replace EP. MRI and TPUS met the criteria of a triage test, as a positive test confirms diagnosis of rectocele, enterocele and intussusception, and a negative test rules out diagnosis of anismus. An evacuation phase increased sensitivity of MRI. Rectal contrast did not increase sensitivity of TPUS. QoE of EVUS, DAE and EDF was too low to draw conclusions. More well-designed studies are required to define their role in the diagnostic pathway of ODS.
排便困难综合征(ODS)是指排便时费力、有不完全排空感或需要手动协助排便的困难。这是由于排便尝试时粪便流的物理阻塞,由直肠前膨出、乙状结肠疝、套叠、肛门失弛缓症或盆底下降引起。排粪造影(EP)是诊断后盆腔底功能障碍的最常用成像技术。它被认为是参考标准,因为有广泛的经验,尽管已经证明它的准确性并不完美。此外,EP 具有侵入性、尴尬和使用电离辐射。已经开发并评估了替代成像技术以解决这些问题,以评估其准确性。由于结果不一致,因此需要进行系统评价和荟萃分析。
使用潜在类别分析,在没有参考标准的情况下,确定 EP、磁共振成像(MRI)和经会阴超声对 ODS 女性后盆腔底功能障碍的检测的诊断测试准确性,并评估 MRI 或超声是否可以替代 EP。次要目的是研究使用直肠对比剂、排粪期、患者体位和截断值等因素对诊断测试准确性的影响,这些因素可能会影响测试结果。
我们于 2019 年 12 月 18 日在 Cochrane 图书馆、MEDLINE、Embase、SCI、CINAHL 和 CPCI 上进行了电子搜索。还检索了世卫组织 ICTRP 和临床试验.gov 以获取合格文章。两名综述作者进行了标题和摘要筛选以及全文评估,并通过第三名综述作者解决了分歧。
如果评估了 EP 以及 MRI 或经会阴超声(或两者)对 ODS 女性后盆腔底功能障碍的检测的诊断测试准确性,则包括诊断测试准确性和队列研究。我们排除了病例对照研究。如果研究部分符合纳入标准,我们会联系作者以获取更多信息。
两名综述作者进行了数据提取,包括研究特征、“风险偏倚”评估、异质性来源和测试准确性结果。如果尽管做出了所有努力,但仍无法检索到测试准确性数据,则排除研究。我们使用贝叶斯分层潜在类别分析进行荟萃分析。如果替代测试的敏感性和特异性与历史参考标准(EP)相似或更高,并且对于分诊测试,特异性或敏感性相似或更高,则该索引测试有资格成为 EP 的替代测试。我们进行了异质性分析,评估了不同测试条件对测试准确性的影响。我们通过排除敏感性分析中存在高偏倚风险、适用性问题或发表于 2010 年之前的研究,来进行敏感性分析。我们根据 GRADE 评估整体证据质量(QoE)。
纳入了 39 项研究,涵盖了 2483 名参与者。我们为每个目标条件的所有索引测试生成了敏感性和特异性的汇总估计值。敏感性分析的结果与主要分析一致。EP 对直肠前膨出的诊断敏感性为 98%(可信区间 94%-99%),乙状结肠疝为 91%(可信区间 83%-97%),套叠为 89%(可信区间 79%-96%),盆底下降为 98%(可信区间 93%-100%);乙状结肠疝的特异性为 96%(可信区间 93%-99%),套叠为 92%(可信区间 86%-97%),肛门失弛缓症为 97%(可信区间 94%-99%),所有这些都具有较高的 QoE。中度至低度 QoE 显示肛门失弛缓症的敏感性为 80%(可信区间 63%-94%),直肠前膨出的特异性为 78%(可信区间 63%-90%)和盆底下降的特异性为 83%(可信区间 59%-96%)。MRI 对直肠前膨出的诊断特异性为 90%(可信区间 79%-97%),乙状结肠疝为 99%(可信区间 96%-100%),套叠为 97%(可信区间 88%-100%),符合高 QoE 的分诊测试标准。MRI 不符合替代 EP 的标准。异质性分析显示,在有排粪期和没有排粪期的情况下,MRI 的敏感性分别为直肠前膨出 94%(可信区间 87%-98%)比 65%(可信区间 52%-89%),乙状结肠疝 87%(可信区间 74%-95%)比 62%(可信区间 61%-88%),以及没有排粪期的敏感性明显低于 EP。经会阴超声(TPUS)对直肠前膨出的诊断特异性为 89%(可信区间 81%-96%),乙状结肠疝为 98%(可信区间 95%-100%),套叠为 96%(可信区间 91%-99%);肛门失弛缓症的敏感性为 92%(可信区间 72%-98%),符合高 QoE 的分诊测试标准。TPUS 不符合替代 EP 的标准。异质性分析显示,在有直肠对比剂和没有直肠对比剂的情况下,TPUS 的敏感性分别为直肠前膨出 92%(可信区间 69%-99%)比 81%(可信区间 58%-95%),乙状结肠疝 90%(可信区间 71%-99%)比 67%(可信区间 51%-90%),套叠 90%(可信区间 69%-98%)比 61%(可信区间 51%-86%),并且明显低于 EP。EVUS 对直肠前膨出的诊断特异性为 76%(可信区间 54%-93%),乙状结肠疝为 97%(可信区间 80%-99%),套叠为 93%(可信区间 72%-99%);肛门失弛缓症的敏感性为 84%(可信区间 59%-96%),符合低至中度 QoE 的分诊测试标准。EVUS 不符合替代 EP 的标准。动态肛门内超声(DAE)对直肠前膨出的诊断特异性为 88%(可信区间 62%-99%),乙状结肠疝为 97%(可信区间 75%-100%),套叠为 93%(可信区间 65%-99%),符合低至中度 QoE 的分诊测试标准。DAE 不符合替代 EP 的标准。经阴道超声(EDF)对套叠的敏感性为 89%(可信区间 65%-98%),特异性为 92%(可信区间 72%-99%),符合替代 EP 的标准,但 QoE 非常低。EDF 对直肠前膨出的特异性为 89%(可信区间 60%-99%),对乙状结肠疝的特异性为 97%(可信区间 87%-100%);肛门失弛缓症的敏感性为 87%(可信区间 72%-96%),符合低至中度 QoE 的分诊测试标准。
在有 ODS 症状的女性人群中,没有任何一种成像技术符合替代 EP 的标准。MRI 和 TPUS 符合分诊测试的标准,因为阳性测试可确认直肠前膨出、乙状结肠疝和套叠的诊断,而阴性测试可排除肛门失弛缓症的诊断。排粪期增加了 MRI 的敏感性。直肠对比剂未增加 TPUS 的敏感性。EVF、DAE 和 EDF 的 QoE 太低,无法得出结论。需要更多设计良好的研究来确定它们在 ODS 诊断途径中的作用。