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统计、临床、方法学评估经肛门全直肠系膜切除术治疗直肠癌后的局部复发:系统评价。

Statistical, Clinical, Methodological Evaluation of Local Recurrence Following Transanal Total Mesorectal Excision for Rectal Cancer: A Systematic Review.

机构信息

Department of Gastrointestinal Surgery, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.

Section of Colorectal Surgery, Department of Surgery, Westchester Medical Center, New York Medical College, Valhalla, New York.

出版信息

Dis Colon Rectum. 2021 Jul 1;64(7):899-914. doi: 10.1097/DCR.0000000000002110.

Abstract

BACKGROUND

A recent Norwegian moratorium challenged the status quo of transanal total mesorectal excision for rectal cancer by reporting increased early multifocal local recurrences.

OBJECTIVE

The aim of this systematic review and meta-analysis was to evaluate the local recurrence rates following transanal total mesorectal excision as well as to assess statistical, clinical, and methodological bias in reports published to date.

DATA SOURCES

The PubMed and MEDLINE (via Ovid) databases were systematically searched.

STUDY SELECTION

Descriptive or comparative studies reporting rates of local recurrence at a median follow-up of 6 months (or more) after transanal total mesorectal excision were included.

INTERVENTIONS

Patients underwent transanal total mesorectal excision.

MAIN OUTCOME MEASURES

Local recurrence was any recurrence located in the pelvic surgery site. The untransformed proportion method of 1-arm meta-analysis was utilized. Untransformed percent proportion with 95% confidence interval was reported. Ad hoc meta-regression with the Omnibus test was utilized to assess risk factors for local recurrence. Among-study heterogeneity was evaluated: statistically by I2 and τ2, clinically by summary tables, and methodologically by a 33-item questionnaire.

RESULTS

Twenty-nine studies totaling 2906 patients were included. The pooled rate of local recurrence was 3.4% (2.7%-4.0%) at an average of 20.1 months with low statistical heterogeneity (I2 = 0%). Meta-regression yielded no correlation between complete total mesorectal excision quality (p = 0.855), circumferential resection margin (p = 0.268), distal margin (p = 0.886), and local recurrence rates. Clinical heterogeneity was substantial. Methodological heterogeneity was linked to the excitement of novelty, loss aversion, reactivity to criticism, indication for transanal total mesorectal excision, nonprobability sampling, circular reasoning, misclassification, inadequate follow-up, reporting bias, conflict of interest, and self-licensing.

LIMITATIONS

The studies included had an observational design and limited sample and follow-up.

CONCLUSION

This systematic review found a pooled rate of local recurrence of 3.4% at 20 months. However, given the substantial clinical and methodological heterogeneity across the studies, the evidence for or against transanal total mesorectal excision is inconclusive at this time.

摘要

背景

最近挪威的一项暂停令对经肛门全直肠系膜切除术治疗直肠癌的现状提出了挑战,该研究报告称早期局部多灶复发率增加。

目的

本系统评价和荟萃分析旨在评估经肛门全直肠系膜切除术的局部复发率,并评估迄今为止发表的报告中的统计、临床和方法学偏倚。

数据来源

系统检索 PubMed 和 MEDLINE(通过 Ovid)数据库。

研究选择

纳入描述性或比较研究,报告经肛门全直肠系膜切除术中位随访 6 个月(或更长时间)后的局部复发率。

干预措施

患者接受经肛门全直肠系膜切除术。

主要观察指标

局部复发是指位于盆腔手术部位的任何复发。采用 1 臂meta 分析的未转换比例法。报告未经转换的百分比及其 95%置信区间。采用 Omnibus 检验的 ad hoc 荟萃回归分析用于评估局部复发的危险因素。评估研究间异质性:统计学上采用 I2 和τ2,临床评估采用汇总表,方法学评估采用 33 项问卷。

结果

共纳入 29 项研究,总计 2906 例患者。平均 20.1 个月时,局部复发率为 3.4%(2.7%-4.0%),统计异质性低(I2 = 0%)。荟萃回归分析未发现完全直肠系膜切除质量(p = 0.855)、环周切缘(p = 0.268)、远端切缘(p = 0.886)与局部复发率之间存在相关性。临床异质性较大。方法学异质性与新奇的兴奋、损失厌恶、对批评的反应、经肛门全直肠系膜切除术的适应证、非概率抽样、循环推理、分类错误、随访不充分、报告偏倚、利益冲突和自我授权有关。

局限性

纳入的研究为观察性设计,样本量和随访时间有限。

结论

本系统评价发现,20 个月时的局部复发率为 3.4%。然而,鉴于研究之间存在显著的临床和方法学异质性,目前尚不能确定经肛门全直肠系膜切除术的利弊。

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