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

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.