Dataset Information

Meta-analysis of transanal versus laparoscopic total mesorectal excision for rectal cancer: a 'New Health Technology' assessment in South Korea.

ABSTRACT:

Purpose

Under the South Korea's unique health insurance structure, any new surgical technology must be evaluated first by the government in order to consider whether that particular technology can be applied to patients for further clinical trials as categorized as 'New Health Technology,' then potentially covered by the insurance sometime later. The aim of this meta-analysis was to assess the safety and efficacy of transanal total mesorectal excision (TaTME) for rectal cancer, activated by the National Evidence-based Healthcare Collaborating Agency (NECA) TaTME committee.

Methods

We systematically searched Ovid-MEDLINE, Ovid-Embase, Cochrane, and Korean databases (from their inception until August 31, 2019) for studies published that compare TaTME with laparoscopic total mesorectal excision (LaTME). End-points included perioperative and pathological outcomes.

Results

Sixteen cohort studies (7 for case-matched studies) were identified, comprising 1,923 patients (938 TaTMEs and 985 LaTMEs). Regarding perioperative outcomes, the conversion rate was significantly lower in TaTME (risk ratio, 0.19; 95% confidence interval, 0.11-0.34; P < 0.001); whereas other perioperative outcomes were similar to LaTME. There were no statistically significant differences in pathological results between the 2 procedures.

Conclusion

Our meta-analysis showed comparable results in preoperative and pathologic outcomes between TaTME and LaTME, and indicated the benefit of TaTME with low conversion. Extensive evaluations of well-designed, multicenter randomized controlled trials are required to come to unequivocal conclusions, but the results showed that TaTME is a potentially beneficial technique in some specific cases. This meta-analysis suggests that TaTME can be performed for rectal cancer patients as a 'New Health Technology' endorsed by NECA in South Korea.

SUBMITTER: Kwon SH

PROVIDER: S-EPMC8424436 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundMinimally invasive total mesorectal excision (MiTME) and transanal total mesorectal excision (TaTME) are popular trends in mid and low rectal cancer. However, there is currently no systematic comparison between MiTME and TaTME of mid and low-rectal cancer. Therefore, we systematically study the perioperative and pathological outcomes of MiTME and TaTME in mid and low rectal cancer.MethodsWe have searched the Embase, Cochrane Library, PubMed, Medline, and Web of Science for articles on MiTME (robotic or laparoscopic total mesorectal excision) and TaTME (transanal total mesorectal excision). We calculated pooled standard mean difference (SMD), relative risk (RR), and 95% confidence intervals (CIs). The protocol for this review has been registered on PROSPERO (CRD42022374141).ResultsThere are 11010 patients including 39 articles. Compared with TaTME, patients who underwent MiTME had no statistical difference in operation time (SMD -0.14; CI -0.31 to 0.33; I2=84.7%, P=0.116), estimated blood loss (SMD 0.05; CI -0.05 to 0.14; I2=48%, P=0.338), postoperative hospital stay (RR 0.08; CI -0.07 to 0.22; I2=0%, P=0.308), over complications (RR 0.98; CI 0.88 to 1.08; I2=25.4%, P=0.644), intraoperative complications (RR 0.94; CI 0.69 to 1.29; I2=31.1%, P=0.712), postoperative complications (RR 0.98; CI 0.87 to 1.11; I2=16.1%, P=0.789), anastomotic stenosis (RR 0.85; CI 0.73 to 0.98; I2=7.4%, P=0.564), wound infection (RR 1.08; CI 0.65 to 1.81; I2=1.9%, P=0.755), circumferential resection margin (RR 1.10; CI 0.91 to 1.34; I2=0%, P=0.322), distal resection margin (RR 1.49; CI 0.73 to 3.05; I2=0%, P=0.272), major low anterior resection syndrome (RR 0.93; CI 0.79 to 1.10; I2=0%, P=0.386), lymph node yield (SMD 0.06; CI -0.04 to 0.17; I2=39.6%, P=0.249), 2-year DFS rate (RR 0.99; CI 0.88 to 1.11; I2=0%, P = 0.816), 2-year OS rate (RR 1.00; CI 0.90 to 1.11; I2=0%, P = 0.969), distant metastasis rate (RR 0.47; CI 0.17 to 1.29; I2=0%, P = 0.143), and local recurrence rate (RR 1.49; CI 0.75 to 2.97; I2=0%, P = 0.250). However, patients who underwent MiTME had fewer anastomotic leak rates (SMD -0.38; CI -0.59 to -0.17; I2=19.0%, P<0.0001).ConclusionThis study comprehensively and systematically evaluated the safety and efficacy of MiTME and TaTME in the treatment of mid to low-rectal cancer through meta-analysis. There is no difference between the two except for patients with MiTME who have a lower anastomotic leakage rate, which provides some evidence-based reference for clinical practice. Of course, in the future, more scientific and rigorous conclusions need to be drawn from multi-center RCT research.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO, identifier CRD42022374141.

Project description:BackgroundTransanal total mesorectal excision has emerged as a potential solution to certain limitations associated with laparoscopic total mesorectal excision in rectal cancer patients. Differences in surgical approaches have raised questions regarding their impact on the risk of postoperative urinary retention, with limited data available from large scale randomized clinical study.ObjectiveTo report incidence of postoperative urinary retention and evaluate the associated risk factors for transanal total mesorectal excision.DesignIn this randomized controlled trial (ClinicalTrials. gov NCT06147492), we retrieved 524 patients who received total mesorectal excision (TME) for stage I-III rectal cancer between June 2019 and April 2022, and the patients were randomly assigned in a 1:1 ratio to undergo either taTME or laTME.PatientsWe enrolled 524 patients who underwent total mesorectal excision for stage I-III rectal cancer between June 2019 and April 2022.Main outcome measuresThe incidence of postoperative urinary retention.ResultsAmong the 524 enrolled patients, 261 were randomized to the laTME group, while 263 were were randomized the taTME group. The median age was 58 years, and 340 participants (64.8 %) were male. Notably, 37 individuals (7.0 %) experienced postoperative urinary retention during the follow-up period, with no significant disparity was observed between the taTME and laTME groups (6.8 % and 7.2 %, respectively, P = 0.98). Risk factors associated with PUR in patients following taTME encompassed early removal of the urinary catheter (P = 0.006), net infusion rate >4.09 ml kg-1.h-1 (P = 0.006), and an age surpassing 65 years (P = 0.0321).LimitationsThe generalizability of the findings outside specialist rectal cancer centers may be limited.ConclusionsTransanal total mesorectal excision was not found to heighten the risk of postoperative urinary retention. Nonetheless, it is advisable removing postoperative catheter beyond the initial day and exercising caution in the administration of intravenous fluids in clinical practice for taTME procedures.

Project description:ImportanceProponents of novel transanal total mesorectal excision (TME) suggest the procedure overcomes the technical and oncologic challenges of conventional approaches for treating rectal cancer. Recently, however, there has been controversy regarding the oncologic safety of the procedure.ObjectiveTo assess the association of transanal TME with the incidence of local recurrence (LR) of cancer and the probability of remaining free of LR during follow-up.Design, setting, and participantsThis multicenter cohort study used data from 8 high-volume rectal cancer academic institutions from across Canada on all consecutive patients with primary rectal cancer treated by transanal TME at the participating centers. The study was conducted between January 2014 and December 2018, and data were analyzed from April 1, 2020, to September 15, 2020.ExposureTransanal TME.Main outcomes and measuresThe incidence of LR was reported as a direct measure of quality of resection. The cumulative probability of LR- and systemic recurrence (SR)-free survival at 36 months was estimated. Local recurrence and SR were defined as radiologic or endoscopic evidence of 1 or more new lesions in or outside the pelvis, respectively, documented during surveillance after the removal of the primary tumor.ResultsOf 608 total patients included in the analysis, 423 (69.6%) were male; the median age was 63 years (interquartile range [IQR], 54-70 years). Local recurrence was identified in 22 patients (3.6%) after a median follow-up of 27 months (IQR, 18-38 months). The median time to LR was 13 months (IQR, 9-19 months). Sixteen of the 22 patients with LR (72.7%) were male, 14 (63.6%) received neoadjuvant chemoradiation, and 12 (54.5%) had American Joint Committee on Cancer stage III disease. Of those with LR, 16 (72.7%) had a negative circumferential radial margin and 20 (90.9%) had a negative distal resection margin, 2 (9.1%) experienced conversion to open surgery, and 15 (68.2%) also developed SR. The probability of LR-free survival at 36 months was 96% (95% CI, 94%-98%). According to the Cox proportional hazards regression model, the hazard ratio of LR was estimated to be 4.2 (95% CI, 2.9-6.2) times higher among patients with a positive circumferential radial margin than among those with a negative circumferential radial margin.Conclusions and relevanceIn this cohort study, transanal TME performed by experienced surgeons was associated with an incidence of LR and SR that is in line with the published literature on open and laparoscopic TME, suggesting that transanal TME may be an acceptable approach for management of rectal cancer.