Dataset Information

The learning curve of transanal total mesorectal excision for rectal cancer is associated with local recurrence: results from a multicentre external audit.

ABSTRACT:

Aim

Transanal total mesorectal excision (TaTME) has been suggested as a potential solution for the resection of challenging mid and low rectal cancer. This relatively complex procedure has been implemented in many centres over the last years, despite the absence of long-term safety data. Recently, concern has arisen because of an increase in local recurrence in the implementation phase. The aim of this study was to assess the correlation between accumulated experience and local recurrences.

Method

An independent clinical researcher performed an external audit of consecutive series of all TaTME procedures in six centres in the Netherlands. Kaplan-Meier estimated local recurrence rates were calculated and multivariate Cox proportional hazards regression analysis performed to assess risk factors for local recurrence. Primary outcome was the local recurrence rate in the initial implementation (cases 1-10), continued adoption (cases 11-40) and prolonged experience (case 41 onward).

Results

Six hundred and twenty-four consecutive patients underwent TaTME for rectal cancer with a median follow-up of 27 months (range 1-82 months). The estimated 2- and 3-year local recurrence rates were 4.6% and 6.6%, respectively. Cox proportional hazards regression revealed procedural experience to be an independent factor in multivariate analysis next to advanced stage (ycMRF+, pT3-4, pN+) and pelvic sepsis. Corrected analysis projected the 3-year local recurrence rates to be 9.7%, 3.3% and 3.5% for the implementation, continued adoption and prolonged experience cohorts, respectively.

Conclusion

This multicentre study shows a high local recurrence rate (12.5%) after implementation of TaTME which lowers to an acceptable rate (3.4%) when experience increases. Therefore, intensified proctoring and further precautions must be implemented to reduce the unacceptably high risk of local recurrence at units starting this technique.

SUBMITTER: Van Oostendorp SE

PROVIDER: S-EPMC8453958 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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.

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 TME (taTME) combines abdominal and transanal dissection to facilitate sphincter preservation in patients with low rectal tumors. Few phase II/III trials report long-term oncologic and functional results. We report early results from a North American prospective multicenter phase II trial of taTME (NCT03144765).Methods100 patients with stage I-III rectal adenocarcinoma located ≤ 10 cm from the anal verge (AV) were enrolled across 11 centers. Primary and secondary endpoints were TME quality, pathologic outcomes, 30-day and 90-day outcomes, and stoma closure rate. Univariable regression analysis was performed to assess risk factors for incomplete TME and anastomotic complications.ResultsBetween September 2017 and April 2022, 70 males and 30 females with median age of 58 (IQR 49-62) years and BMI 27.8 (IQR 23.9-31.8) kg/m2 underwent 2-team taTME for tumors located a median 5.8 (IQR 4.5-7.0) cm from the AV. Neoadjuvant radiotherapy was completed in 69%. Intersphincteric resection was performed in 36% and all patients were diverted. Intraoperative complications occurred in 8% including 3 organ injuries, 2 abdominal and 1 transanal conversion. The 30-day and 90-day morbidity rates were 49% (Clavien-Dindo (CD) ≥ 3 in 28.6%) and 56% (CD ≥ 3 in 30.4% including 1 mortality), respectively. Anastomotic complications were reported in 18% including 10% diagnosed within 30 days. Higher anastomotic risk was noted among males (p = 0.05). At a median follow-up of 5 (IQR 3.1-7.4) months, 98% of stomas were closed. TME grade was complete or near complete in 90%, with positive margins in 2 cases (3%). Risk factors for incomplete TME were ASA ≥ 3 (p = 0.01), increased time between NRT and surgery (p = 0.03), and higher operative blood loss (p = 0.003).ConclusionWhen performed at expert centers, 2-team taTME in patients with low rectal tumors is safe with low conversion rates and high stoma closure rate. Mid-term results will further evaluate oncologic and functional outcomes.