Transanal total mesorectal excision (TaTME) was introduced in 2009 as a dedicated approach for the treatment of mid-low rectal cancer. We aimed to describe and discuss the learning curve for 121 consecutive TaTME procedures performed by the same team. The primary outcome was the number of operations required to decrease the mean operative time (mOT). The secondary outcomes were the number of operations required to decrease the major complication (MC) rate, the anastomotic leakage (AL) rate, the clinical anastomotic failure rate, and the reoperation rate. A cumulative sum (CUSUM) curve analysis was used to identify the inflection points. As an integrative analysis, Bernoulli CUSUM curves, risk-adjusted CUSUM curves based on the observed-expected outcomes, and CUSUM curves targeting results reported in the literature were created. Seventy-one cases were needed to overcome the OT learning curve sufficiently to reach mastery. The MC and reoperation rates started to decrease after the 54th case and further decreased after the 69th case. The AL rate started to decrease after the 27th case and remained stable at 5–5.1%. The comparison between the different phases of the learning curves confirmed these turning points. TaTME had a learning curve of 71 cases for the mOT, 55–69 cases for MCs and reoperation, and 27 cases for AL. According to our results, attention should be paid during the first part of the learning curve to avoid an increased rate of MCs and AL.

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The learning curve of TaTME for mid-low rectal cancer: a comprehensive analysis from a five-year institutional experience.

Importance Proponents 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 Objective To 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 Participants This 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 Exposure Transanal TME Main Outcomes and Measures The 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 Results Of 608 total patients included in the analysis, 423 (696%) were male; the median age was 63 years (interquartile range [IQR], 54-70 years) Local recurrence was identified in 22 patients (36%) 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 (727%) were male, 14 (636%) received neoadjuvant chemoradiation, and 12 (545%) had American Joint Committee on Cancer stage III disease Of those with LR, 16 (727%) had a negative circumferential radial margin and 20 (909%) had a negative distal resection margin, 2 (91%) experienced conversion to open surgery, and 15 (682%) 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 42 (95% CI, 29-62) times higher among patients with a positive circumferential radial margin than among those with a negative circumferential radial margin Conclusions and Relevance In 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

/pdf/association-of-transanal-total-mesorectal-excision-with-2wellumyv1.pdf

Association of Transanal Total Mesorectal Excision With Local Recurrence of Rectal Cancer.

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.

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

Background in the literature on rectal cancer (RC) surgery many studies have focused on the quality of total mesorectal excision (TME) dissection, while there is a scarcity of comparative data on transection and anastomosis. No anastomosis has so far proved to be superior to any other. The aim of this study was to compare anastomotic leak (AL) rates between conventional laparoscopic double-stapled (DS), transanal total mesorectal excision (TaTME) and Transanal Transection and Single-Stapled anastomosis (TTSS) techniques. Methods consecutive mid-low RC patients undergoing elective laparoscopic TME with stapled anastomosis and protective stoma, by either DS, TaTME or TTSS techniques were retrieved from a prospectively collected database. Results 127 DS; 100 TaTME and 50 TTSS were included. Demographics, distance of the tumor from anal verge and neoadjuvant therapy were comparable. Operative time was longer in TaTME over DS and TTSS (p  Conclusions TTSS strategy is feasible, safe and leads to very low AL rates after TME for RC.

Transanal Transection and Single-Stapled Anastomosis (TTSS): A comparison of anastomotic leak rates with the double-stapled technique and with transanal total mesorectal excision (TaTME) for rectal cancer.

Editor Transanal total mesorectal excision (TaTME) was developed as a surgical solution for a surgical problem. The lower third mesorectal dissection and transection of rectal cancers presents a significant technical challenge, particularly in the narrow android pelvis. It is this subset of male obese patients who record poor oncological outcomes and the cohort that have the most to gain from the TaTME approach. It was therefore logical to attempt part of the dissection from below using a perineal approach with advanced optics and existing dedicated instruments; a modern interpretation of the transanal transabdominal (TATA) procedure developed by Marks in the 1980s1. Although international registry data and select higher volume centres have published oncologically sound data, this has not been universal and the technique is now at a crossroads relating to oncological safety issues among others. Following the Norwegian moratorium on TaTME2, a further report by van Oostendorp and colleagues3 raises oncological concerns relating to the uptake of TaTME. The study focuses on the first 10 patients in each site with dissemination of TaTME proctorship programme across 12 sites. Five of these centres had zero local recurrence, but three had one local recurrence, two centres had two, and one had three local recurrences. Early multifocal local recurrences were observed in eight of 12 cases, and although some clear selection issues were noted in a few of these cases, many of the recurrences appeared technique focused. What is particularly concerning is that these recurrences happened despite an active proctorship programme. According to the IDEAL framework, this 2b exploration study offers a timely warning to closely audit outcomes during this stage of surgical innovation. In Australasia, uptake of TaTME was accompanied by one of the first formal proctorships in the world4. In assessing over 300 TaTME cases, the proctorship group observed a local recurrence rate of 2 per cent at a minimum of 2 years’ follow-up. These reassuring results are in keeping with large studies from the Netherlands and compare favourably with transabdominal techniques for rectal cancer5. The current international COLOR III trial randomizes patients to TaTME or laparoscopic approaches and should inform us of the long term outcomes on a larger scale. The heterogeneous outcomes reported from TaTME series suggest that selection and technique are crucial determinants in outcome. It also appears that the influence of the learning curve on these outcomes can be significant. Although the Australasian experience to date suggests acceptable oncological outcomes can be achieved if the learning curve is managed within a structured training and proctoring programme, van Oostendorp et al.’s study shows this is not universal. Further evidence from longer term follow-up and RCTs regarding oncological outcomes will be needed to help decide the role of TaTME in managing rectal cancer. However, it is already clear that training and dissemination in the TaTME technique will require careful monitoring and evaluation. Consideration may need to be given to enhancing training beyond short courses, perhaps with extended proctorships or dedicated fellowships including TaTME as a focus.

https://bjssjournals.onlinelibrary.wiley.com/doi/pdf/10.1002/bjs.11753

Locoregional recurrences after transanal total mesorectal excision of rectal cancer during the exploration phase.

Background: Transanal total mesorectal excision (TaTME) has been proposed as an approach in patients with mid and low rectal cancer. The TaTME procedure has been introduced in the Netherlands in a structured training pathway, including proctoring. This study evaluated the local recurrence rate during the implementation phase of TaTME. Methods: Oncological outcomes of the first ten TaTME procedures in each of 12 participating centres were collected as part of an external audit of procedure implementation. Data collected from a cohort of patients treated over a prolonged period in four centres were also collected to analyse learning curve effects. The primary outcome was the presence of locoregional recurrence. Results: The implementation cohort of 120 patients had a median follow up of 21·9 months. Short-term outcomes included a positive circumferential resection margin rate of 5·0 per cent and anastomotic leakage rate of 17 per cent. The overall local recurrence rate in the implementation cohort was 10·0 per cent (12 of 120), with a mean(s.d.) interval to recurrence of 15·2(7·0) months. Multifocal local recurrence was present in eight of 12 patients. In the prolonged cohort (266 patients), the overall recurrence rate was 5·6 per cent (4·0 per cent after excluding the first 10 procedures at each centre). Conclusion: TaTME was associated with a multifocal local recurrence rate that may be related to suboptimal execution rather than the technique itself. Prolonged proctoring, optimization of the technique to avoid spillage, and quality control is recommended.

https://bjssjournals.onlinelibrary.wiley.com/doi/pdf/10.1002/bjs.11525

H.J. Bonjer

Papers

Locoregional recurrences after transanal total mesorectal excision of rectal cancer during implementation.