2025 EAES／ESCP／ESGAR临床实践指南：经肛全直肠系膜切除术治疗直肠癌（更新版）

Abstract

Background The EAES released guidelines on the role of taTME in the management of rectal cancer in 2022.

Objective To develop updated, evidence-informed recommendations to support clinicians involved in the management of taTME; to provide guidance for hospital managers, policymakers, and patients with low- and mid-rectal cancers.

Methods We performed a systematic review to identify randomized trials and matched nonrandomized studies comparing transanal total mesorectal excision (taTME) to laparoscopic TME (laTME) or robotic TME (roTME) in patients with low- and mid-rectal cancer. A panel of general and colorectal surgeons, a radiologist, a pathologist, and patient partners appraised the certainty of the evidence using GRADE. The panel developed recommendations using an evidence-to-decision framework during an in-person consensus meeting. We applied a Delphi survey to establish consensus.

Results The panel recommends taTME over laTME in patients with low- and selected mid-rectal cancers when access to surgeons with expertise in performing taTME in high-volume rectal cancer centers is available (strong recommendation). This recommendation applies to patients eligible for sphincter preservation who are at high risk for conversion to abdomin-operineal resection, including male gender with BMI > 30 kg/m$^{2}$. The recommendation is supported by a reduction in 30-day major complications and disease recurrence at 2 years with taTME compared to laTME. When access to a surgeon with expertise in performing taTME is not available, the panel recommends against taTME over laTME (strong recommendation). Further, the panel suggests roTME as an alternative to taTME in patients with low- and selected mid-rectal cancers when access to surgeons with expertise in performing taTME is not available (conditional recommendation).

Conclusion We provide evidence-informed guidance on the role of taTME in the surgical management of patients with low- and mid-rectal cancers. Patients and surgeons should exercise shared-decision making to apply patient-tailored decisions when considering treatment options.

Keywords taTME · Transanal TME · laTME · Laparoscopic TME · roTME · Robotic TME · Rectal cancer

Total mesorectal excision (TME) was introduced by Richard Heald in 1978 to remove rectal cancer en bloc with its primary lymphovascular drainage. This approach aims to prevent the spread of rectal cancer by addressing lymphatic and venous dissemination [1, 2]. Since then, TME has been considered the gold standard of care for curative

rectal cancer resection, yielding a reduction in recurrence and improving long-term survival [2]. Modern approaches to achieving TME include laparoscopic TME (laTME) to improve short-term outcomes [2], but rectal dissection and visualization of the mesorectal plane remain challenging, especially in males, obese patients, or patients with low-lying or advanced tumors [3].

Robotic TME (roTME) was introduced to address these challenges [2], employing a robotic system to improve visualization and maneuverability in the low pelvis to facilitate pelvic dissection [2]. However, roTME is associated with a significant learning curve [4], while access to robotic platforms remains limited in many centers [5]. Transanal

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TME (taTME) was developed as an alternative approach to improving low pelvic dissection by allowing direct access to the distal third of the rectum and mesorectum through the anus to obtain optimal visualization of the distal resection margin and to overcome cases with difficult pelvic dissection [2, 6]. Still, taTME is associated with a significant learning curve [4, 7], while there is debate regarding the efficacy and safety of the technique [8].

The EAES released a conditional recommendation in favor of taTME over laTME and roTME in 2022 with a planned guideline update in 2025 [9]. As new evidence is available, we performed an updated evidence synthesis and developed contemporary guideline recommendations on the role of taTME in the management of patients with low- and mid-rectal cancers. This guideline provides evidence-informed recommendations to support clinicians involved in the management of taTME and provides guidance for hospital managers, policymakers, and patients with low- and mid-rectal cancers. The objective is to mitigate complications associated with the treatment of rectal cancer and improve oncological outcomes, while optimizing patient experience and health-related quality of life.

Methods

Health questions

Our guideline investigated the following questions:

1. Should patients receive taTME or laparoscopic TME (laTME) for the surgical treatment of patients with low- or mid-rectal cancers? 2. Should patients receive taTME or robotic TME (roTME) for the surgical treatment of patients with low- or mid-rectal cancers?

Subgroups of interest included the use of these techniques in patients that have received neoadjuvant therapy (including the use of chemotherapy or radiation) versus upfront resection, and patients with low- versus mid-rectal cancers. Our hypothesis was that the effect of taTME on patient-important outcomes would be diminished among patients undergoing neoadjuvant therapy versus upfront resection but augmented among those with low- versus mid-rectal cancer.

Target users

This guideline is meant to support colorectal, endoscopic, and general surgeons, radiologists, pathologists, other healthcare professionals, hospital managers, policymakers, and patients in the workup and management of patients with low- and mid-rectal cancers. This manuscript reflects

surgeons' and patients' perspectives through patient involvement in the guideline panel, the use of utility values, and consideration for patient values and preferences during the EiD framework. We provide a separate version of the guide-lain tailored for patients, developed using the paid version of ChatGPT-4o on July 8th, 2025, by providing ChatGPT-4o with an example of a previous guideline and accompanying patient-specific version, followed by requesting for a patient version of this current guideline manuscript (Supplementary File 1). The patient version of this guideline follows standards outlined by the Patient Versions of Guideline extension of the Reporting Tool for Practice Guidelines in Healthcare (RIGHT-PVG) [10]. The chat transcript including all prompts and responses are listed in Supplementary File 2.

Definitions

After thorough discussion by the panel at the synchronous consensus meeting, we identify low- and mid-rectal tumors as follows:

Low-rectal cancer: located 4–8 cm from the anal verge. Mid-rectal cancer: located 8–12 cm from the anal verge.

We reached this definition by reviewing available literature such as guidance from UpDate [11], as well as the experience of colorectal surgeons on the international, multidisciplinary panel.

Guideline development

This guideline was developed in alignment with various standards including the Appraisal of Guidelines for Research and Evaluation in Surgery II Extension for Surgical Guidelines (AGREE-S), Grading of Recommendations, Assessment, Development and Evaluation (GRADE), Guidelines International Network (GIN), Institute of Medicine, and Cochrane Rapid Reviews Methods Group [12–16]. Supplementary File 3 contains the AGREE-S reporting checklist. Guideline development was facilitated using MAGICapp (MAGIC Evidence Ecosystem Foundation, Oslo, Norway). This guideline uses a pragmatic intention-to-treat approach. The steering group developed a protocol a priori [17]. The protocol draft was made publicly available through the EAES website and EAES members were invited through the EAES email newsletter to comment on the content. Amendments to the protocol with justifications are provided below. We registered the guideline in the Guidelines International Network (GIN) International Guidelines Library: https://guidelines.ebmportal.com/eaes-rapid-recommenda

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tion-update-2025-tatme-rectal-cancer-sages-and-escp-participation.

Steering group

The steering group consisted of a colorectal surgeon (AA) and a guideline methodologist in training (BH), supervised by a GIN-certified lead guideline developer and chair (SAA) with vast experience in evidence outreach, synthesis, assessment, and guideline development (INGUIDE certification number: 2022-L3-V1-00014) [18]. All steering group members declared no direct nor indirect conflicts [17]. Figure 1 represents a visual summary of the structure of the guideline development group.

Systematic review group

The guideline methodologist in training also coordinated the systematic review, data collection, and risk of bias assessment, performed by 3 trained systematic reviewers

(DS, YT, AB), as detailed in the linked systematic review [19].

Guideline panel

The guideline panel comprised three general surgeons (DP, DN, RJR) and two colorectal surgeons (AD, MA), all experienced in laTME, with two also performing roTME and three performing taTME. Furthermore, the panel included a radiologist (SG) representing the European Society of Gastrointestinal and Abdominal Radiology (ESGAR), a pathologist (VV), and 2 patient partners (SD, RRI). One patient partner had an abdominoperineal resection 14 years ago for stage III colorectal cancer, and an end colostomy. Furthermore, she has participated in other guideline development projects [20, 21]. The other patient partner underwent upfront resection in the way of a rectosigmoid resection with end colostomy in 2021 six days following her diagnosis. She did not require adjuvant chemoradiation. Both patient partners were ordinary panel members with equal participation and voting rights. We selected participants to represent diverse surgical practices across various regions of Europe,

![graph TD\n A1[Steering group（content chair, methodologist）] --> A2[External advisor]\n A2 --> A3[Panel]\n A2 --> A4[Statistical group]\n A2 --> A5[Systematic review group]\n A2 --> A6[External auditor]\n A3 --> A4\n A3 --> A5\n A4 --> A3\n A5 --> A3\n A6 --> A3\n](1/parseimages/figure282bb5d975b348af999fc63dfdaf1f44_0_9.png) Fig. 1 Guideline Development Group

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different age groups, and both genders while minimizing the risk of intellectual bias related to taTME and roTME. All panel members had voting privileges and participated in the in-person consensus meeting apart from one panel member (VV), who was unable to attend due to personal reasons. This panel member participated in all other relevant tasks for our guideline panel members.

The steering group provided panel members with a short video tutorial outlining the guideline development methodology. All panel members disclosed their conflicts of interest, and their disclosures were reviewed by the guideline methodologist in training and the lead guideline methodologist. They did not identify substantial risks of bias. While a few members reported minor indirect conflicts, these were deemed insignificant and did not compromise the project's validity. Conflict of interest declarations are available for public review in the online appendix [17].

A key opinion leader on the topic participated as external advisor with no voting rights on the direction or the strength of the recommendation (PS). A lead member of GIN participated as external advisor, overseeing the processes and communications, and participated in the in-person consensus meeting (IDF).

Outcome selection & decision thresholds

The steering group drafted a list of potential outcomes by performing a scoping review of recently published trials. Panel members independently assessed the importance of each outcome using the GRADE scale to specify outcomes of interest [22]. Panel members also proposed additional outcomes considered important or critical. Substantial variation was observed among panel evaluations of outcomes. To address this, the steering group shortlisted seven outcomes and discussed their suitability as key outcomes during an in-person meeting. The panel unanimously approved the final selection. To guide the prioritization of outcomes, we placed emphasis on patient-important outcomes, while adhering to

Cochrane guidance in focusing on the most relevant outcomes for patients, clinicians, and policymakers [16].

In addition, the steering group asked panel members to provide their judgments on the utility of each outcome, with 0 being the worst possible health state/death, and 1 the best possible health state. We presented questions such as "What do you consider is the utility value of major postoperative complications (Clavien-Dindo ≥ 3b; e.g., reoperation)?" There was significant variation in responses on several outcomes, and consensus was achieved during the in-person consensus meeting among panel members.

We converted utility values to absolute risk difference thresholds according to the equation:

$$\text{Absolute Risk Difference}=\frac{\text{coefficient}}{1-\text{Utility}}* 1000$$

We used research-informed anchors as coefficients indicating trivial-to-small effect threshold (0.0135), small-to-moderate effect threshold (0.0321), and moderate-to-large effect threshold (0.0625). We obtained absolute risk thresholds for trivial/small, small/moderate, and moderate/ large effects. Additionally, absolute effect differences were converted to coefficients according to the equation: Coef-ficient = Absolute Effect Difference/1000 * (1—Utility).

We aggregated these values (positive and negative). The judgements on the effect sizes of each outcome informed discussions on the evidence-to-decision framework by comparing absolute risk differences to empirically derived absolute risk thresholds, and the net benefit or harm/burden using the aggregate coefficient compared to coefficient thresholds [23].

Panel ratings and considerations pertaining to outcome prioritization are available in the online appendix [17]. Table 1 outlines outcomes and absolute risk difference/ minimally important difference (MID) thresholds.

Table 1 Outcomes, utility values, and decision thresholds

|Outcomes|Utility values|Decision thresholds (n per 1000)||| |---|---|---|---|---| |Outcomes|Utility values|Trivial-small*|Small-moder- ate****|Moderate- large****| |30-day mortality|0|14|32|63| |30-day major complica- tions*|0.3|20|46|90| |Recurrence|0.5|27|65|125| |5-year DFS**|1|135|321|625| |5-year OS***|0.8|68|161|313| |LARS|N/A|5 (scale 0-42)|5 (scale 0-42)|5 (scale 0-42)| |QoL|N/A|0.2 (standardized mean difference)|||

*According to Clavien-Dindo ≥3b | *Disease-free survival | *Overall survival | *Indicates positive or negative difference in number of patients per 1,000, when comparing different interventions

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Systematic review

The methodology applied in the development of the systematic review and meta-analysis is reported in the accompanying publication [19].

GRADE certainty of evidence

We assessed the certainty of the evidence by evaluating the risk of bias across studies, imprecision, inconsistency, indirectness, and publication bias [24, 25]. We followed GRADE guidance by appraising nonrandomized studies using ROB-INS-I and applying the judgement of high certainty of evidence at baseline for each outcome and downgrading as appropriate [26].

We constructed GRADE evidence summary profiles in MAGICapp. We assessed imprecision by interpreting the confidence interval of effect estimates in the context of the empirically derived effect thresholds, as well as the sample size of patients across comparisons [25]. We assessed inconsistency as stated in the data analysis section, as inconsistency could not be explained. We considered the indirectness of comparisons based on the correlation between the population, intervention, comparison, and outcomes (PICO) elements in the present guideline and the PICO elements in the source studies [25].

Evidence-to-decision framework

The steering group provided the guideline panel with GRADE evidence summaries and supporting materials. The meeting began with a detailed presentation of the guideline development methodology and an overview of rectal cancer as well as TME versus taTME. The panel then discussed concerns surrounding the evidence summaries as well as the evidence-to-decision framework and resolved disagreements by consensus. We used the following factors during the evidence-to-decision framework [27]:

$\bullet$ Benefits and harms of the intervention $\bullet$ Certainty of the evidence $\bullet$ Values and preferences of patients and healthcare providers $\bullet$ Resources required $\bullet$ Acceptability of the intervention $\bullet$ Feasibility of implementing the intervention $\bullet$ Equity

Following the consensus meeting, panel members participated in an online voting on the direction and strength of the recommendations and had the opportunity to suggest modifications to existing recommendations according to the GRADE methodology [28]. The external advisor was

not permitted to vote on the final recommendations. We considered consensus as agreement among > 80% of panel members, if after exhaustive deliberations no unanimous consensus was achieved.

Deviations from the protocol

To enhance our panel with the highest-level expertise and foster intersociety collaboration, we invited representatives from ESCP and ESGAR, who contributed panel members to the guideline development group. Additionally, we had recruited two external advisors, though one was unable to participate for personal reasons. Furthermore, we recruited an additional member to the systematic review team to support the other two reviewers. Due to time constraints, the systematic review lead completed risk of bias appraisal for randomized controlled trials. Similarly, we grouped outcomes together for risk of bias appraisal by likeness including 30-day mortality/30-day major complications, LARS/QoL, and 5-year OS/5-year DFS.

Following an introductory panel meeting with an extensive overview of our methodology, panelists voted to prioritize a list of 19 outcomes to select important or critical outcomes of interest for evaluation. Panelists were instructed to provide a range in ratings across outcomes, but the median score across all outcomes was either important or critical. Thus, the steering committee prioritized a list of 7 outcomes, placing emphasis on outcomes of importance to patients while considering the degree of overlap between outcomes. The selection of outcomes was unanimously approved by the panel.

Similarly, the panel rated utility values across all outcomes to generate decision thresholds. The panel was provided with an overview of utility value ratings and were instructed to provide a range of ratings between mortality (0) and survival (1), but all outcomes were rated highly or out of keeping with this scale. Thus, the steering group conferred to generate utility values for each outcome with consideration for the perspective of the average patient. The steering group presented both the shortlist of outcomes and utility values at the in-person consensus meeting. The panel reviewed the outcomes and obtained perspectives from our patient partners and accepted the shortlist of prioritized outcomes. The panel reviewed and approved all utility values with the exception of 5-year DFS and 5-year OS, initially rated as 0.8 and 1, respectively. After discussion and input from patient partners, the panel reached consensus for ratings of 0.8 and 1 for 5-year OS and 5-year DFS, respectively, under the justification that one would prioritize being alive and disease-free as opposed to being alive but potentially with recurrent disease at 5 years.

In the outcomes, 5-year overall survival and 5-year disease-free survival, the data were in the form of [event]/

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[sample size], and not hazard ratio and 95% confidence interval, therefore the odds ratios were calculated in place of hazard ratios.

Results

We found 35 reports on 32 studies (5 randomized control trials and 27 observational studies). The PRISMA 2020 flow-chart, a list of included records, a list of excluded records with reasons, the data extraction sheet, risk of bias assessments per outcome or group of outcomes are provided in the appendix: https://osf.io/6c3gp/?view_only=b1078a0162914d1da45a45310e97ebe7. Demographic characteristics, shown in Table 2, were derived through an aggregate synthesis of data from the collected studies.

Subgroup analyses

No data were found to inform predefined subgroup analyses, and relevant recommendations were informed by indirect evidence from the main analyses.

Evidence synthesis

Summary of findings tables for the comparison of taTME versus laTME and taTME versus roTME are available in Tables 3 and 4, respectively.

Aggregate data showed that patients may experience a reduction in 30-day major complications and disease recurrence at 2 years in patients undergoing taTME compared to laTME (Fig. 2). There were either no significant differences or high uncertainty among outcomes among patients undergoing taTME compared to roTME (Fig. 3). Detailed statistical analyses are available in the appendix [17]. We provide an in-depth overview of the results in our systematic review [19]. Based on anchor-informed utility values, the net coefficient was 0.0575, indicating a moderate effect size in favor of the intervention for the comparison taTME vs. laTME. The certainty of the evidence was very low for the comparison taTME vs. roTME, therefore, we refrained from calculating the net effect coefficient.

|Variable|TaTME|laTME|roTME| |---|---|---|---| |Age (Mean ± SD years)|62.6 ± 14|62.6 ± 14.1|63.2 ± 12.7| |Gender (% Male)|67.3|64.1|63| |BMI (Mean ± SD kg/m²)|24.9 ± 4.4|24.6 ± 4.5|25.1 ± 4.2| |ASA Class (% Patients)|||| |I|39.4|41.9|21| |II|51.8|49.3|63.9| |III|11.5|10.5|15.1| |IV|0.6|0.6|0| |Prior abdominal surgery (% Patients)|15.6|12.5|30.6| |Clinical stage (%)|||| |I|18.9|17.3|40| |II|36.5|38.6|33.5| |III|43.5|44.1|55.8| |IV|6|7|5| |cTNM (%)|||| |cT1|7.6|7.9|30.3| |cT2|17.5|17.3|33.3| |cT3|67.3|64.7|65.7| |cT4|6.8|7.4|9.2| |cN0|52.2|47.7|31.1| |cN1|37.3|44.3|50| |cN2|12.6|22.5|41.7| |Tumor distance to anal verge (Mean ± SD cm)|5.5 ± 1.9|5.8 ± 2.7|5.6 ± 2.6| |Neoadjuvant chemoradiation (%)|37.8|32.5|72.6| |Clear circumferential margin (%)|96.7|95.2|94.3| |Clear distal resection margin (%)|98.9|98.2|99.2| |Lymph node harvest (Mean ± SD)|14.9 ± 12.4|15.9 ± 18.6|14.6 ± 7.8| |Hand-sewn anastomosis (%)|31.2|16.7|28.6|

|Outcome Timeframe|Study results and measurements|Absolute effect estimates|Certainty of the evidence (Quality of evidence)|Summary|| |---|---|---|---|---|---| |Outcome Timeframe|Study results and measurements|laTME|Certainty of the evidence (Quality of evidence)|Summary|taTME| |30-day mortality|Odds ratio: 0.38 (CI 95% 0.16-0.9) Based on data from 3526 participants in 20 studies Follow-up 30 days|1 per 1000|0 per 1000|Moderate Due to serious risk of $bias^{1}$|TaTME probably has little or no difference on 30-day mortality| |30-day major complications|Odds ratio: 0.49 (CI 95% 0.2-1.22) Based on data from 686 participants in 5 studies Follow-up 30 days|90 per 1000|46 per 1000|Low Due to serious risk of bias, Due to serious $imprecision^{2}$|TaTME may decrease 30-day major complications slightly| |Recurrence at 2 years|Odds ratio: 0.71 (CI 95% 0.56-0.9) Based on data from 4583 participants in 12 studies Follow-up 2 years|130 per 1000|96 per 1000|Low Due to serious risk of bias, Due to serious $imprecision^{3}$|TaTME may decrease recurrence at 2 years slightly| |5-year disease-free survival|Odds ratio: 1.18 (CI 95% 1.04-1.35) Based on data from 5108 participants in 12 studies Follow-up 5 years|760 per 1000|789 per 1000|Low Due to serious risk of bias, Due to serious $indirectness^{4}$|TaTME may have little or no difference on 5-year disease-free survival| |5-year overall survival|Odds ratio: 1.4 (CI 95% 1.18-1.66) Based on data from 5144 participants in 12 studies Follow-up 5 years|890 per 1000|919 per 1000|Low Due to serious risk of bias, Due to serious $indirectness^{5}$|TaTME may have little or no difference on 5-year overall survival| |Non-contextualized - Clear CRM|Odds ratio: 1.55 (CI 95% 1.19-2.01) Based on data from 6654 participants in 23 studies|950 per 1000|967 per 1000|Low Due to very serious risk of $bias^{6}$|TaTME may have little or no difference on clear CRM| |Non-contextualized - Clear DRM|Odds ratio: 1.8 (CI 95% 1.02-3.18) Based on data from 5001 participants in 17 studies|980 per 1000|989 per 1000|Low Due to very serious risk of $bias^{7}$|TaTME may have little or no difference on clear DRM| |LARS|Measured by: LARS Score Scale: 0-42 Lower better Based on data from 384 participants in 5 studies|26.02 Mean Difference: MD 3.93 higher (CI 95% 1.28 lower-9.15 higher)|28.90 Mean Difference: MD 3.93 higher (CI 95% 1.28 lower-9.15 higher)|Low Due to serious risk of bias, Due to serious inconsistency, Due to serious $imprecision^{8}$|TaTME may have little or no difference on LARS| |QoL|Measured by: Scale: High better Based on data from 269 participants in 3 studies|51.06 Mean Difference: MD 0.12 higher (CI 95% 0.14 lower-0.39 higher)|53.21 Mean Difference: MD 0.12 higher (CI 95% 0.14 lower-0.39 higher)|Low Due to serious risk of bias, Due to serious $imprecision^{9}$|TaTME may have little or no difference on QoL|

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|Outcome Timeframe|Study results and measurements|Absolute effect estimates|Certainty of the evidence (Quality of evidence)|Summary|| |---|---|---|---|---|---| |Outcome Timeframe|Study results and measurements|laTME|Certainty of the evidence (Quality of evidence)|Summary|taTME| |Non-contextualized - Lymph node harvest|Measured by: Number of lymph nodes: High better Based on data from 5320 participants in 22 studies|15.8 Lymph nodes Mean|16.0 Lymph nodes Mean|Low Due to very serious risk of $bias^{10}$|TaTME may have little or no difference on lymph node harvest| |Non-contextualized - Lymph node harvest|Measured by: Number of lymph nodes: High better Based on data from 5320 participants in 22 studies|Difference: MD 0.1 fewer (CI 95% 0.9 fewer-1.1 more)||||

1 Risk of Bias: serious. Sensitivity analyses comparing studies with low or moderate risk of bias to those with high risk of bias showed similar effect estimates. While most studies were observational and matched, the potential for residual bias remains. Therefore, we downgraded the evidence by one level; Imprecision: no serious. Because the baseline risk is very low, we did not rate down for imprecision (GRADE Guidance 34; 4.3); 2 Risk of Bias: serious. Sensitivity analyses comparing studies with low or moderate risk of bias to those with high risk of bias showed similar effect estimates. While most studies were observational and matched, the potential for residual bias remains. Therefore, we downgraded the evidence by one level; Imprecision: no serious. Because the baseline risk is very low, we did not rate down for imprecision (GRADE Guidance 34; 4.3); 2 Risk of Bias: serious. Sensitivity analyses comparing studies with low or moderate risk of bias to those with high risk of bias showed similar effect estimates. While most studies were observational and matched, the potential for residual bias remains. Therefore, we downgraded the evidence by one level; Imprecision: no serious. Because the baseline risk is very low, we did not rate down for imprecision (GRADE Guidance 34; 4.3); 2 Risk of Bias: serious. Sensitivity analyses comparing studies with low or moderate risk of bias to those with high risk of bias showed similar effect estimates. While most studies were observational and matched, the potential for residual bias remains. Therefore, we downgraded the evidence by one level; Imprecision: no serious. Because the baseline risk is very low, we did not rate down for imprecision (GRADE Guidance 34; 4.3); 2 Risk of Bias: serious. Sensitivity analyses comparing studies with low or moderate risk of bias to those with high risk of bias. This is appreciated in the Funnel plot; 4 Risk of Bias: disses. The study with the greatest weight (Li 2024) at moderate risk of bias. Other with significant contribution to the overall effect estimate: Zheng 2025 with some concerns; deLacy 2020 at serious risk; Alhanafy 2020 at moderate risk; Li 2022 at moderate risk. We downgraded by one level; Indirectness: serious. Most studies report on 3-year follow-up; 5 Risk of Bias: serious. The study with the greatest weight (Li 2024) at moderate risk of bias. Other with significant contribution to the overall effect estimate: Zheng 2025 with some concerns; deLacy 2020 at serious risk; Alhanafy 2020 at moderate risk; Li 2022 at moderate risk. We downgraded by one level; Indirectness: serious. Most studies report on 3-year follow-up; 6 Risk of Bias: very serious. Due to serious risk of bias in cohort studies and potential residual confounding; Imprecision: no serious. Assuming a 5% MID between intervention and comparator; 7 Risk of Bias: very serious. Due to serious risk of bias in cohort studies and potential residual confounding; Imprecision: no serious. Assuming a 5% MID between intervention and comparator; 7 Risk of Bias: very serious. Due to serious risk of bias in cohort studies and potential residual confounding; Imprecision: no serious. Assuming a 5% MID between intervention and comparator; 7 Risk of Bias: very serious. Due to serious risk of bias in cohort studies and potential residual confounding; Imprecision: no serious. Using a 5% MID between intervention and comparator; 7 Risk of Bias: very serious. Using a 5% MID is not a serious risk of bias in cohort studies and potential residual confounding; Imprecision: no serious. Using a 5% MID is not a serious risk of bias in cohort studies and potential residual confounding; Imprecision: no serious. Using a 5% MID is not a serious risk of bias in cohort studies and potential residual confounding; Imprecision: no serious. Using a 5% MID is not a serious risk of bias in cohort studies and potential residual confounding; Imprecision: no serious. Using a 5% MID is not a serious risk of bias in cohort studies and potential residual confounding; Imprecision: no serious. Using a 5% MID is not a serious risk of bias in cohort studies and potential residual confounding; Imprecision: no serious. Using a 5% MID is not a serious risk of bias in cohort studies and potential residual confounding; Imprecision: no serious. Using a 5% MID is not a serious risk of bias in cohort studies and potential residual confounding; Imprecision: no serious. Using a 5% MID is not a serious risk of bias in cohort studies and potential residual confounding; Imprecision: no serious. Using a 5% MID is not a serious risk of bias in cohort studies and potential residual confounding; Imprecision: no serious. Using a 5% MID is not a serious risk of bias in cohort studies and potential residual confounding; Imprecision: no serious. Using a 5% MID is not a serious risk of bias in cohort studies and potential residual confounding; Imprecision: no serious. Using a 5% MID is not a serious risk of bias in cohort studies and potential residual confounding; Imprecision: no serious. Using a 5% MID is not a serious risk of bias in cohort studies and potential residual confounding; Imprecision: no serious. Using a 5% MID is not a serious risk of bias in cohort studies and potential residual confounding; Imprecision: no

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Table 4 Evidence summary table for latME vs. RTME

|Outcome|Sudy results and measurements|Absolute effect estimates|laTME|Certality of the evidence (Quality) of evidence)|Summary| |---|---|---|---|---|---| |Timeframe|096.97% 0.33|100|per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |30-day mortality|096.97% 0.29|84|1990 per 1000|Due to very serious risk risk. Due to very 1000 per 1000 in precision*|We are uncertain whether laTME increases or decrease 30-day mortality| |30-day major complications|096.97% 0.16|84|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |Recurrence at 2 years|096.97% 0.16|84|1990 per 1000|Due to very serious risk of bias. Due to very 1000 per 1000 in precision*|We are uncertain whether laTME increases or decrease 30-day mortality| |5-year overall survival|096.97% 0.24|42|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |5-year centralized - Clear DRM|096.97% 0.17|88|1990 per 1000|Due to very serious risk of bias. Due to very 1000 per 1000 in precision*|We are uncertain whether laTME increases or decrease 30-day mortality| |52.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |53.99% 0.00|096.97% 0.24|88|1990 per 1000|Due to very serious risk of bias. Due to very 1000 per 1000 in precision*|We are uncertain whether laTME increases or decrease 30-day mortality| |54.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |55.99% 0.00|096.97% 0.17|88|1990 per 1000|Due to very serious risk of bias. Due to very 1000 per 1000 in precision*|We are uncertain whether laTME increases or decrease 30-day mortality| |56.99% 0.00|096.97% 0.24|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |57.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |58.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |59.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |58.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |59.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |59.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |59.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |59.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |59.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |59.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |59.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |59.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |59.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |59.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |59.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |59.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |59.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |59.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTME increases or decrease 30-day mortality| |59.99% 0.00|096.97% 0.17|88|1990 per 1000|Very low|We are uncertain whether laTM|

11 Risk of Bias: very serious. Due to insufficient control and confounding variables (serious risk and lim�). We downgradated by 2 levels: Impreciation: 11 Risk of Bias: very serious. Due to insufficient control for confounding variables (serious risk of bias in bias in control studies) for confounding variables (serious risk of bias in bias in control studies) over 2 levels: In 14 Risk of Bias: Vredde with each other. We used calculations from the random interval map minimally with each other. We used calculations from the random interval over 2 levels. Low number of patients; 16 Risk of Bias: very serious. Due to non-reserve inter intervals; 2nd MID under confounding; 2nd MID under confounding; 2nd MID under confounding; 2nd MID under confounding; 2nd MID under confounding; 2nd MID under confounding; 2nd MID under confounding; 2nd MID under confounding; 2nd MID under confounding; 2nd MID under confounding; 2nd MID under confounding; 2nd MID under confounding; 2nd MID under confounding; 2nd MID under confounding; 2nd MID under confounding; 2nd MID under confounding; 2nd MID under co

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Delphi process

The panel reached 100% consensus after the first Delphi round, supporting the recommendations listed in Box 1.

Box 1 Recommendations for the role of TaTME in the treatment of rectal cancer

Recommendations

1. In patients with low- and selected mid-rectal cancers, we recommend taTME over laparoscopic TME when access is available to surgeons with expertise in performing taTME.*

Strong recommendation

*Strong recommendation for taTME over laTME when access is available to surgeons with expertise in performing taTME in high-volume rectal cancer centers in patients with high risk for conversion including male gender with BMI > 30 kg/m2 eligible for sphincter preservation.

2. We recommend against performing taTME over laparoscopic TME in patients with low- and mid-rectal cancers when access to surgeons with expertise in performing taTME is not available.

Strong recommendation

3. In patients with low- and selected mid-rectal cancers, we suggest roTME as an alternative to taTME when access to surgeons with expertise in performing taTME is not available.*

Conditional recommendation

*Conditional recommendation in patients with high risk for conversion including male gender with BMI > 30 kg/m2 eligible for sphincter preservation where access to surgeons with expertise in roTME in high-volume rectal cancer centers is available. This recommendation does not address the comparison between laTME and roTME.

A strong recommendation means that all or almost all properly informed stakeholders (patients, surgeons, allied healthcare professionals) would opt for the recommended course of action, and only in exceptional cases the recommendation may not be followed.

A conditional recommendation means that the majority of stakeholders (patients, surgeons, allied healthcare professionals), if properly informed, would opt for the recommended course of action. However, uncertainty in the evidence and/or variability in patient preferences and surgeon's experience, expertise, and skills may call for joint decision making.

Discussion

Implications for healthcare professionals

Surgeons and trainees must be aware of the relative benefits and harms identified in this guideline update and accompanying evidence synthesis [19]. Surgeons and trainees may pursue the training necessary to gain proficiency in multiple techniques in the treatment of patients with rectal cancers. With respect to taTME, the learning curve is on the order of 40–50 cases [29–32]. Moreover, prospective surgeons aiming to perform taTME must have sufficient case volumes at their institution to maintain their proficiency. This minimum number is debated but has been estimated to be 25 extraperitoneal cases of rectal cancer [32], or 12 taTME cases per year [33]. This guide-line supports the pursuit of additional training necessary to support surgeons and trainees in gaining competence in performing taTME for select patients with rectal cancer.

Implications for patients

Patients may benefit from reviewing the patient-specific version of this guideline to prepare for discussions related to their rectal cancer by gaining an understanding of the potential surgical options available to them (Supplementary File 1). Patients may use the information contained in these guideline documents to engage with their surgeons in informed discussions about their care. Patients may further benefit from using the decision aids available on MAGICapp when discussing the comparative risks of laTME, roTME, and taTME to help convey the frequency at which relevant risks occur: https://app.magicapp.org/#/guideline/9532. Specifically, for any given comparison of interventions, the decision aids display the numbers needed to treat in diagrammatic format for a given outcome.

Implications for researchers

Researchers may focus on conducting high-quality randomized trials and multicenter matched cohort studies comparing outcomes between patients undergoing taTME and roTME for the treatment of low- and mid-rectal cancers, as defined below:

Comparative evidence on the quality of life in patients with low- and mid-rectal cancers undergoing taTME versus laTME—multicenter matched cohort studies.

Comparative evidence on functional outcomes such as low anterior resection syndrome and sexual function in

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 Fig. 2 taTME vs. laTME Evidence Summary

patients with low- and mid-rectal cancers undergoing taTME versus laTME—multicentre matched cohort studies.

Comparative evidence on the rate of long-term onco-logical outcomes such as 5-year overall survival and 5-year disease-free survival in patients with low- and mid-rectal cancers undergoing taTME versus laTME—randomized controlled trials or matched cohort studies.

Comparative evidence on the rate of major complications ≥ 3b according to Clavien-Dindo in patients with low- and mid-rectal cancers undergoing taTME versus laTME—matched cohort studies.

Comparative evidence on the risks, benefits, and cost-effectiveness in patients with low- and mid-rectal cancers undergoing taTME versus roTME—cost-effectiveness studies.

Establishment of a core outcome set for randomized trials evaluating surgical approaches for the treatment of rectal cancer—reviews, core stakeholder Delphi surveys, focus groups.

Implications for policy makers

Policy makers may turn toward building the infrastructure needed to facilitate patients access to taTME or roTME when clinically indicated, as outlined in this guideline. This may represent centralization of surgical management of rec-tal cancer. It may also represent justified financial billing codes in respective countries or regions. Additionally, this may involve the development of training opportunities for capacity building such as the creation of visiting fellowships or simulation training in taTME or roTME for the surgical treatment of rectal cancer.

Barriers and facilitators

Barriers may exist to the implementation of this clinical practice guideline. These include the failure to reach relevant stakeholder groups with the recommendations produced in this rapid update, as well as potential culture-related issues

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 such as the innate resistance to change practice. Furthermore, surgeons not currently performing taTME or roTME, or surgeons without access to a robot may not be able to implement recommendations from this guideline.

To improve the uptake of the recommendations from this update, we will ensure wide dissemination of this clinical practice guideline including at peer-reviewed national and international meetings. We will further disseminate through social media channels. To address the potential resistance to change innate to institutional culture, we will empower and support panelists to present the findings of this update at their local institution as well as at local and regional meetings. This will improve the dissemination of the findings of this guideline update, as our panelists will span various countries across Europe. We will meet with panelists as needed and develop tailored presentations.

Finally, we will work within the EAES to develop opportunities for training in taTME and/or roTME pending the results of the guideline update. We will do this through

the form of “Masterclass” sessions which are held at the annual meeting. The topics vary, and we will hold these as needed depending on the level of need and interest, informed through internal society surveys of our members.

Monitoring

Following dissemination of this guideline update, we will gauge the uptake of its recommendations through an internal survey of EAES members 2 years after publication of this report.

Validity period and updates

Given the anticipated results from the COLOR III trial, this guideline is subject to an update. Moreover, 11 trials were identified in clinicaltrials.gov which are actively recruiting patients for randomized trials involving “transanal total mesorectal excision” for the treatment of “rectal cancer.”

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Following the anticipated update after the release of the COLOR III trial and given the anticipated completion dates listed for the trials identified in clinicaltrials.gov, we will then aim to provide an additional update in 2029.

Limitations

This guideline has limitations. The panel discussed that while 30-day major complications capture anastomotic leaks within one month, those beyond a month were not captured in the evidence synthesis. However, the clinical impact of anastomotic leaks varies from minimal symptoms to substantial morbidity and mortality, resulting in significant heterogeneity in the reporting of anastomotic leaks [34]. Rather, anecdotally our panel felt that a more accurate outcome may be the rate of stomas at 6 or 12 months. Additionally, our data on recurrence at 2 years include both locoregional and systemic recurrence, which would otherwise lend alternate prognoses and subsequently, varying utility values. However, this is not captured here and thus the data informing this outcome must be interpreted accordingly. Additionally, multiple robotic platforms have been used across studies evaluating the efficacy and safety of roTME [35]. Similarly, multiple platforms have been implemented for taTME [36], and we were not able to examine the impact of these technological advances.

Conclusion

An international multidisciplinary panel of key stakeholders comprised of members from the EAES, ESCP, and ESGAR developed evidence-informed recommendations for the role of taTME in the surgical management of low- and mid-rectal cancers in Europe.

Supplementary Information The online version contains supplementary material available at https://doi.org/10.1007/s00464-025-12427-4.

Funding This project was funded by the European Association for Endoscopic Surgery and the European Society of Coloproctology. The funding bodies had no influence on the development of this rapid guideline or its protocol. There is no grant number linked to this research.

Declarations

Disclosures Bright Huo, Alberto Arezzo, Dana Sochorova, Amy Boyle, Yegor Tryliskyy, Iro Ntaga, Dimitris Mavridis, Michel Adamina, Patricia Sylla, Rosa Jiménez-Rodriguez, Dimitris Ntourakis, Dorin Popa, Audrius Dulskas, Suzanne Doré, Raphaela Reeb-Ilgenfritz, Sofia Gourtsoyianni, Vincenzo Vilacciar, Ivan Florez Gomez, and Stavros A. Antoniou declare no direct conflicts of interest related to this work. Indirect conflicts of external advisors were documented and managed as per Guidelines International Network Standards. Detailed conflict

of interest statements of all contributors can be found in the online appendix [17].

Ethical approval Not applicable.

Patient consent statement Not applicable.

Disclaimer This clinical practice guideline has been developed under the auspice of the European Association for Endoscopic Surgery (EAES). It is intended to be used primarily by health professionals (e.g., surgeons, anesthetists, physicians) and to assist in making informed clinical decisions on diagnostic measures and therapeutic management. It is also intended to inform individual practice of allied health professionals (e.g., surgical nurses, dieticians, physical rehabilitation therapists, psychologists); to inform strategic planning and resource management by healthcare authorities (e.g., regional and national authorities, healthcare institutions, hospital administration authorities); and to inform patients wishing to obtain an overview of the condition of interest and its management. The use of recommendations contained herein must be informed by supporting evidence accompanying each recommendation and by research evidence that might not have been published by the time of writing the present document. Users must thus base their actions informed by newly published evidence at any given point in time. The information in the guideline should not be relied upon as being complete or accurate, nor should it be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. With the rapid development of scientific knowledge, new evidence may emerge between the time the guideline is developed and when it is published or read. The guideline is not continually updated and may not reflect the most recent evidence. The guideline addresses only the topics specifically identified therein and is not applicable to other interventions, diseases, or stages of diseases.

This guideline does not mandate any particular course of medical care. Further, the guideline is not intended to substitute the independent professional judgment of the treating provider, as the guideline does not necessarily account for individual variation among patients. Even if evidence on a topic suggests a specific diagnostic and/or treatment action, users and especially health professionals may need to decide against the suggested or recommended action in view of circumstances related to patient values, preferences, co-morbidities and disease characteristics; available human, financial and material resources; and healthcare infrastructures. EAES provides this guideline on an "as is" basis, and makes no warranty, express or implied, regarding the guideline.

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Authors and Affiliations

Bright Huo$^{1,2}$ $\cdot$ Alberto Arezzo$^{3}$ $\cdot$ Dana Sochorova$^{4}$ $\cdot$ Amy Boyle$^{5}$ $\cdot$ Yegor Tryliskyy$^{6}$ $\cdot$ Iro Ntaga$^{7}$ $\cdot$ Dimitris Mavridis$^{7}$ $\cdot$ Michel Adamina$^{8}$ $\cdot$ Patricia Sylla$^{9}$ $\cdot$ Rosa Jiménez-Rodriguez$^{10}$ $\cdot$ Dimitris Ntourakis$^{11}$ $\cdot$ Dorin Popa$^{12}$ $\cdot$ Audrius Dulskas$^{13}$ $\cdot$ Sofia Gourtsoyianni$^{14}$ $\cdot$ Vincenzo Villanacci$^{15}$ $\cdot$ Ivan Florez Gomez$^{16,17,18}$ $\cdot$ Stavros A. Antoniou$^{2,19}$

☑ Stavros A. Antoniou stavros.antoniou@hotmail.com; guidelines@eae.es $^{1}$ Division of General Surgery, Department of Surgery, McMaster University, Hamilton, Canada $^{2}$ Guidelines Committee, European Association for Endoscopic Surgery, Eindhoven, Netherlands $^{3}$ Department of Surgical Sciences, University of Torino, Turin, Italy $^{4}$ Department of Surgery, Tomas Bata Hospital Zlin, Zlin, Czech Republic $^{5}$ Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada $^{6}$ Southmead Hospital, Bristol, UK $^{7}$ Department of Primary Education, School of Education, University of Ioannina, Ioannina, Greece $^{8}$ Department of Surgery, Cantonal Hospital of Fribourg and Faculty of Science and Medicine, University of Fribourg, Fribourg, Switzerland $^{9}$ Division of Colon and Rectal Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA $^{10}$ Department of General Surgery, Colorectal Unit, Hospital Universitario Virgen del Rocio, Seville, Spain

11 Division of Surgery, School of Medicine, European University Cyprus, Nicosia, Cyprus 12 Department of Surgery, Linköping University Hospital, Linköping, Sweden 13 Department of Surgery, National Cancer Institute (Lithuania), Vilnius, Lithuania 14 Department of Radiology, School of Medicine, National and Kapodistrian University of Athens, Areteion Hospital, Athens, Greece 15 Institute of Pathology, ASST Spedali Civili and University of Brescia, Brescia, Italy 16 Department of Pediatrics, University of Antioquia, Medellin, Colombia 17 Pediatric Intensive Care Unit, Clínica Las Américas-AUNA, Medellin, Colombia 18 School of Rehabilitation Science, McMaster University, Hamilton, ON, Canada 19 Department of General Surgery, Papageorgiou General Hospital, Thessaloniki, Greece