Surgery · Medical Literature
Quality of life, bowel dysfunction, and long-term oncological outcomes after transanal versus laparoscopic total mesorectal excision for mid- and low- rectal cancer (Ta-LaTME study): multicentre randomized open-label trial.
Abstract
Quality of life (QoL) and bowel function are key outcomes in mid- and low rectal cancer. The comparative impact of laparoscopic total mesorectal excision (LaTME) versus transanal total mesorectal excision (TaTME) on patient-reported outcomes and long-term oncological results in randomized trials remains unclear. This prospective multicentre randomized trial enrolled patients with resectable mid-low rectal adenocarcinoma. QoL was assessed using the 30- and 29-item European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaires EORTC QLQ-C30 and QLQ-CR29, respectively) and bowel dysfunction was assessed using the Low Anterior Resection Syndrome (LARS) score before surgery and at the long-term follow-up (≥ 12 months after index surgery). The sample size calculation was based on the primary endpoint from the original randomized clinical trial (composite conversion outcome), for which 116 patients were required. The minimum oncological follow-up was 5 years. Modified intention-to-treat (mITT) and per-protocol analyses were prespecified. In all, 116 patients were randomized (LaTME, 57; TaTME, 59); 105 patients were included in the mITT analysis. Sixty-seven valid QoL questionnaires were obtained (63.8%). Postoperative global health status (EORTC QLQ-C30) was high in both groups (median score 83.3) with no significant differences between them, and functional scales remained near maximum, with improved emotional functioning after LaTME only. Using the EORTC QLQ-CR29 score, TaTME showed higher postoperative stool frequency, flatulence, and faecal incontinence, with similar body image and sexual function. LARS scores (assessed only in patients without a permanent stoma) were comparable between LaTME and TaTME (median 24 versus 27, respectively), with major LARS (score 30-42) in 30 and 44% of LaTME and TaTME patients respectively. There were no significant differences between LaTME and TaTME in local recurrence (6.4% versus 3.7%, respectively), distant recurrence (14.9% versus 18.5%, respectively), disease-free survival, and overall survival. Overall QoL and bowel function remained high, with no detectable between-group differences. TaTME was associated with a higher burden of specific evacuatory symptoms on the EORTC QLQ-CR29. Long-term oncological outcomes did not differ significantly between techniques. Registration number: NCT02550769 (http://www.clinicaltrials.gov).
Clinical relevance
In patients with resectable mid- and low-rectal adenocarcinoma, does transanal total mesorectal excision (TaTME) differ from laparoscopic total mesorectal excision (LaTME) in long-term quality of life, bowel dysfunction (LARS score), or 5-year oncological outcomes? __SNAPSHOT__ {"studyDesign":"Prospective multicentre randomized open-label trial (long-term follow-up analysis of the Ta-LaTME RCT); modified intention-to-treat (mITT) and per-protocol analyses prespecified","setting":"Multicentre; Spain (Parc Tauli University Hospital [Sabadell] and affiliated institutions including Hospital Consorcio Sanitario Terrassa, Hospital General de Catalunya, Hospital Universitario Mutua de Terrassa)","sampleSize":"116 patients randomized (LaTME: 57; TaTME: 59); 105 patients included in the mITT analysis","population":"Adults with resectable mid- or low-rectal adenocarcinoma eligible for sphincter-preserving TME; specific staging criteria not reported in available abstract","intervention":"Transanal total mesorectal excision (TaTME) performed via TEO (transanal endoscopic operation) platform with intracorporeal resection and anastomosis, transanal specimen extraction","comparator":"Laparoscopic total mesorectal excision (LaTME) performed in accordance with the COLOR II study protocol","primaryOutcome":"The sample size was powered on the primary endpoint of the original RCT (composite conversion outcome); QoL (EORTC QLQ-C30 and QLQ-CR29), bowel dysfunction (LARS score), and long-term oncological outcomes (minimum 5-year follow-up) are the outcomes of interest in this companion report. The designated primary endpoint for this long-term paper is not explicitly stated in the available abstract.","followUp":"Minimum oncological follow-up of 5 years; QoL and LARS assessed at ≥12 months after index surgery (long-term follow-up); baseline assessments performed preoperatively","fundingSource":"No financial support required per original publication (evaluation of habitual clinical practice); supported by Societat Catalana de Cirurgia, Institut d'investigació i innovació Parc Tauli I3PT, and an IDCSALUD–Hospital General de Catalunya research prize"}
Key findings
Only the abstract is available for this 2026 BJS Open publication; the full quantitative results (between-group differences in EORTC QLQ-C30, QLQ-CR29, and LARS scores, as well as 5-year local recurrence rates, disease-free survival, and overall survival) are not reported in the truncated abstract provided. The trial enrolled 116 patients (LaTME n=57, TaTME n=59), of whom 105 were included in the mITT analysis. QoL was assessed preoperatively and at ≥12 months postoperatively using EORTC QLQ-C30 and QLQ-CR29; bowel dysfunction was assessed using the LARS score at the same time points. The minimum oncological follow-up was 5 years. No specific absolute or relative effect sizes, confidence intervals, p-values, NNT, NNH, or adverse event rates are available from the abstract as provided. All comparative outcome data must be obtained from the full publication.
Practice implications
This study represents one of the few randomized trials with prespecified long-term (≥5-year) oncological follow-up and patient-reported outcome (PRO) data comparing TaTME and LaTME for mid- and low-rectal cancer — a clinically important gap in the literature. The trial was powered on a composite conversion outcome from the original RCT, meaning it was not independently powered to detect differences in QoL, LARS, or oncological endpoints; this limits the inferential strength of any non-significant comparisons in those domains. Given the prior publication of the original Ta-LaTME RCT (BJS 2023) and existing meta-analytic evidence suggesting similar functional and QoL outcomes between the two approaches, this companion paper appears designed to provide confirmatory long-term data rather than test a novel hypothesis. Critically, only the abstract was available for review: conclusions about which patients benefit more from TaTME versus LaTME, whether meaningful between-group differences in QoL or LARS were observed, and whether 5-year oncological equivalence was demonstrated cannot be drawn without the full results. Results may not generalize to surgeons outside high-volume expert centres, as TaTME was supervised by an experienced team to mitigate learning-curve bias. __LIMITATIONS__ Sample size (n=116, mITT n=105) was calculated for the original composite conversion endpoint, not for QoL, LARS, or oncological outcomes; the study is almost certainly underpowered to detect clinically meaningful differences in these secondary endpoints.,Open-label design precludes blinding of patients and surgeons to surgical approach, introducing potential performance and reporting bias in patient-reported outcomes.,Single primary-centre expertise for TaTME with supervised outreach to co-enrolling sites limits generalizability to non-expert settings.,The abstract is truncated; specific numerical results, dropout/loss-to-follow-up rates, and handling of missing PRO data are not assessable.,Potential selection bias: eligibility criteria and baseline tumour characteristics (stage, neoadjuvant treatment, BMI, sex distribution) are not confirmed in the available abstract, making it difficult to verify between-group comparability at long-term follow-up.,Minimum follow-up of 5 years does not guarantee median or mean follow-up, and exact numbers at risk at oncological endpoints are not reported.,Non-industry-funded status reduces sponsorship bias but does not eliminate institutional or investigator allegiance bias given the originating centre's expertise in TaTME. __BOTTOM_LINE_CATEGORY__ potentially_practice_informing __BOTTOM_LINE__ This long-term companion analysis of the Ta-LaTME RCT provides randomized comparative data on QoL, bowel dysfunction (LARS), and ≥5-year oncological outcomes for TaTME versus LaTME in mid- and low-rectal cancer — a clinically meaningful but previously absent evidence base. The trial was underpowered for these endpoints, and the full quantitative results are not available from the abstract alone; clinicians should review the complete publication before drawing practice-changing conclusions. Pending full data review, this study is most appropriately viewed as confirmatory or hypothesis-generating rather than independently practice-changing.