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.

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).