Transanal versus laparoscopic total mesorectal excision for mid and low rectal cancer (Ta-LaTME study): multicentre, randomized, open-label trial

Abstract

Background Transanal total mesorectal excision (TaTME) is a minimally invasive surgical technique that tries to avoid conversion to open surgery. However, specific intraoperative complications and local recurrences have cast some doubt on the suitability of the technique. The primary endpoint of the present study was a composite outcome of conversion surgery. Secondary objectives were to assess postoperative recovery, and pathological and oncological outcomes. Methods This was a prospective, multicentre, randomized, controlled open-label study of patients diagnosed with mid and low rectal adenocarcinoma who underwent laparoscopic TaTME or laparoscopic total mesorectal excision (LaTME). The TaTME technique comprised intracorporeal resection and anastomosis. Main outcomes were conversion to open surgery. Secondary outcomes were postoperative morbidity, mortality, pathological, oncological results, and survival. Modified intention-to-treat (mITT) and per-protocol analyses were performed. Results The study was conducted between April 2015 and May 2021. Patients were randomized to the LaTME (57 patients) or TaTME (59) group. Fifty patients from the LaTME group and 55 from the TaTME group were eligible for mITT analysis. The procedure was converted to open surgery in 11 patients (11 per cent): 10 (20 per cent) in the LaTME group and 1 (2 per cent) in the laparoscopic TaTME group (difference 18.8, 95 per cent c.i. 30 to 7; P = 0.003). No significant differences were found in terms of postoperative recovery and morbidity at 30 days; nor were there significant differences in anastomotic leakage, although it was less common in laparoscopic TaTME. With a median follow-up of 39 months, there were three instances of local recurrence (6.1 per cent) in the LaTME group and one (1.8 per cent) in the laparoscopic TaTME group (95 per cent c.i. 60 to 69; P = 0.3). Registration number: NCT02550769 (http://www.clinicaltrials.gov). Conclusion The conversion rate was significantly lower in laparoscopic TaTME than in LaTME. At centres with experienced surgeons, laparoscopic TaTME can avoid conversion to open surgery.

The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Rectal Cancer 2023 Supplement

“…At a median follow-up of 39 months, this trial reported LR rates of 6.1% in the l-TME group and 1.8% in the taTME group ( p = 0.3). 111 Both of the above-mentioned trials reported similar pathologic outcomes between l-TME and taTME, including status of the distal and circumferential resection margins and completeness of the mesorectal specimen. 111 None of these procedures resulted in CO 2 embolism or urethral injury.…”

Efficacy of reinforcing sutures for prevention of anastomotic leakage after low anterior resection for rectal cancer: A systematic review and meta‐analysis

“…The incidence of anastomotic leakage in transabdominal and transanal rectal cancer surgery remains controversial 28,29 . We performed subgroup analysis based on different surgical approach.…”

Discordance in TME Specimen Grading in a Prospective Phase II Multicenter Rectal Cancer Trial

“…In the first 2 RCTs published to date comparing outcomes of laparoscopic versus taTME in sphincter-saving LAR for rectal cancer, the rate of IC TME was 0% in both trials’ taTME arms, totaling 599 patients. The wide-ranging variation in reported rates of IC TME raises questions regarding QC measures used to validate the assessment of TME grade in prospective observational and randomized trials 30,31 . Liu et al 30 acknowledged that despite an independent review by an oversight committee, an over-estimation bias for successful resection, based on the TME grading assessed by pathologists at each of the 16 participating institutions, still remains a “certain possibility.” Among 13 prospective and randomized rectal cancer surgical trials published or ongoing, only 7 described pathology QC measures to validate the accuracy of TME specimen grading, (Supplemental File 5, http://links.lww.com/SLA/E739).…”

“…Large taTME series and registries report CRM-positive rates ranging from 1.4% to 12.7% 21–25 and rates of IC TME ranging from 1.5% to 11% 24,26–29 . In the first 2 RCTs comparing laparoscopic to taTME, CRM-positive rates varied from 0% to 2.4% with IC TME reported in 0% to 22% 30,31 . The variability in mesorectal grade reported in RCTs raises questions regarding the internal validity of reported TME grades and whether quality control (QC) measures should be systematically implemented in the assessment of this key pathologic endpoint 30,32 .…”

“…24,[26][27][28][29] In the first 2 RCTs comparing laparoscopic to taTME, CRMpositive rates varied from 0% to 2.4% with IC TME reported in 0% to 22%. 30,31 The variability in mesorectal grade reported in RCTs raises questions regarding the internal validity of reported TME grades and whether quality control (QC) measures should be systematically implemented in the assessment of this key pathologic endpoint. 30,32 Few RCT protocols describe centralized blinded review of TME specimens, or random audits of pathology reports and TME photographs.…”