Transanal total mesorectal excision versus laparoscopic total mesorectal excision for mid and low rectal cancer (COLOR III): short-term outcomes of an international, multicentre, phase 3, randomised, controlled, non-inferiority trial.

However, its oncological safety remains unclear.

然而，其肿瘤安全性仍不明确。

The COLOR III trial aimed to compare oncological outcomes between TaTME and laparoscopic TME (LapTME).

COLOR III试验旨在比较经肛门全直肠系膜切除术(TaTME)与腹腔镜全直肠系膜切除术(LapTME)的肿瘤学结果。

Here, we report the short-term secondary outcomes.

在这里，我们报告了短期次要结果。

Methods

This international, multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial was conducted at 28 hospitals globally.

这项国际多中心、开放标签、第三阶段、随机对照、非劣效试验在全球28家医院进行。

Patients (aged ≥18 years) with (y)cT1-3N0-2M0 rectal adenocarcinoma located 10 cm or less from the anal verge were randomly assigned (2:1) to TaTME or LapTME through an interactive web-response system.

年龄≥18岁的患者，患有(y)cT1-3N0-2M0直肠腺癌，肿瘤位于肛缘10厘米或以内，通过交互式网络响应系统随机分配（2:1）至TaTME或LapTME。

Randomisation was done using minimisation with stratification for sex, BMI, tumour stage, tumour height, preoperative radiotherapy, and downstaging after chemoradiotherapy.

随机分组使用最小化方法，并根据性别、体质指数（BMI）、肿瘤分期、肿瘤高度、术前放疗以及化疗放疗后的降期进行分层。

Quality assurance included pre-trial video-based competency assessment and central MRI evaluation for patient eligibility.

质量保证包括试验前基于视频的能力评估和对患者资格的中央磁共振成像（MRI）评估。

The primary endpoint, assessed for non-inferiority, is 3-year local recurrence.

主要终点，评估为非劣效性，是3年局部复发。

Short-term secondary endpoints included conversion, 90-day morbidity, anastomotic leakage, specimen quality, and circumferential resection margin (CRM) and distal resection margin (DRM) involvement.

短期次要终点包括转化、90天发病率、吻合口漏、标本质量以及环周切缘(CRM)和远端切缘(DRM)受累情况。

All analyses were conducted according to the modified intention-to-treatprinciple (analysed based on initial allocation but excluded from the analysis after randomisation if they did not undergo surgery or if they were ineligible for surgery after randomisation).

所有分析均根据修改后的意向治疗原则进行（基于初始分配进行分析，但在随机化后如果未进行手术或随机化后不适合手术则从分析中排除）。

The trial is registered at ClinicalTrials.gov (NCT02736942).

该试验已在ClinicalTrials.gov注册（NCT02736942）。

Patient recruitment has been completed and long-term follow-up for the primary endpoint is ongoing.

患者招募已经完成，主要终点的长期随访正在进行中。

Results

Between Jan 2, 2017 and Jan 16, 2024, 1205 patients were screened for eligibility, of whom 1103 were randomly assigned (735 to TaTME and 367 to LapTME).

在2017年1月2日至2024年1月16日期间，共有1205名患者进行了资格筛查，其中1103名患者被随机分配（735名接受TaTME，367名接受LapTME）。

The modified intention-to-treatpopulation consisted of 711 patients in the TaTME group and 350 in the LapTME group.

改良意向治疗人群包括711名TaTME组患者和350名LapTME组患者。

Patients were predominantly male (717 [68%] male patients vs 344 [32%] female patients), with a median age of 63·0 years (IQR 55·0-70·0) and a median BMI of 24·4 kg/m2 (22·2-26·9).

患者主要为男性（717名[68%]男性患者对比344名[32%]女性患者），中位年龄为63.0岁（四分位数间距55.0-70.0岁），中位体质指数为24.4 kg/m²（22.2-26.9 kg/m²）。

Conversion was significantly less frequent with TaTME than with LapTME (four [1%] of 696 patients vs 56 [17%] of 339; adjusted odds ratio [OR] 0·03 [95% CI 0·01-0·08]).

转换率在TaTME组显著低于LapTME组（696名患者中有4名[1%]，而339名患者中有56名[17%]；调整后的比值比[OR]为0.03[95%置信区间0.01-0.08]）。

Postoperative complications within 90 days were similar between groups (138 [20%] of 689 with TaTME vs 59 [18%] of 335 with LapTME; adjusted OR 1·22 [95% CI 0·90-1·64]).

两组90天内的术后并发症发生率相似（689名接受TaTME的患者中有138名[20%]，而335名接受LapTME的患者中有59名[18%]；调整后的比值比[OR]为1.22[95%置信区间0.90-1.64]）。

Minor morbidity (Clavien-Dindo grade ≤2) occurred in 61 (9%) of 689 participants in the TaTME group versus 26 (8%) of 333 in the LapTME group, and major morbidity (Clavien-Dindo grade ≥3) in 77 (11%) of 689 versus 31 (9%) of 333 (adjusted OR 1·23 [95% CI 0·82-1·85]).

在689名TaTME组参与者中，轻度不良事件（Clavien-Dindo分级≤2）发生在61人（9%）中，而在333名LapTME组参与者中发生在26人（8%）中；重度不良事件（Clavien-Dindo分级≥3）在689名TaTME组参与者中发生在77人（11%）中，而在333名LapTME组参与者中发生在31人（9%）中（调整后的OR为1.23 [95% 置信区间 0.82-1.85]）。

The incidenceof anastomotic leakage did not differ between treatment groups (68 [10%] of 689 patients in the TaTME group vs 27 [8%] of 333 patients in the LapTME group; adjusted OR 1·32 [95% CI 0·83-2·08]).

两组治疗之间的吻合口瘘发生率没有差异（TaTME组689名患者中有68人（10%），LapTME组333名患者中有27人（8%）；调整后的OR为1.32 [95% 置信区间 0.83-2.08]）。

Macroscopically complete resection was achieved in 583 (84%) of 692 TaTME specimens vs 291 (86%) of 339 LapTME specimens (adjusted OR 0·94 [95% CI 0·58-1·51]).

在692例TaTME标本中，有583例（84%）实现了宏观上的完全切除，而在339例LapTME标本中，有291例（86%）实现了完全切除（调整后的OR为0.94 [95% 置信区间 0.58-1.51]）。

Resection margin involvement was rare, with positive CRM in four (1%) of 611 TaTME procedures versus one (<1%) of 291 LapTME procedures, and positive DRM in seven (1%) of 690 versus one (<1%) of 334, respectively.

切除边缘受累的情况很少见，611例TaTME手术中有4例（1%）CRM阳性，而在291例LapTME手术中，有1例（<1%）CRM阳性；690例TaTME手术中有7例（1%）DRM阳性，而在334例LapTME手术中，有1例（<1%）DRM阳性。

interpretation

TaTME is a safe surgical technique for mid and low rectal cancer, achieving similar 90-day morbidity and complete resection rates to LapTME, while significantly reducing conversion rates.

TaTME 是一种安全的中低位直肠癌手术技术，其90天内的发病率和完整切除率与LapTME相似，同时显著降低了转换率。

Long-term follow-up is needed to determine functional and oncological outcomes.

需要长期随访来确定功能和肿瘤学的结果。

funding

Dutch Cancer Society, Ethicon EndoSurgery, Medtronic, Applied Medical, and Chinese Institutional funds.

荷兰癌症协会、Ethicon内窥镜手术、美敦力、应用医疗以及中国机构基金。