Despartment of Surgery, Coloproctology Unit, Parc Tauli University Hospital, Sabadell, Institut d'investigació i innovació Parc Tauli I3PT, Universitat Autònoma de Barcelona, Barcelona, Spain.
General and Digestive Surgery Department, Hospital Consorcio Sanitario Terrassa, Terrassa, Spain.
Br J Surg. 2023 Jan 10;110(2):150-158. doi: 10.1093/bjs/znac324.
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.
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.
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).
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.
经肛门全直肠系膜切除术（TaTME）是一种微创外科技术，试图避免转为开放手术。然而，特定的术中并发症和局部复发对该技术的适用性提出了一些质疑。本研究的主要终点是手术转换的复合结果。次要目标是评估术后恢复情况以及病理和肿瘤学结果。
这是一项前瞻性、多中心、随机、对照的开放性研究，纳入了诊断为中低位直肠腺癌的患者，这些患者接受了腹腔镜 TaTME 或腹腔镜全直肠系膜切除术（LaTME）。TaTME 技术包括腔内切除和吻合。主要结局是转为开放手术。次要结局是术后发病率、死亡率、病理、肿瘤学结果和生存情况。采用意向治疗（mITT）和方案分析。
该研究于 2015 年 4 月至 2021 年 5 月进行。患者被随机分配到 LaTME（57 例）或 TaTME（59 例）组。LaTME 组有 50 例患者和 TaTME 组有 55 例患者符合 mITT 分析。11 例患者（11%）的手术转为开放手术：LaTME 组 10 例（20%），TaTME 组 1 例（2%）（差异 18.8，95%置信区间 30 至 7；P = 0.003）。30 天时，术后恢复和发病率无显著差异；吻合口漏的发生率也无显著差异，尽管 TaTME 中发生率较低。中位随访 39 个月时，LaTME 组有 3 例局部复发（6.1%），TaTME 组有 1 例（1.8%）（95%置信区间 60 至 69；P = 0.3）。注册号：NCT02550769（http://www.clinicaltrials.gov）。
腹腔镜 TaTME 的转换率明显低于 LaTME。在经验丰富的外科医生所在的中心，腹腔镜 TaTME 可避免转为开放手术。
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