General Surgery Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
BJS Open. 2023 Jul 3;7(4). doi: 10.1093/bjsopen/zrad072.
Anastomotic leakage is a major complication following rectal cancer surgery. The primary aim of this study was to investigate the efficacy of a protocol based on a quadruple intraoperative anastomotic assessment (4-Check) during transanal total mesorectal excision (TaTME).
Patients who underwent TaTME for rectal cancer with primary anastomosis were reviewed and divided into two groups: before (pre-4-Check: April 2015 - April 2019) and after the implementation of the 4-Check protocol (May 2019 - May 2022). This protocol consisted of a multimodal anastomotic integrity assessment, including indocyanine green-evaluation of colonic stump and intraluminal anastomosis perfusion, a reverse air leak test and anastomotic doughnuts assessment. The primary outcome was incidence of clinical and/or radiological anastomotic leakage. The secondary outcome included intraoperative anastomosis defects and repairs and 30-day complication rate. Propensity score matching and multivariable analyses were performed.
Of 186 patients, 160 were selected: 86 patients in the pre-4-Check and 74 in the 4-Check group. After propensity score matching, there was no difference in postoperative anastomotic leakage (pre-4-Check versus 4-Check: 11.1 per cent versus 7.4 per cent; P = 0.50). However, in the 4-Check group, the intraoperative detection of defects and repairs was significantly increased (P = 0.03), and the number of complications was reduced (pre-4-Check versus 4-Check: 33.3 per cent versus 9.3 per cent, P = 0.004). Multivariable analyses confirmed that the use of the 4-Check protocol, the detection of anastomotic defects and increased albumin levels were associated with a reduced number of complications.
The 4-Check protocol allowed the intraoperative detection and repair of anastomotic defects. Anastomotic leakage rates were not reduced; however, 30-day complication rates were lower after implementation of this protocol.
吻合口漏是直肠癌手术后的主要并发症。本研究的主要目的是研究基于经肛门全直肠系膜切除术中四重吻合评估（4-Check）的方案在经肛门全直肠系膜切除术中（TaTME）中的疗效。
回顾性分析接受 TaTME 治疗且行直肠吻合术的直肠癌患者，将患者分为两组：4-Check 方案实施前（预 4-Check：2015 年 4 月-2019 年 4 月）和实施后（2019 年 5 月-2022 年 5 月）。该方案包括多模态吻合完整性评估，包括吲哚菁绿评估结肠残端和腔内吻合口灌注、反向漏气试验和吻合环评估。主要结局是临床和/或影像学吻合口漏的发生率。次要结局包括术中吻合口缺陷和修复以及 30 天并发症发生率。进行倾向评分匹配和多变量分析。
在 186 例患者中，选择了 160 例患者：预 4-Check 组 86 例，4-Check 组 74 例。经倾向评分匹配后，两组患者术后吻合口漏发生率无差异（预 4-Check 组与 4-Check 组分别为 11.1%和 7.4%；P=0.50）。然而，在 4-Check 组，术中发现缺陷和修复的比例显著增加（P=0.03），并发症的数量减少（预 4-Check 组与 4-Check 组分别为 33.3%和 9.3%，P=0.004）。多变量分析证实，使用 4-Check 方案、吻合口缺陷的发现和白蛋白水平的升高与并发症数量的减少相关。
4-Check 方案可在术中发现和修复吻合口缺陷。吻合口漏发生率没有降低，但实施该方案后 30 天并发症发生率降低。
