Department of Surgery B, Meir Medical Center, Sackler Faculty of Medicine, Tel-Aviv University, 4428164, Kfar Saba, Israel.
Tech Coloproctol. 2021 Jul;25(7):841-847. doi: 10.1007/s10151-021-02453-4. Epub 2021 Apr 27.
Air leak tests (ALTs) and dye leak tests (DLTs) are the most common techniques for Intraoperative colorectal anastomosis assessment. The aim of our study was to compare the sensitivity of ALT with DLT in intraoperative evaluation of colorectal anastomotic integrity and to quantify the pressures routinely used in these tests.
A prospective clinical trial was conducted on patients who had elective colorectal resection and primary anastomosis from November 2017 until July 2019 in a single academic referral center. Each patient underwent both tests. The ALT was a transanal insufflation of CO and inspection of escaping bubbles around the anastomosis immersed in saline. The DLT was a transanal infusion of diluted methylene blue and inspection of dye stains on surgical gauze wrapping the anastomosis. Peak pressures were measured. Primary endpoints were the sensitivity of ALT and DLT in detecting intraoperative leaks, quantification of intraluminal pressure routinely used in these settings and assessment of postoperative complications such as a clinical leak.
Forty patients underwent elective colorectal resection and anastomosis for malignant (67%) or benign n (33%) etiology. Height of anastomoses ranged from 1 to 25 cm (mean ± SD 12 ± 6 cm). Mean pressures measured were 26.5 ± 6.6 mmHg for the DLT and 22 ± 4 mmHg for the ALT (p < 0.01). Twenty percent of the DLTs were positive (8 patients) compared to 2.5% (1 patient) of the ALTs (RR 1.97, CI 1.2-2.7; p = 0.03). All patients who had positive tests had a suture reinforcement of the anastomosis. Only 1 patient, who had a positive DLT and ALT, developed a clinical leak CONCLUSIONS: DLT is more sensitive in detecting anastomotic leak intraoperatively. This is the first study measuring anastomotic tests' pressures used in-vivo in humans demonstrating a range of 20-30 mmHg. Based on our data we believe that a positive DLT with a negative ALT may be treated with suture reinforcement alone.
NCT03316677-10/17/2017.
空气泄漏试验（ALT）和染料泄漏试验（DLT）是评估术中结直肠吻合术的最常用技术。我们的研究目的是比较 ALT 和 DLT 在术中评估结直肠吻合完整性方面的敏感性，并量化这些测试中常规使用的压力。
一项前瞻性临床试验于 2017 年 11 月至 2019 年 7 月在一家学术转诊中心对接受择期结直肠切除术和一期吻合术的患者进行。每位患者均接受了两种测试。ALT 是通过向肛门内注入 CO 并检查浸入盐水中的吻合口周围逸出的气泡来进行的。DLT 是通过向肛门内注入稀释的亚甲蓝并检查包裹吻合口的手术纱布上的染料染色来进行的。测量峰值压力。主要终点是 ALT 和 DLT 在检测术中漏诊方面的敏感性、量化这些设置中常规使用的腔内压力以及评估术后并发症（如临床漏诊）。
40 名患者因恶性（67%）或良性（33%）病因接受了择期结直肠切除术和吻合术。吻合口高度为 1 至 25 cm（平均值±标准差 12±6 cm）。DLT 测量的平均压力为 26.5±6.6 mmHg，ALT 为 22±4 mmHg（p<0.01）。20%的 DLT 阳性（8 例），而 2.5%的 ALT 阳性（1 例）（RR 1.97，CI 1.2-2.7；p=0.03）。所有阳性试验的患者均对吻合口进行了缝线加固。只有 1 名患者，DLT 和 ALT 均为阳性，发生了临床漏诊。
DLT 在术中检测吻合口漏诊方面更敏感。这是第一项在人体中测量吻合术测试压力的研究，证明压力范围为 20-30 mmHg。根据我们的数据，我们认为 DLT 阳性而 ALT 阴性的患者可能仅需缝线加固即可。
NCT03316677-10/17/2017。
