ABSTRACT
BACKGROUND: 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. METHODS: 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 CO2 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. RESULTS: 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. CLINICAL TRIAL NUMBER: NCT03316677-10/17/2017.
