Comprehensive testing of colorectal anastomosis: results of prospective observational cohort study.

BACKGROUND: Anastomotic leakage remains one of the most threatening complications in colorectal surgery. Intraoperative testing of anastomosis may reduce the postoperative anastomotic leakage rates. This study aimed to investigate a novel comprehensive intraoperative colorectal anastomosis testing technique to detect the failure of the anastomosis construction and to reduce the risk of postoperative leak. METHODS: This multi-centre prospective cohort pilot study included 60 patients who underwent colorectal resection with an anastomosis at or below 15 cm from the anal verge. Comprehensive trimodal testing consisted of indocyanine green fluorescence angiography, tension testing, air-leak, and methylene blue leak tests to evaluate the perfusion, tension, and mechanical integrity of the anastomosis. RESULTS: Ten (16.7%) patients developed an anastomotic leakage. Trimodal test was positive in 16 (26.6%) patients and the operative plan was changed for all of them. Diverting ileostomy was performed in 14 (87.5%) patients. However, two (12.5%) patients still developed clinically significant anastomotic leakage (Grade B). Forty-four (73.4%) patients had a negative trimodal test, preventive ileostomy was performed in 19 (43.2%), and five (11.4%) patients had clinically significant anastomotic leakage (Grade B and C). CONCLUSION: Trimodal testing identifies anastomoses with initial technical failure where reinforcement of anastomosis or diversion can lead to an acceptable rate of anastomotic leakage. Identification of well-performed anastomosis could allow a reduction of ileostomy rate by two-fold. However, anastomotic leakage rate remains high in technically well-performed anastomoses.

The problem of colorectal anastomosis safety.

INTRODUCTION: Anastomotic leakage (AL) remains one of the most threatening complications in colorectal surgery with the incidence of up to 20%. The aim of the study is to evaluate the safety and feasibility of novel - trimodal intraoperative colorectal anastomosis testing technique. METHODS AND ANALYSIS: This multi-center prospective cohort pilot study will include patients undergoing colorectal anastomosis formation below 15 cm from the anal verge. Trimodal anastomosis testing will include testing for blood supply by ICG fluorescence trans-abdominally and trans-anally, testing of mechanical integrity of anastomosis by air-leak and methylene blue leak tests and testing for tension. The primary outcome of the study will be AL rate at day 60. The secondary outcomes will include: the frequency of changed location of bowel resection; ileostomy rate; the rate of intraoperative AL; time, taken to perform trimodal anastomosis testing; postoperative morbidity and mortality; quality of life. DISCUSSION: Trimodal testing of colorectal anastomosis may be a novel and comprehensive way to investigate colorectal anastomosis and to reveal insufficient blood supply and integrity defects intraoperatively. Thus, prevention of these two most common causes of AL may lead to decreased rate of leakage. STUDY REGISTRATION: Clinicaltrials.gov (https://clinicaltrials.gov/): NCT03958500, May, 2019.