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.