Colon Anastomosis

COLOFLOW is a prospective observational study investigating whether Laser Speckle Contrast Imaging (LSCI), a dye-free and objective perfusion imaging technique, corresponds with the currently used subjective assessment of indocyanine green (ICG) fluorescence during colorectal surgery. In approximately 30 patients undergoing elective colon or rectal resection with primary anastomosis, both imaging modalities will be performed intraoperatively. The surgeons will base their clinical decisions solely on standard ICG fluorescence imaging, while LSCI measurements are collected for research purposes and do not influence treatment. Postoperatively, quantitative ICG parameters will be analysed and compared with LSCI perfusion maps to determine whether objective ICG analysis improves agreement with LSCI over subjective interpretation alone. In addition, the study will evaluate the feasibility of using the PerfusiX-IGS LSCI system during open colorectal surgery and describe postoperative outcomes, including anastomotic leakage. The ultimate goal is to contribute to more objective and standardized perfusion assessment during colorectal surgery

The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.

Postoperative complications following colon anastomosis surgery, such as adhesions, stenosis, stricture and obstruction, can significantly impact patient outcomes. The use of surgical sealants has been proposed as a means to mitigate anastomotic complications by providing a protective barrier over the anastomosis site, reducing the risk or the severity of anastomotic leak. The previous post-market clinical follow-up (PMCF) study assessed the short-term safety and performance of SEAL-G surgical sealants in preventing anastomotic leaks and early post-operative complications. However, long-term data are needed to establish its sustained safety and effectiveness. This continuation study aims to evaluate the long-term impact of the SEAL-G/MIST surgical sealant on post-operative complications over 12+ months after surgery. The study will compare complication rates in patients treated with the surgical sealant to a retrospective comparable control group who underwent similar procedures without the sealant.