The objective of this international prospective observational study is to evaluate the implementation of a point-of-care digital rectoscope (LumenEye) into routine care to detect colorectal anastomotic leakage in the early postoperative period.
The study includes patients undergoing a colorectal resection with colorectal or coloanal anastomosis ≤15 centimeters from the anorectal junction. The participating centers consist of expert colorectal units in various countries.
The primary endpoint for the study is the time to diagnosis of anastomotic leakage.
≥ 18 years of age
The participant underwent an open or minimally invasive, sphincter preserving surgery with the construction of a colorectal or coloanal anastomosis ≤15 centimetres from the anorectal junction.
Adequate comprehension of the country specific or English language
Written informed consent
None
The study population comprises patients undergoing a colorectal resection with anastomosis.
Cohort
Prospective
Routine endoscopic anastomosis inspection
DeviceThe routine care pathway for early detection of anastomotic leakage includes: * C-reactive protein guided imaging * Rectoscopy of the anastomosis three to six days after surgery * Rectoscopy of the anastomosis two to three weeks after surgery
Time to diagnosis of anastomotic leakage
Diagnostic accuracy of point-of-care rectoscopy for detection of AL
Determination of the sensitivity, specificity, negative- and positive predictive values for detecting AL with regards to CT-scan, flexible endoscopy and clinical findings
Patient reported comfort score for diagnostic endoscopy (Gloucester Comfort Scale),
a score of 1 refers to no discomfort while 5 is associated with severe discomfort
Hospital costs of the diagnostic protocol for detection of AL
The direct hospital costs related to the diagnostics aimed at detecting AL
Readmission rate
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