Routine Endoscopic evaluation of colorectal anastomoses for early detection of Anastomotic Leakage (REAL study): protocol for a multicenter prospective study.

Introduction: Early detection and timely treatment of anastomotic leakage (AL) following rectal surgery are crucial for improving outcomes. However, no standardized early detection pathway exists. This study evaluates a multicenter clinical care pathway integrating bedside endoscopy to reduce time to diagnose AL.

Methods: This international, multicenter, prospective observational study evaluates early endoscopic inspection for AL detection. Endoscopic assessments are performed at the bedside using a point-of-care digital rectoscope. Eligible patients include those undergoing colorectal resection for cancer with a colorectal or coloanal anastomosis within 15 cm of the anorectal junction. The clinical pathway includes bedside endoscopic inspection 3-6 days post-surgery, C-reactive protein-guided CT scans with rectal contrast, and follow-up endoscopy at 2-3 weeks. The primary outcome is time to AL diagnosis. Secondary outcomes include diagnostic accuracy, patient-reported comfort (Modified Gloucester Scale), stoma rate, anastomosis healing at one year, and cost-effectiveness. A propensity score-matched historical cohort will be used for comparison. Based on previous reports, we hypothesize this pathway will reduce the median diagnosis time from 15 to 5 days. With 95% confidence and 80% power, 130 patients are needed, with 153 total to account for a 15% maximum dropout rate.

Conclusion: The REAL study is designed to evaluate whether a clinical pathway incorporating routine endoscopic assessment of colorectal anastomoses reduces time to diagnosis of AL and initiation of treatment.