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 1 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.