Safety and Feasibility Colorectal Anastomosis Protocol Implementation: Results from the CASPI Single-Arm Pilot Study

Anastomotic leakage (AL) is a major complication of colorectal surgery. Despite multiple identified risk factors, no single strategy has proven fully effective in preventing AL. This single-arm pilot study aims to evaluate the feasibility, safety, and adherence of a multimodal colorectal anastomosis assessment protocol (CASPI) in patients undergoing surgery for colorectal cancer.

This prospective descriptive interventional single-arm pilot study included patients diagnosed with colorectal cancer who underwent surgical resection. The CASPI protocol consists of five steps: (1) indocyanine green (ICG) perfusion assessment, (2) doughnut integrity checking, (3) air leak testing, (4) intraoperative flexible endoscopy, and (5) postoperative flexible sigmoidoscopy.

A total of 34 patients were included. The median age was 63.5 years, and the median BMI was 27.7 kg/m². Twenty-seven patients had rectal tumors, and 66.7% received neoadjuvant therapy. Adherence to the protocol was 100% intraoperatively and 88.2% postoperatively. Adequate perfusion by ICG was confirmed in 94.1% of cases; intact anastomotic doughnuts were obtained in all procedures. Intraoperative endoscopy showed Grade 1 mucosa in 76.5% of patients and Grade 2 in 23.5%. No complications related to the CASPI protocol were observed. Stoma closure was performed in all patients with temporary ileostomy.

Implementation of the CASPI protocol in colorectal surgery demonstrated excellent feasibility, high adherence, and strong safety. These findings support its further evaluation in larger, controlled studies designed to assess clinical effectiveness in the incidence of anastomotic complications.