Percutaneous ALPITube Ileostomy for Colorectal Anastomotic Protection: A Multicentre Feasibility Study

Background Standard loop ileostomy protects low colorectal anastomoses but causes substantial stoma-related morbidity. ALPITube is a novel percutaneous diversion device designed to provide anastomotic protection while avoiding traditional stoma complications. Objective To evaluate the feasibility, safety, and preliminary efficacy of ALPITube compared with published loop ileostomy benchmarks. Methods Multicentre retrospective cohort study of consecutive patients undergoing elective colorectal surgery with low anastomosis and ALPITube diversion at two European centres (May 2023-June 2025). Primary outcome was 30-day complication rate. Secondary outcomes included device-specific complications, conversion to standard ileostomy, and mortality. Results Forty-three patients were analyzed (mean age 69.7 ± 9.0 years; 88.4% with comorbidities; 76.7% received neoadjuvant therapy). Device implantation was technically successful in all cases (mean implantation time 38 ± 14 minutes). Early complications occurred in 21 patients (48.8%), predominantly low-grade (Clavien-Dindo I-II: 32.6%). Five patients (11.6%) required conversion to loop ileostomy. No anastomotic leaks occurred. Compared with literature benchmarks, ALPITube showed significantly lower rates of high-output stoma (0% vs 16%), peristomal skin complications (18.6% vs 43%), postoperative ileus (4.7% vs 33%), and parastomal hernia (0% vs 8%) (all p < 0.05). Conclusion ALPITube demonstrates technical feasibility with encouraging safety signals and potential reduction in stoma-specific complications. These proof-of-concept findings support progression to randomized controlled trials.