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 including dehydration, high-output syndrome and metabolic complications. The Anastomotic Leak Prevention Ileostomy Tube (ALPITube) is a novel CE-marked percutaneous diversion device designed to provide anastomotic protection while avoiding traditional stoma complications.

OBJECTIVE

To evaluate the technical feasibility, safety profile and preliminary outcomes of ALPITube in an idea, development, exploration, assessment and long-term study (IDEAL) framework Stage 2a development study, with contextual comparison to 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 - Clinica La Maddalena in Palermo, Italy (n = 28), and Hospital HM Regla in León, Spain (n = 15) - between May 2023 and June 2025. Primary outcome was 30-day complication rate. Secondary outcomes included device-specific adverse events, conversion to standard ileostomy and mortality.

RESULTS

Forty-three patients were analysed (mean age 69.7 ± 9.0 years; 88.4% with ≥ 1 comorbidity; 76.7% received neoadjuvant therapy). Device implantation was technically successful in all cases (mean implantation time 38 ± 14 min). Early complications occurred in 21 patients (48.8%), and were predominantly low-grade (Clavien-Dindo I-II: 25.6%). In total, five patients (11.6%) required conversion to loop ileostomy due to device maintenance difficulties. No anastomotic leaks or high-output syndrome occurred. No adverse events were associated with device removal. Contextual comparison with literature benchmarks suggested lower rates of high-output stoma (0% versus 16%), exit-site skin complications (18.6% versus 43%), postoperative ileus (4.7% versus 33%) and parastomal hernia (0% versus 8%).

CONCLUSIONS

ALPITube demonstrates technical feasibility with an acceptable safety profile and signals potential reduction in stoma-specific complications. The 11.6% conversion rate reflects early implementation experience. These IDEAL Stage 2a findings support progression to prospective comparative studies.