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.
Percutaneous ALPITube ileostomy for colorectal anastomotic protection: a multicentre feasibility study
Mussa, B.
2026-01-01
Abstract
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.
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