Abstract
OBJECTIVE: This study aimed to synthesize the best available evidence and integrate clinical expertise to develop a structured, evidence-based leakage management system for cancer-preventive ileostomy care. METHODS: A two-phase mixed-methods design was employed. First, a systematic review was conducted following the PIPOST framework (Population: cancer-preventive ileostomy patients; Intervention: leakage management strategies; Professionals: ostomy caregivers; Outcomes: leakage incidence and skin complications; Setting: hospitals; Evidence types: clinical decisions, guidelines, evidence summaries, best practices, systematic reviews, and expert consensus). Databases and clinical repositories were searched from inception to June 2024, yielding 23 high-quality documents. Second, a Delphi consensus process involving 15 ostomy nursing experts across six Chinese provinces refined the evidence into actionable clinical protocols through two iterative consultation rounds. Consensus thresholds included a Likert score ≥ 4 and coefficient of variation < 0.25. RESULTS: The finalized leakage management system comprises three domains-prevention, assessment, and intervention-organized into 11 themes and 46 actionable items. Key components include preventive strategies for ileostomy leakage, dynamic ostomy appliance selection, and protocols for managing leakage-related skin damage. Expert consensus highlighted the importance of individualized care, with adjustments based on effluent characteristics and gas production. The Delphi panel achieved high agreement (Cr = 0.89, Kendall's W = 0.194-0.137, P < 0.05). CONCLUSIONS: This study presents a robust, evidence-based leakage management system tailored to the needs of cancer-preventive ileostomy survivors. By integrating high-quality evidence with practical clinical insights, the system offers valuable guidance for improving patient outcomes and enhancing the quality of ostomy nursing care in real-world settings. SYSTEMATIC REVIEW REGISTRATION: ES20245104.