Abstract
BACKGROUND: Anastomotic leakage remains a serious concern in rectal cancer patients undergoing neoadjuvant chemoradiotherapy (nCRT) followed by low anterior resection (LAR). To mitigate this risk, protective ileostomy (PI) is often employed; however, it carries its own complications and patient burden. This study aimed to evaluate the feasibility and clinical outcomes of ghost ileostomy (GI) as a potential alternative, aiming to reduce unnecessary stoma creation, related morbidity, readmission rates, and patient discomfort. METHODS: In this randomized, non-inferiority feasibility trial, patients with rectal cancer who had received nCRT and were scheduled for LAR were enrolled. Feasibility outcomes included recruitment rate, retention, intervention adherence, procedural fidelity, and safety. Safety outcomes compared GI and PI regarding anastomotic leakage and failure, bowel obstruction, acute tubular necrosis (ATN), and readmissions due to complications (primary endpoint). RESULTS: Eighty patients were randomized from 87 eligible participants, with a recruitment rate of 5.71 patients per site-month. GI was non-inferior to PI regarding overall complications and readmissions (one-tailed 90% CI; power > 80%) and also for obstruction and ATN (one-tailed 95% CI; power > 80%). However, the PI group had a significantly shorter initial hospital stay than the GI group (p = 0.042). CONCLUSION: This trial supports the feasibility of a definitive future study. GI may serve as a safe and effective alternative to PI in selected low-risk rectal cancer patients undergoing nCRT and LAR. Larger, multicenter trials are needed to validate these findings and further explore the clinical utility of GI.