At a glance
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The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients: A Prospective, Multicenter, Open-label, Non-inferiority, Randomized Controlled Study
In Brief
A clinical study evaluating Stent-based Diverting Technique for Rectal Neoplasms. Completed, enrolled 570 participants across 20 sites.
Detailed Summary
The goal of this clinical trial is to evaluate the safety and efficiency of stent-based tiverting technique (SDT) versus ileostomy in rectal cancer patients. After the removal of the rectal tumor, participants who are at high risk for anastomotic leakage will either undergo SDT or ileostomies. Researchers will compare SDT to see if SDT could help patients save hospital stays, lower medical costs, and enhance their quality of life, and not alternatively avoid defunction stoma.
Study Details
Timeline
Interventions
The stent-based diverting technique (SDT) contains two parts to achieve feces diversion One is a degradable solid intestinal stent to be implanted 20 cm from the terminal ileum and could be gradually degraded within 3-4 weeks. Another part is a drainage tube to be placed at the proximal 5-10 cm of the aforementioned stent. Given this SDT, intestinal contents could be diverted through the drainage tube, and the stent prevents the feces from entering the distal intestinal. After removing the drainage tube after 3-4 weeks, intestinal contents will freely access the distal intestinal space following the degradation of the stent. For patients, stoma reversal is avoided.