NCT04999007

Artificial Intelligence Assists Surgeons' Decision Making

Artificial Intelligence-assisted Decision Making for Temporary Ileostomy: A Prospective Randomized Controlled Trail.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 616 (estimated)
• Sponsor: Jichao Qin · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate whether artificial intelligence technique reduces the temporary ileostomy rate in patients with rectal cancer who receive anterior resection.

Detailed description

Anastomotic leakage is a serious and life-threatening complication after anterior resection in patients with rectal cancer, and temporary ileostomy was introduced to reduce the serious consequences due to anastomotic leakage. However, whether a temporary ileostomy is applied in the surgery depends on the surgeon's experience, and there are no clinical guidelines to follow. Recently, artificial intelligence has widely been applied in medical field and produced some exciting results, and we have developed a high-performance artificial intelligence model based on 2369 rectal cancer patients, which showed good discrimination of anastomotic leakage and may reduce the temporary ileostomy rate. Hence, this randomized controlled trail will evaluate the artificial intelligence model for guiding surgical decision-making of performing a temporary ileostomy in patients with rectal cancer who receive anterior resection.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
OTHER	Artificial intelligence algorithm	Temporary ileostomy will be performed in the patients with high-risk of anastomotic leakage and not performed in the patients with low-risk of anastomotic leakage.

Timeline

• Start date: 2021-09-02
• Primary completion: 2025-09-01
• Completion: 2025-10-01
• First posted: 2021-08-10
• Last updated: 2024-11-21

Locations

1 site across 1 country: China