Tokyo, Oct. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059439) titled 'A Multicenter Prospective Study Using Video Review to Evaluate the Effectiveness of an AI-Based Surgical Navigation System in Preventing Intraoperative Organ Injury' on Oct. 17.
Study Type:
Observational
Primary Sponsor:
Institute - Kawaguchi Municipal Medical Center
Condition:
Condition - Colorectal cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to scientifically evaluate the effectiveness of the AI-based surgical navigation system "Eureka" in supporting intraoperative recognition of organ injury and preventing postoperative complications. This will be achieved by analyzing laparoscopic surgical videos in which organ injury previously occurred, and conducting a multi-reviewer assessment by experienced surgeons.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - Injury Cases (Video Materials):
1 Laparoscopic colorectal surgeries performed at either Kawaguchi Municipal Medical Center or Machida Municipal Hospital during the study period in which intraoperative organ injury was confirmed.
2 Patients aged 20 years or older.
3 Written informed consent obtained for research and educational use of surgical videos.
4 Videos deemed appropriate for study use following review by multiple board-certified expert colorectal surgeons.
Video Reviewers:
Practicing gastrointestinal surgeons who voluntarily agreed to participate without compensation.
Key exclusion criteria - Surgeons who performed or were involved in the original surgeries corresponding to the videos were excluded.
Target Size - 150
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 04 Month 01 Day
Date of IRB - 2025 Year 05 Month 01 Day
Anticipated trial start date - 2025 Year 06 Month 01 Day
Last follow-up date - 2026 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066511
Disclaimer: Curated by HT Syndication.