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NCT07760558

COLORS-Validate Study of Decision-Support Software for Surgical Sequencing in Colorectal Liver Metastases

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

Summary

This study evaluates a surgical decision-support software designed to assist physicians in selecting the optimal surgical sequence for patients with colorectal cancer liver metastases. In this multicenter prospective simulation study, participating surgeons from multiple centers will review standardized clinical case scenarios. For each case, physicians will first make a surgical sequencing decision based on their own clinical judgment. They will then review the recommendation provided by the decision-support software and make a second decision if they choose to revise their initial plan. The study will assess whether the software influences clinical decision-making, including changes in surgical strategy, decision confidence, decision time, and agreement with software recommendations. Physician user experience will also be evaluated using standardized questionnaires, including system usability and cognitive workload scales. The goal of this study is to determine the clinical utility and usability of the decision-support software in improving surgical decision-making consistency and supporting clinical reasoning in colorectal liver metastases cases.

Official title: Clinical Utility Evaluation of a Surgical Sequencing Decision-Support Software in Simulated Cases of Colorectal Liver Metastases: A Multicenter Prospective Study (COLORS-Validate Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

12

Start Date

2026-09-01

Completion Date

2026-10-30

Last Updated

2026-08-12

Healthy Volunteers

Yes

Interventions

OTHER

Unaided Clinical Decision-Making

Usual Clinical Decision-Making (Without Decision Support Software)

OTHER

Software-Assisted Clinical Decision-Making

Physicians make surgical sequencing decisions after reviewing recommendations generated by the decision-support software, including weighted scores and predicted outcomes.