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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Licensed physicians specializing in hepatobiliary surgery or colorectal surgery

At least 1 year of clinical experience after graduation

Willing to participate in the simulation-based decision-making study

Practicing at one of the participating tertiary academic hospitals

Disqualifiers

Not actively involved in clinical surgical decision-making

Unable to complete all required simulation sessions

Prior involvement in the development of the decision-support software

Trial population

This study will enroll physicians from three tertiary academic medical centers in China, including hepatobiliary surgeons and colorectal surgeons with varying levels of clinical experience. Participants will be required to complete standardized simulation-based case evaluations involving surgical decision-making for colorectal cancer liver metastases. The study aims to assess changes in decision-making behavior, confidence, and usability of a decision-support software system.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Unaided Clinical Decision-Making

    Other intervention

    Usual Clinical Decision-Making (Without Decision Support Software)

  • Software-Assisted Clinical Decision-Making

    Other intervention

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

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Unaided Clinical Decision-Making1 intervention
Group B: Decision-Support Software-Assisted Decision-Making1 intervention

Trial outcomes

Primary outcomes

1

Change in Surgical Decision-Making Between Software-Assisted and Non-Assisted Conditions

The primary outcome is the proportion of cases in which physicians change their surgical sequencing decision after reviewing decision-support software recommendations compared with their initial unaided decision.

Time frame
During each simulated case evaluation session

Secondary outcomes

1

Software utilization outcomes

Software adoption rate (agreement between final decision and software recommendation); Post-change adoption rate among changed decisions

Time frame
During each simulated case evaluation session
2

Decision performance outcomes

Decision-making time (seconds per case); Inter-group comparison between unaided and software-assisted conditions

Time frame
During each simulated case evaluation session
3

Human factors outcomes

Decision confidence score (5-point Likert scale)

Time frame
During each simulated case evaluation session

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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