Medical EducationAI-T-LAPNCT07903467
Generative AI-Assisted Personalized Feedback for Laparoscopic Skill Learning in Medical Undergraduates
A study testing Generative AI-Assisted Personalized Feedback and Structured Template-Based Feedback in people with Medical Education, run by Yang Xiaodong at 1 site in China.
Trial summary
Laparoscopic skills training requires hand-eye coordination, spatial orientation, instrument control, and precise handling of materials. Structured feedback supports skills development, but frequent individualized instructor feedback may be limited by available time and resources. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medical Education
- What is being tested?
- Generative AI-Assisted Personalized Feedback and Structured Template-Based Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years and able to provide written informed consent.
- Fourth-year undergraduate medical students enrolled at Shandong University Qilu Second Hospital.
- No or limited previous laparoscopic simulation skills training, defined as no systematic completion of Fundamentals of Laparoscopic Surgery (FLS) or equivalent core laparoscopic simulation training reaching proficiency.
- Able to complete the scheduled study procedures, including baseline assessment, training sessions, post-training assessments, and follow-up assessment.
- Voluntary participation with written informed consent.
Who cannot join
- Previous systematic FLS training or equivalent laparoscopic simulation skills training with established proficiency.
- Previous laparoscopic operative experience or simulation experience likely to result in substantial ceiling effects.
- Conditions that may substantially affect fine motor skills, visuospatial ability, or safe completion of simulation tasks.
- Any other condition considered by investigators to make participation inappropriate or unsafe.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Hospital of Shandong University
Jinan, Shandong, 250033
Xiaodong Yang, Master, +86 17660084456, yangxiao@email.sdu.edu.cn
About this study
Official title: Effect of Generative Artificial Intelligence-Assisted Personalized Feedback on Laparoscopic Skill Learning in Medical Undergraduates: A Randomized Controlled Trial
Laparoscopic skills training requires hand-eye coordination, spatial orientation, instrument control, and precise handling of materials. Structured feedback supports skills development, but frequent individualized instructor feedback may be limited by available time and resources. Generative artificial intelligence (AI) may help organize performance information into personalized training recommendations.
This single-center, randomized, parallel-group, active-controlled trial plans to enroll 40 fourth-year clinical medical students with no or limited laparoscopic simulation experience. Participants will be assigned in a 1:1 ratio to AI-assisted personalized feedback or structured rule-based template feedback.
Read more
Both groups will complete the same training program using a 14-ball pegboard transfer task and study-developed shape-cutting tasks. Training duration, equipment, general instructor guidance, and four scheduled feedback opportunities will be standardized. Fundamentals of Laparoscopic Surgery (FLS) tasks will be used at scheduled assessments rather than as repeated training exercises.
The AI group will receive feedback generated through a predefined generative AI workflow using de-identified structured performance records and self-assessments. Outputs will undergo predefined quality review before delivery. The comparison group will receive feedback generated using fixed criteria, priority rules, and feedback statements.
The primary outcome is the study-defined Precision Cutting Objective Score on the FLS task after cutting training, approximately 4 weeks after baseline. The key secondary outcome is the study-defined Peg Transfer Objective Score on the FLS task after transfer training, approximately 2 weeks after baseline. Additional assessments will evaluate technical skill development and skill retention 4 to 8 weeks after training completion.
Participants will not be informed of their feedback source. Technical performance will be assessed from anonymized videos by evaluators unaware of group assignment.
The study tests the hypothesis that AI-assisted personalized feedback improves laparoscopic skills learning more than structured rule-based feedback. Because both groups receive feedback under otherwise standardized training conditions, the comparison is intended to identify the additional educational value of the AI-assisted approach.
Read the detailed description
Laparoscopic skills training requires learners to develop spatial orientation, coordinated use of both hands, stable instrument control, and accurate manipulation of materials. Formative feedback helps learners recognize technical problems and organize subsequent practice. Providing frequent individualized feedback can require substantial instructor time, while differences in how performance information is interpreted may affect the consistency of training recommendations. Generative artificial intelligence (AI) may support this process by organizing multiple sources of structured performance information into focused and actionable guidance.
This study examines the additional educational value of AI-assisted personalized feedback in a setting where both study groups receive structured feedback. The active comparator uses predefined rules and templates to provide training recommendations. The scientific question is whether generative AI can improve the integration and explanation of performance evidence, identify technical bottlenecks, and adapt practice recommendations within the study's predefined priority and target rules. The study is conducted in a laparoscopic simulation environment and evaluates learning among medical undergraduates.
The training program separates practice tasks from standardized assessment tasks. Transfer training uses a 14-ball pegboard task that requires controlled grasping, movement, placement, and coordinated instrument use. Cutting training uses study-developed shape-cutting tasks that require traction, exposure, controlled cutting, directional adjustment, and protection of the training material. Fundamentals of Laparoscopic Surgery (FLS) tasks are reserved for scheduled assessments. This separation is intended to evaluate whether skills developed through the training exercises transfer to standardized tasks that are not used for routine repeated practice.
Both groups follow the same training sequence and planned training dose. Training is generally scheduled once per week, with 60 minutes of net practice per session organized into 6-minute rounds. Equipment, materials, general task instructions, and feedback opportunities are standardized. Instructors provide common explanations, safety corrections, and assistance with equipment problems. Additional group-specific individual technical coaching outside the assigned feedback approach is not part of the planned intervention. Actual attendance, training completion, and relevant deviations are recorded.
Feedback is based on structured information confirmed by the research team. Inputs include task duration, completion status, objective error events, observer-rated technical performance, and participant self-assessments. Technical ratings are derived from independent assessments of anonymized videos, with discrepancies handled through the predefined review procedure. The feedback systems use these confirmed records and do not independently score raw videos. Missing, non-evaluable, or inconsistent information is handled according to the study's data review rules and is not replaced by invented performance data.
In the AI group, predefined prompts guide the system to integrate the available evidence, identify one or two priority technical problems, and translate these problems into specific practice recommendations. The feedback is intended to explain the relevant technical bottleneck, organize a short sequence of practice steps, and provide observable goals for the next training session. Recommendations remain subject to predefined task rules and target criteria. The system is not permitted to create unsupported numerical thresholds, infer unobserved behavior, or attribute performance to unmeasured psychological or personal characteristics.
The template group receives feedback generated by a local deterministic rule-based system. Predefined triggering conditions, priority rules, target criteria, and fixed statements determine the feedback content. Participant-specific performance values are inserted into the applicable statements. This system can identify current training priorities, recommend practice activities, and specify next-session goals. It therefore provides an active educational comparison with structured guidance. Both groups receive feedback with a similar basic organization, presentation format, and opportunity for reading before practice.
Four formative feedback events are scheduled, with two events in the transfer phase and two in the cutting phase. In each phase, the first feedback event uses the relevant phase-entry performance data and is delivered before the first training session. The second uses the same participant's previous frozen raw input together with current corresponding performance data and is delivered before the second training session. The longitudinal comparison is intended to identify improvement, persistent problems, worsening performance, or new errors and to adjust the current recommendations accordingly. Previously generated feedback text is not required as input for the second feedback event.
The AI workflow and template rules will be finalized and frozen before formal study implementation. Feedback intended for delivery undergoes a predefined release procedure. For AI outputs, review focuses on substantive issues such as incorrect use of input data, unsupported factual statements, errors in longitudinal comparison, unsafe or non-verifiable recommendations, and missing essential content. Outputs with blocking errors are regenerated or withheld according to the study procedures. Reviewers do not freely rewrite feedback solely to improve style or express a personal preference for another reasonable training recommendation. Original outputs, review decisions, and delivered versions are retained.
Participants are not proactively informed whether their feedback was produced by generative AI or the template system. Feedback uses a common visual format and delivery approach without source labels. This procedure is intended to reduce expectations associated with the feedback source, although writing style may allow some participants to form their own impressions. Technical assessors independently review videos identified by anonymized codes without access to study group or actual assessment time point. Staff responsible for generating, reviewing, and delivering feedback are not blinded and do not perform the blinded technical outcome assessments.
AI inputs contain only the de-identified structured information needed for the assigned feedback event. Raw training videos, direct personal identifiers, and patient information are not submitted to the generative AI workflow. Feedback generation is restricted to the relevant participant and the permitted current and previous training data. Future standardized assessment results and retention data are excluded from formative feedback generation. The intervention is intended to support simulation-based learning and does not establish clinical competence or authorization to perform surgery.
The randomized comparison evaluates whether the AI-assisted approach adds learning benefits beyond structured rule-based feedback under otherwise standardized training conditions. The exploratory design supports estimation of the direction and magnitude of any additional benefit, together with its uncertainty. Interpretation will remain specific to the study population, simulation tasks, and feedback procedures used in this trial.
- Conditions
- Medical Education
- Being tested
- Generative AI-Assisted Personalized Feedback, Structured Template-Based Feedback
- Keywords
- Generative artificial intelligence, Artificial intelligence-assisted feedback, Personalized feedback, Medical education, Surgical skills training, Laparoscopic skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generative AI-Assisted Personalized FeedbackBehavioural
This intervention consists of generative artificial intelligence-assisted personalized feedback provided during laparoscopic skills training. The feedback is generated through a study-specific AI workflow using de-identified structured training data, including objective task performance measures, error events, technical assessment scores, and self-assessment information. The AI-generated feedback identifies individualized training priorities, provides practice suggestions, and defines observable goals for subsequent training. All AI-generated feedback undergoes predefined quality review before delivery. Participants receive four scheduled feedback events during the training period.
Structured Template-Based FeedbackBehavioural
This intervention consists of structured template-based feedback provided during laparoscopic skills training. Feedback is generated using a predefined rule-based system with fixed criteria, priorities, target conditions, and feedback statements. The template system uses the same categories of structured training data and the same feedback schedule as the generative AI-assisted feedback group. Participants receive four scheduled feedback events during the training period.
| Study group | Role | What they receive |
|---|---|---|
| Generative AI-Assisted Personalized Feedback | Experimental | Participants assigned to this arm will receive generative artificial intelligence-assisted personalized feedback during laparoscopic skills training. Feedback will be generated using a study-specific AI workflow based on de-identified structured training data, including objective task performance measures, error events, technical assessment scores, and self-assessment information. AI-generated feedback will provide individualized training priorities, practice suggestions, and observable goals. All feedback outputs will undergo predefined quality review before delivery. Participants will receive four scheduled feedback events during the training program. Receives: Behavioral: Generative AI-Assisted Personalized Feedback |
| Structured Template-Based Feedback | Active comparator | Participants assigned to this arm will receive structured template-based feedback during laparoscopic skills training. Feedback will be generated using a predefined rule-based system with fixed criteria, priorities, target conditions, and feedback statements. The template system will use the same categories of structured training data and the same feedback schedule as the AI-assisted feedback arm. Participants will receive four scheduled feedback events during the training program. Receives: Behavioral: Structured Template-Based Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fundamentals of Laparoscopic Surgery Precision Cutting-Derived Objective Score (PCOS) at T4
Precision cutting performance will be assessed using the study-defined Precision Cutting Objective Score derived from the Fundamentals of Laparoscopic Surgery task. PCOS = max(0, 300 - T - 100 × Aerror/Atarget), where T is completion time in seconds, Aerror is the exclusive-or area between the target and actual cutting contours, and Atarget is the target area. Scores range from 0 to 300; higher scores indicate better performance. Incomplete tasks or completion times of 300 seconds or longer receive 0. Technically unevaluable assessments are treated as missing. This is a research score, not an official FLS certification score.
Measured: Immediately after completion of the cutting training phase (T4), approximately 4 weeks after baseline.
Secondary outcomes (3)
Fundamentals of Laparoscopic Surgery Peg Transfer-Derived Objective Score (PTOS) at T2
Peg transfer performance will be assessed using the study-defined Peg Transfer Objective Score derived from the Fundamentals of Laparoscopic Surgery task. PTOS = max(0, 300 - T - 100 × Nlost/6), where T is completion time in seconds and Nlost is the number of irretrievable objects. Scores range from 0 to 300; higher scores indicate better performance. Incomplete tasks or completion times of 300 seconds or longer receive 0. Recoverable drops do not incur an additional direct penalty. Technically unevaluable assessments are treated as missing. This is a research score, not an official FLS certification score.
Measured: Immediately after completion of the transfer training phase (T2), approximately 2 weeks after baseline.
Transfer Training Task Performance Assessed With the Task-Specific Behaviorally Anchored Rating Scale (TS-BARS)
Learning progression on the 14-ball transfer training task will be assessed using the study-specific Task-Specific Behaviorally Anchored Rating Scale. Seven domains are scored from 0 to 5, yielding a total score of 0-35; higher scores indicate better technical performance. The mean of two independent masked assessors' valid total scores will be used after any required discrepancy review. Repeated total scores will characterize the training trajectory.
Measured: Baseline (T0), approximately week 1 (T1), and approximately week 2 (T2).
Cutting Training Task Performance Assessed With the Task-Specific Behaviorally Anchored Rating Scale (TS-BARS)
Learning progression on the study-developed shape-cutting training task will be assessed using the study-specific Task-Specific Behaviorally Anchored Rating Scale. Seven domains are scored from 0 to 5, yielding a total score of 0-35; higher scores indicate better technical performance. The mean of two independent masked assessors' valid total scores will be used after any required discrepancy review. Repeated total scores will characterize the training trajectory.
Measured: Approximately week 2 (T2), week 3 (T3), and week 4 (T4) after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Medical EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, randomized, parallel-group, active-controlled trial. Participants will be randomly assigned in a 1:1 ratio to receive either generative artificial intelligence-assisted personalized feedback or structured template-based feedback during laparoscopic skills training. Both groups will receive identical training tasks, training duration, equipment, instructor guidance, and feedback opportunities. The intervention difference is limited to the method used to generate individualized feedback.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yang Xiaodong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yang Xiaodong, The Second Hospital of Shandong University
- Investigators
- Xiaodong Yang, Principal investigator, The Second Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903467
- Sponsor's protocol ID
- AI-LAP-RCT-V1
- Other IDs
- KYLL20260136
- Acronym
- AI-T-LAP
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the reported results may be shared with qualified researchers after publication, subject to scientific review, ethical approval, and applicable data protection requirements. Shared data may include de-identified participant-level outcome data, data dictionaries, and statistical analysis code. Identifiable information, the participant identification key, original unedited videos, and restricted AI input data will not be shared.
Publications
Godbole GH, Hawkins D, Ewool K, Camacho MHB, Karim R, Patel B. Educational Impact of Automated Feedback Systems in Surgical Training: A Systematic Review With Quantitative Synthesis. J Surg Educ. 2026 Apr;83(4):103879. doi: 10.1016/j.jsurg.2026.103879. Epub 2026 Feb 10.
PubMed 41671848Ende J. Feedback in clinical medical education. JAMA. 1983 Aug 12;250(6):777-81.
PubMed 6876333Sroka G, Feldman LS, Vassiliou MC, Kaneva PA, Fayez R, Fried GM. Fundamentals of laparoscopic surgery simulator training to proficiency improves laparoscopic performance in the operating room-a randomized controlled trial. Am J Surg. 2010 Jan;199(1):115-20. doi: 10.1016/j.amjsurg.2009.07.035.
PubMed 20103076Peters JH, Fried GM, Swanstrom LL, Soper NJ, Sillin LF, Schirmer B, Hoffman K; SAGES FLS Committee. Development and validation of a comprehensive program of education and assessment of the basic fundamentals of laparoscopic surgery. Surgery. 2004 Jan;135(1):21-7. doi: 10.1016/s0039-6060(03)00156-9. No abstract available.
PubMed 14694297
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Generative Artificial Intelligence-Assisted Personalized Feedback on Laparoscopic Skill Learning in Medical Undergraduates: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07903467
- Acronym / sponsor ID
- AI-T-LAP / AI-LAP-RCT-V1
- Conditions
- Medical Education
- Keywords
- Generative artificial intelligence, Artificial intelligence-assisted feedback, Personalized feedback, Medical education, Surgical skills training, Laparoscopic skills
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yang XiaodongUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laparoscopic skills training requires hand-eye coordination, spatial orientation, instrument control, and precise handling of materials. Structured feedback supports skills development, but frequent individualized instructor feedback may be limited by available time and resources. Generative artificial intelligence (AI) may help organize performance information into personalized training recommendations.
This single-center, randomized, parallel-group, active-controlled trial plans to enroll 40 fourth-year clinical medical students with no or limited laparoscopic simulation experience. Participants will be assigned in a 1:1 ratio to AI-assisted personalized feedback or structured rule-based template feedback.
Both groups will complete the same training program using a 14-ball pegboard transfer task and study-developed shape-cutting tasks. Training duration, equipment, general instructor guidance, and four scheduled feedback opportunities will be standardized. Fundamentals of Laparoscopic Surgery (FLS) tasks will be used at scheduled assessments rather than as repeated training exercises.
The AI group will receive feedback generated through a predefined generative AI workflow using de-identified structured performance records and self-assessments. Outputs will undergo predefined quality review before delivery. The comparison group will receive feedback generated using fixed criteria, priority rules, and feedback statements.
The primary outcome is the study-defined Precision Cutting Objective Score on the FLS task after cutting training, approximately 4 weeks after baseline. The key secondary outcome is the study-defined Peg Transfer Objective Score on the FLS task after transfer training, approximately 2 weeks after baseline. Additional assessments will evaluate technical skill development and skill retention 4 to 8 weeks after training completion.
Participants will not be informed of their feedback source. Technical performance will be assessed from anonymized videos by evaluators unaware of group assignment.
The study tests the hypothesis that AI-assisted personalized feedback improves laparoscopic skills learning more than structured rule-based feedback. Because both groups receive feedback under otherwise standardized training conditions, the comparison is intended to identify the additional educational value of the AI-assisted approach.
Detailed description
Laparoscopic skills training requires learners to develop spatial orientation, coordinated use of both hands, stable instrument control, and accurate manipulation of materials. Formative feedback helps learners recognize technical problems and organize subsequent practice. Providing frequent individualized feedback can require substantial instructor time, while differences in how performance information is interpreted may affect the consistency of training recommendations. Generative artificial intelligence (AI) may support this process by organizing multiple sources of structured performance information into focused and actionable guidance.
This study examines the additional educational value of AI-assisted personalized feedback in a setting where both study groups receive structured feedback. The active comparator uses predefined rules and templates to provide training recommendations. The scientific question is whether generative AI can improve the integration and explanation of performance evidence, identify technical bottlenecks, and adapt practice recommendations within the study's predefined priority and target rules. The study is conducted in a laparoscopic simulation environment and evaluates learning among medical undergraduates.
The training program separates practice tasks from standardized assessment tasks. Transfer training uses a 14-ball pegboard task that requires controlled grasping, movement, placement, and coordinated instrument use. Cutting training uses study-developed shape-cutting tasks that require traction, exposure, controlled cutting, directional adjustment, and protection of the training material. Fundamentals of Laparoscopic Surgery (FLS) tasks are reserved for scheduled assessments. This separation is intended to evaluate whether skills developed through the training exercises transfer to standardized tasks that are not used for routine repeated practice.
Both groups follow the same training sequence and planned training dose. Training is generally scheduled once per week, with 60 minutes of net practice per session organized into 6-minute rounds. Equipment, materials, general task instructions, and feedback opportunities are standardized. Instructors provide common explanations, safety corrections, and assistance with equipment problems. Additional group-specific individual technical coaching outside the assigned feedback approach is not part of the planned intervention. Actual attendance, training completion, and relevant deviations are recorded.
Feedback is based on structured information confirmed by the research team. Inputs include task duration, completion status, objective error events, observer-rated technical performance, and participant self-assessments. Technical ratings are derived from independent assessments of anonymized videos, with discrepancies handled through the predefined review procedure. The feedback systems use these confirmed records and do not independently score raw videos. Missing, non-evaluable, or inconsistent information is handled according to the study's data review rules and is not replaced by invented performance data.
In the AI group, predefined prompts guide the system to integrate the available evidence, identify one or two priority technical problems, and translate these problems into specific practice recommendations. The feedback is intended to explain the relevant technical bottleneck, organize a short sequence of practice steps, and provide observable goals for the next training session. Recommendations remain subject to predefined task rules and target criteria. The system is not permitted to create unsupported numerical thresholds, infer unobserved behavior, or attribute performance to unmeasured psychological or personal characteristics.
The template group receives feedback generated by a local deterministic rule-based system. Predefined triggering conditions, priority rules, target criteria, and fixed statements determine the feedback content. Participant-specific performance values are inserted into the applicable statements. This system can identify current training priorities, recommend practice activities, and specify next-session goals. It therefore provides an active educational comparison with structured guidance. Both groups receive feedback with a similar basic organization, presentation format, and opportunity for reading before practice.
Four formative feedback events are scheduled, with two events in the transfer phase and two in the cutting phase. In each phase, the first feedback event uses the relevant phase-entry performance data and is delivered before the first training session. The second uses the same participant's previous frozen raw input together with current corresponding performance data and is delivered before the second training session. The longitudinal comparison is intended to identify improvement, persistent problems, worsening performance, or new errors and to adjust the current recommendations accordingly. Previously generated feedback text is not required as input for the second feedback event.
The AI workflow and template rules will be finalized and frozen before formal study implementation. Feedback intended for delivery undergoes a predefined release procedure. For AI outputs, review focuses on substantive issues such as incorrect use of input data, unsupported factual statements, errors in longitudinal comparison, unsafe or non-verifiable recommendations, and missing essential content. Outputs with blocking errors are regenerated or withheld according to the study procedures. Reviewers do not freely rewrite feedback solely to improve style or express a personal preference for another reasonable training recommendation. Original outputs, review decisions, and delivered versions are retained.
Participants are not proactively informed whether their feedback was produced by generative AI or the template system. Feedback uses a common visual format and delivery approach without source labels. This procedure is intended to reduce expectations associated with the feedback source, although writing style may allow some participants to form their own impressions. Technical assessors independently review videos identified by anonymized codes without access to study group or actual assessment time point. Staff responsible for generating, reviewing, and delivering feedback are not blinded and do not perform the blinded technical outcome assessments.
AI inputs contain only the de-identified structured information needed for the assigned feedback event. Raw training videos, direct personal identifiers, and patient information are not submitted to the generative AI workflow. Feedback generation is restricted to the relevant participant and the permitted current and previous training data. Future standardized assessment results and retention data are excluded from formative feedback generation. The intervention is intended to support simulation-based learning and does not establish clinical competence or authorization to perform surgery.
The randomized comparison evaluates whether the AI-assisted approach adds learning benefits beyond structured rule-based feedback under otherwise standardized training conditions. The exploratory design supports estimation of the direction and magnitude of any additional benefit, together with its uncertainty. Interpretation will remain specific to the study population, simulation tasks, and feedback procedures used in this trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-center, randomized, parallel-group, active-controlled trial. Participants will be randomly assigned in a 1:1 ratio to receive either generative artificial intelligence-assisted personalized feedback or structured template-based feedback during laparoscopic skills training. Both groups will receive identical training tasks, training duration, equipment, instructor guidance, and feedback opportunities. The intervention difference is limited to the method used to generate individualized feedback.
| Arm | Type | Receives |
|---|---|---|
| Generative AI-Assisted Personalized Feedback | Experimental | Behavioral: Generative AI-Assisted Personalized FeedbackParticipants assigned to this arm will receive generative artificial intelligence-assisted personalized feedback during laparoscopic skills training. Feedback will be generated using a study-specific AI workflow based on de-identified structured training data, including objective task performance measures, error events, technical assessment scores, and self-assessment information. AI-generated feedback will provide individualized training priorities, practice suggestions, and observable goals. All feedback outputs will undergo predefined quality review before delivery. Participants will receive four scheduled feedback events during the training program. |
| Structured Template-Based Feedback | Active comparator | Behavioral: Structured Template-Based FeedbackParticipants assigned to this arm will receive structured template-based feedback during laparoscopic skills training. Feedback will be generated using a predefined rule-based system with fixed criteria, priorities, target conditions, and feedback statements. The template system will use the same categories of structured training data and the same feedback schedule as the AI-assisted feedback arm. Participants will receive four scheduled feedback events during the training program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years and able to provide written informed consent.
- Fourth-year undergraduate medical students enrolled at Shandong University Qilu Second Hospital.
- No or limited previous laparoscopic simulation skills training, defined as no systematic completion of Fundamentals of Laparoscopic Surgery (FLS) or equivalent core laparoscopic simulation training reaching proficiency.
- Able to complete the scheduled study procedures, including baseline assessment, training sessions, post-training assessments, and follow-up assessment.
- Voluntary participation with written informed consent.
Key exclusion criteria (4 listed)
- Previous systematic FLS training or equivalent laparoscopic simulation skills training with established proficiency.
- Previous laparoscopic operative experience or simulation experience likely to result in substantial ceiling effects.
- Conditions that may substantially affect fine motor skills, visuospatial ability, or safe completion of simulation tasks.
- Any other condition considered by investigators to make participation inappropriate or unsafe.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Generative AI-Assisted Personalized FeedbackThis intervention consists of generative artificial intelligence-assisted personalized feedback provided during laparoscopic skills training. The feedback is generated through a study-specific AI workflow using de-identified structured training data, including objective task performance measures, error events, technical assessment scores, and self-assessment information. The AI-generated feedback identifies individualized training priorities, provides practice suggestions, and defines observable goals for subsequent training. All AI-generated feedback undergoes predefined quality review before delivery. Participants receive four scheduled feedback events during the training period. | Behavioural | Generative AI-Assisted Personalized Feedback |
| Structured Template-Based FeedbackThis intervention consists of structured template-based feedback provided during laparoscopic skills training. Feedback is generated using a predefined rule-based system with fixed criteria, priorities, target conditions, and feedback statements. The template system uses the same categories of structured training data and the same feedback schedule as the generative AI-assisted feedback group. Participants receive four scheduled feedback events during the training period. | Behavioural | Structured Template-Based Feedback |
Primary outcome
Fundamentals of Laparoscopic Surgery Precision Cutting-Derived Objective Score (PCOS) at T4
Time frame: Immediately after completion of the cutting training phase (T4), approximately 4 weeks after baseline.
Precision cutting performance will be assessed using the study-defined Precision Cutting Objective Score derived from the Fundamentals of Laparoscopic Surgery task. PCOS = max(0, 300 - T - 100 × Aerror/Atarget), where T is completion time in seconds, Aerror is the exclusive-or area between the target and actual cutting contours, and Atarget is the target area. Scores range from 0 to 300; higher scores indicate better performance. Incomplete tasks or completion times of 300 seconds or longer receive 0. Technically unevaluable assessments are treated as missing. This is a research score, not an official FLS certification score.
3 secondary outcomes
Fundamentals of Laparoscopic Surgery Peg Transfer-Derived Objective Score (PTOS) at T2
Time frame: Immediately after completion of the transfer training phase (T2), approximately 2 weeks after baseline.
Transfer Training Task Performance Assessed With the Task-Specific Behaviorally Anchored Rating Scale (TS-BARS)
Time frame: Baseline (T0), approximately week 1 (T1), and approximately week 2 (T2).
Cutting Training Task Performance Assessed With the Task-Specific Behaviorally Anchored Rating Scale (TS-BARS)
Time frame: Approximately week 2 (T2), week 3 (T3), and week 4 (T4) after baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 41671848Godbole GH, Hawkins D, Ewool K, Camacho MHB, Karim R, Patel B. Educational Impact of Automated Feedback Systems in Surgical Training: A Systematic Review With Quantitative Synthesis. J Surg Educ. 2026 Apr;83(4):103879. doi: 10.1016/j.jsurg.2026.103879. Epub 2026 Feb 10.
- Background: PubMed 6876333Ende J. Feedback in clinical medical education. JAMA. 1983 Aug 12;250(6):777-81.
- Background: PubMed 20103076Sroka G, Feldman LS, Vassiliou MC, Kaneva PA, Fayez R, Fried GM. Fundamentals of laparoscopic surgery simulator training to proficiency improves laparoscopic performance in the operating room-a randomized controlled trial. Am J Surg. 2010 Jan;199(1):115-20. doi: 10.1016/j.amjsurg.2009.07.035.
- Background: PubMed 14694297Peters JH, Fried GM, Swanstrom LL, Soper NJ, Sillin LF, Schirmer B, Hoffman K; SAGES FLS Committee. Development and validation of a comprehensive program of education and assessment of the basic fundamentals of laparoscopic surgery. Surgery. 2004 Jan;135(1):21-7. doi: 10.1016/s0039-6060(03)00156-9. No abstract available.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the reported results may be shared with qualified researchers after publication, subject to scientific review, ethical approval, and applicable data protection requirements. Shared data may include de-identified participant-level outcome data, data dictionaries, and statistical analysis code. Identifiable information, the participant identification key, original unedited videos, and restricted AI input data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaodong Yang principal investigator
The Second Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Generative AI-Assisted Personalized Feedback and Structured Template-Based Feedback in people with Medical Education, run by Yang Xiaodong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaodong Yang, Master (+86 17660084456, yangxiao@email.sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fundamentals of Laparoscopic Surgery Precision Cutting-Derived Objective Score (PCOS) at T4 (time frame: Immediately after completion of the cutting training phase (T4), approximately 4 weeks after baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07903467, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.