Surgical Operating Room Enhancement Curriculum for Medical Students

May 27, 2025 updated by: Richard Hsu, Wayne State University

Surgical Operating Room Enhancement Curriculum for Medical Students: A Quality Improvement and Prospective Cohort Study

The goal of this clinical trial is to assess whether integrating an enhanced Surgical Operating Room (OR) curriculum into the medical student program improves knowledge and proficiency in gynecologic surgical techniques and procedures among medical students at Wayne State University. The main questions it aims to answer are:

Does the Surgical Operating Room Enrichment Course increase medical students' knowledge and comfort with gynecologic surgical procedures?

Does participation in the course improve students' clinical perceptions and management of gynecologic emergencies?

Researchers will compare students who participate in the Surgical Operating Room Enrichment Course (intervention group) to those who complete the standard rotation (control group) to see if the enhanced curriculum leads to greater improvements in knowledge and clinical skills.

Participants will:

Attend virtual didactic lectures covering gynecologic anatomy, perioperative care, surgical techniques, and management of gynecologic emergencies

Complete pre- and post-training surveys assessing knowledge, skills, and perceptions related to gynecologic surgery

This study involves approximately 60 medical students, with participation being voluntary and all responses de-identified.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University SOM, Dept of OBGYN
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Medical students currently enrolled in the Wayne State University OBGYN clinical rotation (5-week block)
  • Willingness to voluntarily participate in surveys and training sessions
  • Ability to attend all didactic lectures

Exclusion Criteria:

  • Prior completion of a structured surgical operating room enrichment course (e.g., elective subspecialty training)
  • Inability to participate virtual sessions due to conflicting clinical/academic schedules
  • Non-English speakers (due to English-language survey instruments)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Surgical Operating Room Enrichment Course
Participants in this arm will receive the enhanced Surgical Operating Room (OR) Enrichment Course as part of their medical student curriculum. This intervention includes both didactic lectures led by gynecology-trained physicians. The curriculum covers preoperative evaluation, perioperative complication prevention, gynecologic anatomy, surgical techniques, gynecologic emergencies, operative decision-making, postoperative care, and OR tasks and procedures. Participants will complete pre- and post-intervention surveys to assess changes in knowledge, proficiency, and clinical perceptions related to gynecologic surger
Other: Surgical Operating Room Enrichment Course
The intervention consists of multiple structured training sessions delivered during the gynecology rotation. Sessions include lectures on surgical principles and gynecologic procedures. The course is taught by OBGYN physicians and is designed to enhance students' proficiency in surgical techniques, perioperative care, and management of gynecologic emergencies. Educational materials are based on relevant surgical guidelines and textbooks
Active Comparator: Standard Curriculum (Control)
Participants in this arm will follow the standard medical student curriculum for the gynecology rotation, without the additional enrichment course. At the end of their rotation, they will complete a questionnaire assessing their baseline knowledge and perceptions of gynecologic surgery. No additional didactic or hands-on surgical skills training beyond the standard curriculum will be provided to this group
Other: Active Comparator #1
Active Comparator #1

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Knowledge and Proficiency in Gynecologic Surgical Techniques
Time Frame: From baseline (start of rotation) to end of rotation (5 weeks)
Assessed by the difference in scores on a validated knowledge and skills questionnaire administered before and after participation in the Surgical Operating Room Enrichment Course. The questionnaire evaluates understanding of gynecologic anatomy, surgical steps, perioperative care, and technical proficiency, using a combination of multiple-choice, Likert scale, and open-ended questions. Improvement will be measured by comparing pre- and post-intervention scores within and between the intervention and control groups.
From baseline (start of rotation) to end of rotation (5 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Clinical Perceptions and Comfort with Gynecologic Emergencies
Time Frame: From baseline (start of rotation) to end of rotation (5 weeks)
Measured by the difference in self-reported confidence and comfort levels in managing gynecologic emergencies, as captured by Likert scale items and open-ended responses in the pre- and post-intervention surveys. This outcome will assess whether the enrichment course influences students' perceived preparedness for real-world clinical scenarios.
From baseline (start of rotation) to end of rotation (5 weeks)
Participant Satisfaction with Surgical Operating Room Curriculum
Time Frame: At end of rotation (5 weeks)
Assessed via post-intervention survey items evaluating satisfaction with the curriculum content, teaching methods, and perceived educational value. Survey includes Likert scale and open-ended feedback questions.
At end of rotation (5 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wayne State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-24-06-6938

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual participant data,including data dictionaries, survey responses, and outcome measures, will be shared with qualified researchers for independent scientific research, following publication of the main results. No personal identifiers or protected health information (PHI) will be included.

IPD Sharing Time Frame

Data will be available beginning 6 months after publication of the main results and for up to 36 months thereafter.

IPD Sharing Access Criteria

Access to IPD and supporting documents will be granted to qualified researchers with an approved research proposal and statistical analysis plan. Requestors must sign a data sharing agreement too. Requests can be submitted to the principal investigator via institutional contact.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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