Surgical Operating Room Enhancement Curriculum for Medical Students

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: Recruiting
• Conditions: Medical Education; Gynecology; Operating Rooms
• Intervention / Treatment: Other: Surgical Operating Room Enrichment Course; Other: Active Comparator #1

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Richard Hsu, MD; Phone Number: 9143628885; Email: rihsu@med.wayne.edu

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Wayne State University SOM, Dept of OBGYN
      • Contact: Emma Cermak, MD; Phone Number: 914 362 8885; Email: ecermak@med.wayne.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in Knowledge and Proficiency in Gynecologic Surgical Techniques	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

Outcome Measure	Measure Description	Time Frame
Change in Clinical Perceptions and Comfort with Gynecologic Emergencies	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	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

• Sponsor: Wayne State University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 15, 2025
• First Submitted That Met QC Criteria: May 27, 2025
• First Posted (Estimated): June 5, 2025

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID 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