Surgical Operating Room Enhancement Curriculum for Medical Students

NCT07006337 | Recruiting

• 1 other identifier: IRB-24-06-6938
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gynecology; Medical Education; Operating Rooms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Clinical Perceptions and Comfort with Gynecologic Emergencies

  From baseline (start of rotation) to end of rotation (5 weeks)

• Participant Satisfaction with Surgical Operating Room Curriculum

  At end of rotation (5 weeks)

Study Arms (2)

Surgical Operating Room Enrichment Course

EXPERIMENTAL

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

Standard Curriculum (Control)

ACTIVE COMPARATOR

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

Interventions

Surgical Operating Room Enrichment Course OTHER

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

Surgical Operating Room Enrichment Course

Active Comparator #1 OTHER

Active Comparator #1

Standard Curriculum (Control)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University SOM, Dept of OBGYN

Detroit, Michigan, 48201, United States

RECRUITING

Central Study Contacts

Richard Hsu, MD

CONTACT

9143628885; rihsu@med.wayne.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable. Participants, care providers, and investigators will be aware of group assignments due to the nature of the educational intervention.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Model Details: The study uses a prospective, parallel-group design. Medical students are stratified by their clinical rotation cohorts (5-week blocks) to ensure baseline equivalence in knowledge and experience. Each cohort is assigned either to the intervention or control arm for the duration of their rotation. The intervention group participates in the enrichment course, while the control group completes the standard rotation. Both groups complete knowledge and perception assessments at the end of their respective rotations

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 5, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months after publication of the main results and for up to 36 months thereafter.
• 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.

Locations

US (1)