Clinical trial NCT04524988: Comparing Proficiency of Laparoscopic Vaginal Cuff Suturing After Laparoscopic Training in Surgically Naive Students
Official title: Comparing Surgical Proficiency of Laparoscopic Vaginal Cuff Suturing in Surgically Naïve Learners After Training With Two Different Laparoscopic Simulators: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Problems
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Surgically naive premedical and medical students were trained on two different laparoscopic simulation trainers, then tested on the same vaginal cuff suturing model. Video recordings were collected from the vaginal cuff suturing tasks. These recordings were graded by expert gynecologic surgeons using a laparoscopic skills rubric. Their scores were compared to determine if one of the two laparoscopic trainers better prepared surgically naive students to complete a gynecologic surgical task.

Detailed description: Surgically naive premedical and medical students were recruited from June-November 2019. They were block randomized into two laparoscopic simulation training groups: Essentials in Minimally Invasive Gynecology (EMIG) or Fundamentals of Laparoscopic Surgery (FLS). Demographic data was collected from all participants. Participants watched instructional videos specific to their simulation trainer, as well as a video for the vaginal cuff suturing task. Participants then completed a pre-test on a vaginal cuff laparoscopic suturing model. They underwent EMIG or FLS training for approximately 2.5 hours. After training, they completed a post-test on the same vaginal cuff laparoscopic suturing model. Both pre- and post-test tasks were recorded. Video recordings were reviewed and graded by two expert high-volume MIGS surgeons who were masked to participant group (EMIG or FLS) and test phase (pre- or post-test). A modified version of the previously validated GOALS tool was used for grading. Participants also completed a survey rating their confidence level in performing laparoscopic tasks using a 5-point Likert scale after completion of their post-test vaginal cuff suturing task.

Eligibility criteria: Inclusion Criteria:

* current student enrolled in premedical internship program at Northwestern during recruitment dates
* current medical student in M1/M2 preclinical years enrolled in accredited medical school
* MD/PhD student in their PhD year(s) enrolled in accredited medical school

Exclusion Criteria:

* medical student in M3/M4 clinical years enrolled in accredited medical school

Primary outcomes:
measure: Proficiency of surgically naive premedical/medical students at completing a vaginal cuff suturing task following training on one of two laparoscopic simulators
timeFrame: 4 hours
Secondary outcomes:
measure: Correlation of fine motor skills task experience with laparoscopic surgical task performance
timeFrame: 4 hours
Other outcomes:
measure: Student-reported confidence on laparoscopic surgical task performance
timeFrame: 4 hours
Locations:
city: Chicago
country: United States
facility: 259 E Erie - Northwestern
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Magdy Milad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University Feinberg School of Medicine
name: Emily Lin, MD
role: STUDY_DIRECTOR
References: