Comparing Proficiency of Laparoscopic Vaginal Cuff Suturing After Laparoscopic Training in Surgically Naive Students

Educational Problems Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04524988
• Other study ID #: STU00209340
• Status: Completed
• Phase: N/A
• Start date: June 5, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: August 2020
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 1, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Educational Problems

Intervention

Procedure:
• Laparoscopic Simulation Training
All participants underwent 2.5h of training with one of two laparoscopic simulation trainers (FLS or EMIG).

Locations

Country	Name	City	State
United States	259 E Erie - Northwestern	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Student-reported confidence on laparoscopic surgical task performance	All participants completed a survey after training where they rated their confidence in performing individual laparoscopic tasks using a 5-point Likert scale. Scores will be compared between the two study arms to determine if either simulator is associated with higher confidence ratings for completing laparoscopic tasks.	4 hours
Primary	Proficiency of surgically naive premedical/medical students at completing a vaginal cuff suturing task following training on one of two laparoscopic simulators	Using a previously validated laparoscopic skills assessment tool (Global Operative Assessment of Laparoscopic Skills, or GOALS), two expert MIGS surgeons reviewed each video and scored it using a modified version of the GOALS tool. Each participant was ultimately given a GOALS composite score, which was made up of 8 individual skill domains (3 of which were added to make the scoring relevant and specific to the vaginal cuff suturing task). The GOALS scores serve to measure student surgical proficiency at laparoscopic tasks.	4 hours
Secondary	Correlation of fine motor skills task experience with laparoscopic surgical task performance	Demographic data was collected from each participant in a survey prior to their training session. This data included experience with fine motor skills tasks, including video games, sewing and playing an instrument. As above, objective performance scores were obtained after video grading using a modified version of the GOALS tool. GOALS scores from participants with fine motor skills task performance were compared with GOALS scores for participants without the same prior fine motor skills task experience to assess for associations between performance and previous fine motor skill task experience.	4 hours