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

Comparing Surgical Proficiency of Laparoscopic Vaginal Cuff Suturing in Surgically Naïve Learners After Training With Two Different Laparoscopic Simulators: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Educational Problems
• Intervention / Treatment: Procedure: Laparoscopic Simulation Training

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • 259 E Erie - Northwestern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fundamentals of Laparoscopic Surgery (FLS); This group will undergo 2.5h of training on the current standard laparoscopic simulation trainer (FLS), including the following tasks: peg transfer, intracorporeal knot tying and ligating loop.	Procedure: Laparoscopic Simulation Training; All participants underwent 2.5h of training with one of two laparoscopic simulation trainers (FLS or EMIG).
Experimental: Essentials in Minimally Invasive Gynecology (EMIG); This group will undergo 2.5h of training on a new gynecology-specific laparoscopic simulation trainer (EMIG), including the following tasks: peg transfer, intracorporeal knot tying and running suture.	Procedure: Laparoscopic Simulation Training; All participants underwent 2.5h of training with one of two laparoscopic simulation trainers (FLS or EMIG).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Magdy Milad, MD, Northwestern University Feinberg School of Medicine; Study Director: Emily Lin, MD, Northwestern University Feinberg School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2019
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: May 17, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 24, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: STU00209340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No