Clinical Trials Directory

Trials / Completed

CompletedNCT04524988

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
49 (actual)
Sponsor
Northwestern University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELaparoscopic Simulation TrainingAll participants underwent 2.5h of training with one of two laparoscopic simulation trainers (FLS or EMIG).

Timeline

Start date
2019-06-05
Primary completion
2019-11-15
Completion
2019-12-01
First posted
2020-08-24
Last updated
2020-08-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04524988. Inclusion in this directory is not an endorsement.