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

NCT04524988 | Completed

• 1 other identifier: STU00209340
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Educational Problems

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation of fine motor skills task experience with laparoscopic surgical task performance

  4 hours

Other Outcomes (1)

• Student-reported confidence on laparoscopic surgical task performance

  4 hours

Study Arms (2)

Fundamentals of Laparoscopic Surgery (FLS)

ACTIVE COMPARATOR

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

Essentials in Minimally Invasive Gynecology (EMIG)

EXPERIMENTAL

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

Interventions

Laparoscopic Simulation Training PROCEDURE

All participants underwent 2.5h of training with one of two laparoscopic simulation trainers (FLS or EMIG).

Essentials in Minimally Invasive Gynecology (EMIG); Fundamentals of Laparoscopic Surgery (FLS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

259 E Erie - Northwestern

Chicago, Illinois, 60611, United States

Location

Study Officials

• Magdy Milad, MD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

• Emily Lin, MD

  Northwestern University Feinberg School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Albert B. Gerbie Professor; Chief, Gynecology and Gynecologic Surgery

Study Record Dates

• First Submitted: May 17, 2020
• First Posted: August 24, 2020
• Study Start: June 5, 2019
• Primary Completion: November 15, 2019
• Study Completion: December 1, 2019
• Last Updated: August 24, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)