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

NCT ID: NCT04524988

Last Updated: 2020-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-05

Study Completion Date

2019-12-01

Brief Summary

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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

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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

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Educational Problems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Laparoscopic Simulation Training

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Laparoscopic Simulation Training

Intervention Type PROCEDURE

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

Interventions

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Laparoscopic Simulation Training

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Magdy Milad, MD

Albert B. Gerbie Professor; Chief, Gynecology and Gynecologic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magdy Milad, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Emily Lin, MD

Role: STUDY_DIRECTOR

Northwestern University Feinberg School of Medicine

Locations

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259 E Erie - Northwestern

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00209340

Identifier Type: -

Identifier Source: org_study_id

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