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

August 20, 2020 updated by: Magdy Milad, MD, Northwestern University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 4 hours
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation of fine motor skills task experience with laparoscopic surgical task performance
Time Frame: 4 hours
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Student-reported confidence on laparoscopic surgical task performance
Time Frame: 4 hours
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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