A Comparison of Three Simulators for Colposcopy LEEP Training

October 10, 2018 updated by: Ida Suzani Ismail, National University, Singapore
This randomized controlled trial evaluates the learning effectiveness of three different types of Colposcopy simulators objectively with Objective Structured Assessment of Technical Skill (OSATS) and subjectively with self-reported confidence survey. A total of 60 participants, randomly assigned into 3 groups, will learn from Hefler's, Reeve's or authors' simulators. The investigators hypothesize that the proposed simulator affords better learning objectively and subjectively with improved functional fidelity.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Colposcopy and colposcopic treatment is a unique skill that is acquired only following careful training. A colposcopist plays an important role to correctly diagnose, take appropriate biopsies and perform appropriate safe and effective treatment of women with preinvasive cervical disease. However, no surgical treatment comes without risk and colposcopy treatment is no different. Risks from a colposcopy treatment can include intraoperative complication such as bleeding, injury to surrounding organs by the instrument used i.e. laser burns, diathermy burns and damage to bladder, rectum, vulva or vagina. Other complication may include insufficient tissue excised or ablated during treatment leading to failure of cure and risk of recurrent treatment. Recurrent treatment especially excisional treatment has been shown to increase the risk of preterm labour for future pregnancies. In view of this, training in colposcopy and colposcopy treatment is a crucial part of effective cervical cancer prevention.

In this study, the investigators aim to determine if Hefler's, Reeve's or authors' simulators are more effective at supporting the colposcopy training. The significance of the result lies in the effectiveness of training simulator for colposcopy training and the confidence of doctors when they perform their first colposcopy.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • 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

  • Singapore
      • Singapore, Singapore
        • Recruiting
        • Department of Obstetrics & Gyanecology
        • Contact:

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

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Year 4 and Year 5 Medical students who have completed their Obstetrics and gynaecology attachment
  • Practicing medical doctors who have and have not performed Colposcopy LEEP

Exclusion Criteria:

  • Students who have not completed their Obstetrics and gynaecology attachment

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
Intervention / Treatment
Active Comparator: Reeve's model
After introduction of Loop excision electrosurgical procedure through video, participants will undergo Reeve's simulators
Device: Reeve's model
Reeves, K. O., Young, A. E., & Kaufman, R. H. (1999). A simple, inexpensive device for teaching the loop electrosurgical excision procedure. Obstetrics and Gynecology, 94(3), 474-5.
Active Comparator: Hefler's model
After introduction of Loop excision electrosurgical procedure through video, participants will undergo Hefler's simulators
Device: Hefler's model
Hefler, L., Grimm, C., Kueronya, V., Tempfer, C., Reinthaller, A., & Polterauer, S. (2012). A novel training model for the loop electrosurgical excision procedure: An innovative replica helped workshop participants improve their LEEP. American Journal of Obstetrics and Gynecology, 206(6)
Experimental: Ida's Model
After introduction of Loop excision electrosurgical procedure through video, participants will undergo Ida's simulators
Device: Ida's model
Reusable, portable and modular 3D printed simulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSATS Score
Time Frame: 10 minutes

Objective structured assessment of technical skills (OSATS) scores rose before and after completion of training

Competency Scale. Score of 2 indicates participant can performed task independently.Score of 1 indicates participant need help performing task. Score of 0 indicates participant has not performed the task.

  1. Use of speculum
  2. Using Colposcope for good visualization of area to be excised.
  3. Infiltration of local anaesthetic: adrenaline circumferentially around lesion to be
  4. excised using the dental syringe provided.
  5. Perform LEEP in 1 single pass producing 1 specimen only.
10 minutes
Self-reported confidence score
Time Frame: 1 minute
Likert scale of 1 to 5. Score of 1 indicates very low confidence whereas a score of 5 indicates high confidence at performing the procedures.
1 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of specimen
Time Frame: 10 minutes
Blinded assessor using validated scoring system. Score of 1 indicates very poor techniques whereas a score of 5 indicates clearly superior techniques.
10 minutes

Collaborators and Investigators

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

Sponsor

National University, Singapore

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)

September 29, 2018

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

September 30, 2018

First Submitted That Met QC Criteria

October 7, 2018

First Posted (Actual)

October 10, 2018

Study Record Updates

Last Update Posted (Actual)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S-18-072E

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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