ColposcopyNCT03701347
A Comparison of Three Simulators for Colposcopy LEEP Training
A study testing Reeve's model, Hefler's model and Ida's model in people with Colposcopy, run by National University of Singapore at 1 site in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colposcopy
- What is being tested?
- Reeve's model, Hefler's model and Ida's model
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 29 Sep 2018to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Students who have not completed their Obstetrics and gynaecology attachment
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Department of Obstetrics & Gyanecology
Singapore
Ida Suzani binti Ismail, 67722277, obgisi@nus.edu.sg
About this study
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.
Read the 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.
- Conditions
- Colposcopy
- Being tested
- Reeve's model, Hefler's model, Ida's model
- Keywords
- Colposcopy, Simulator, Comparison Study, Learning effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reeve's modelDevice
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.
Hefler's modelDevice
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)
Ida's modelDevice
Reusable, portable and modular 3D printed simulator
| Study group | Role | What they receive |
|---|---|---|
| Reeve's model | Active comparator | After introduction of Loop excision electrosurgical procedure through video, participants will undergo Reeve's simulators Receives: Device: Reeve's model |
| Hefler's model | Active comparator | After introduction of Loop excision electrosurgical procedure through video, participants will undergo Hefler's simulators Receives: Device: Hefler's model |
| Ida's Model | Experimental | After introduction of Loop excision electrosurgical procedure through video, participants will undergo Ida's simulators Receives: Device: Ida's model |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSATS Score
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.
- Use of speculum
- Using Colposcope for good visualization of area to be excised.
- Infiltration of local anaesthetic: adrenaline circumferentially around lesion to be
- excised using the dental syringe provided.
- Perform LEEP in 1 single pass producing 1 specimen only.
Measured: 10 minutes
Self-reported confidence score
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.
Measured: 1 minute
Secondary outcomes (1)
Quality of specimen
Blinded assessor using validated scoring system. Score of 1 indicates very poor techniques whereas a score of 5 indicates clearly superior techniques.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start29 Sep 2018
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColposcopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ida Suzani Ismail, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701347
- Sponsor's protocol ID
- S-18-072E
- Status last verified
- Sep 2018
- First submitted
- 30 Sep 2018
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Three Simulators for Colposcopy LEEP Training
- ClinicalTrials.gov ID
- NCT03701347
- Acronym / sponsor ID
- S-18-072E
- Conditions
- Colposcopy
- Keywords
- Colposcopy, Simulator, Comparison Study, Learning effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 29 Sep 2018 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 10 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reeve's model | Active comparator | Device: Reeve's modelAfter introduction of Loop excision electrosurgical procedure through video, participants will undergo Reeve's simulators |
| Hefler's model | Active comparator | Device: Hefler's modelAfter introduction of Loop excision electrosurgical procedure through video, participants will undergo Hefler's simulators |
| Ida's Model | Experimental | Device: Ida's modelAfter introduction of Loop excision electrosurgical procedure through video, participants will undergo Ida's simulators |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Students who have not completed their Obstetrics and gynaecology attachment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reeve's modelReeves, 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. | Device | Reeve's model |
| Hefler's modelHefler, 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) | Device | Hefler's model |
| Ida's modelReusable, portable and modular 3D printed simulator | Device | Ida's Model |
Primary outcome
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.
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 secondary outcome
Quality of specimen
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reeve's model, Hefler's model and Ida's model in people with Colposcopy, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSATS Score (time frame: 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.