Colposcopy
Conditions
Keywords
Colposcopy, Simulator, Comparison Study, Learning effectiveness
Brief 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. 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.
Interventions
DEVICEReeve'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.
DEVICEHefler'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)
DEVICEIda's model
Reusable, portable and modular 3D printed simulator
Sponsors
National University of Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OSATS Score | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of specimen | 10 minutes | Blinded assessor using validated scoring system. Score of 1 indicates very poor techniques whereas a score of 5 indicates clearly superior techniques. |
Countries
Singapore
Outcome results
None listed