A Comparison of Three Simulators for Colposcopy LEEP Training

Colposcopy Clinical Trial

Official title:

A Comparison of Three Simulators for Colposcopy LEEP Training

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03701347
• Other study ID #: S-18-072E
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: September 2018
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colposcopy

Intervention

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.
• 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)
• Ida's model
Reusable, portable and modular 3D printed simulator

Locations

Country	Name	City	State
Singapore	Department of Obstetrics & Gyanecology	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes
Primary	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.	1 minute
Secondary	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.	10 minutes