A Comparison of Three Simulators for Colposcopy LEEP Training

National University of Singapore

Status: Unknown

Conditions: Colposcopy

Treatments: Device: Ida's model; Device: Reeve's model; Device: Hefler's model

Study type: Interventional

Funder types: Other

Identifiers

NCT03701347

S-18-072E

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Reeve's model

Active Comparator group

Description:

After introduction of Loop excision electrosurgical procedure through video, participants will undergo Reeve's simulators

Treatment:

Device: Reeve's model

Hefler's model

Active Comparator group

Description:

After introduction of Loop excision electrosurgical procedure through video, participants will undergo Hefler's simulators

Treatment:

Device: Hefler's model

Ida's Model

Experimental group

Description:

After introduction of Loop excision electrosurgical procedure through video, participants will undergo Ida's simulators

Treatment:

Device: Ida's model