A Comparison of Three Simulators for Colposcopy LEEP Training

Not Applicable

• Conditions: Colposcopy
• Interventions: Device: Hefler's model; Device: Reeve's model; Device: Ida's model

• Registration Number: NCT03701347
• Lead Sponsor: National University of Singapore

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.

Study Timeline

• Status Verified: 2018-09
• Study Start: 2018-09-29
• Study First Submitted: 2018-09-30
• Study First Submitted QC: 2018-10-07
• Study First Posted: 2018-10-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-12
• Primary Completion: 2020-09-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hefler's model	Hefler's model	After introduction of Loop excision electrosurgical procedure through video, participants will undergo Hefler's simulators
Reeve's model	Reeve's model	After introduction of Loop excision electrosurgical procedure through video, participants will undergo Reeve's simulators
Ida's Model	Ida's model	After introduction of Loop excision electrosurgical procedure through video, participants will undergo Ida's simulators

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Obstetrics & Gyanecology; 🇸🇬 Singapore, Singapore