A Comparison of Three Simulators for Colposcopy LEEP Training
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Self-reported confidence score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Students who have not completed their Obstetrics and gynaecology attachment
研究组 & 干预措施
Reeve's model
After introduction of Loop excision electrosurgical procedure through video, participants will undergo Reeve's simulators
干预措施: Reeve's model (Device)
Hefler's model
After introduction of Loop excision electrosurgical procedure through video, participants will undergo Hefler's simulators
干预措施: Hefler's model (Device)
Ida's Model
After introduction of Loop excision electrosurgical procedure through video, participants will undergo Ida's simulators
干预措施: Ida's model (Device)
结局指标
主要结局
Self-reported confidence score
时间窗: 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
时间窗: 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.
次要结局
- Quality of specimen(10 minutes)
研究者
Ida Suzani Ismail
Instructor
National University of Singapore
