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临床试验/NCT03701347
NCT03701347Unknown不适用

A Comparison of Three Simulators for Colposcopy LEEP Training

National University of Singapore1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年9月29日最近更新:
适应症
干预措施

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

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

Active Comparator

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

Active Comparator

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ida Suzani Ismail

Instructor

National University of Singapore

研究点 (1)

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