跳至主要内容
临床试验/NCT02665000
NCT02665000Unknown不适用

A Randomised Controlled Trial Evaluating the Effects of a Structured Training Program on the Learning Curve of Residents in the Field of Laparoscopic Surgery (STAR Trial)

National University Hospital, Singapore2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年8月1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
20
试验地点
2
主要终点
The difference of the GOALS results between the 2 groups

研究概览

简要总结

1.1 Aim The investigators wish to validate a structured training program for junior residents to enhance their learning curves in performing laparoscopic appendectomy.

1.2 Hypothesis To introduce a structured laparoscopic appendectomy training program and validate its efficacy with the validated GOALS scoring system.

详细描述

  1. Background and clinical significance 2.1 Background The use of simulated training has been popularized for surgical techniques as it provides spatial and task oriented training which is vital for surgery. As more and more junior residents are performing laparoscopic appendectomy under supervision by registrars, the concern of patient safety of such early exposure without a prior structured training program is questioned. Furthermore, as these procedures are performed after office hours in our center, performance of this procedure by junior doctors may result in higher conversion rates according to a retrospective study done in our center.1 A recent leading article by Kordowicz et al stated the challenges and the importance of having validated simulator training for individual centers.2

2.2 Potential clinical significance The investigators propose that a validated training program will allow a safer training environment for junior residents. This will help to provide a standard laparoscopic training program that can be used for the training of future batches of surgical trainees coupled with improved learning curves and surgical techniques.

Studies done both locally and overseas have also shown that the presence of junior doctors in such operations can potentially increase operating time and poor surgical outcomes.3,4 Therefore, investigators also hope that with a validated training program for the residents, this can translate to improved patient outcomes and safety.

2.3 Potential benefits to the participants Direct benefit to the subjects include provision of a structured training program for participants randomized to Group A. Subjects in both groups will also receive critical assessment and feedback on their laparoscopic skills, thus contributing to the development of their surgical skills.

  1. Methods Approach 3.1 Methodology A randomized controlled trial for junior surgical residents with less than 10 laparoscopic appendectomies' experience as first surgeon will be recruited. They will be randomized to either Group A or Group B (control).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

年龄范围
24 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Junior surgical residents with less than 10 laparoscopic appendectomies' experience as first surgeon will be recruited

排除标准

  • •Residents who are in the post-graduate year 1(PGY-1) will be excluded from the study

研究组 & 干预措施

Study arm: Structured training programme

Experimental

The participants in study arm will undergo 5 days training program in laparoscopic appendectomy using the Box and Wet Trainer as intervention. Each training session will take up to 2 hours. The participant will then be exposed to the standard training in current practice over 5 supervised cases of laparoscopic appendectomy.

After the above training, they will be required to perform another 5 cases of laparoscopic appendectomy as performing surgeon under supervision by a trained surgeon. The operation will be recorded and graded based on a validated GOALS scoring system 6. The Primary Outcome will be the difference of the GOALS results between the 2 groups. Secondary outcomes will include OSAT score, patient outcome, residents' feedback score as well as conversion rates to open surgery.

干预措施: Structured training programme (Procedure)

Control arm: non-training

No Intervention

Participant in study arm will not receive any additional training during the training week. The participant will then be exposed to the standard training in current practice over 5 supervised cases of laparoscopic appendectomy.

They will be required to perform another 5 cases of laparoscopic appendectomy as performing surgeon under supervision by a trained surgeon. The operation will be recorded and then graded based on a validated GOALS scoring system 6

结局指标

主要结局

The difference of the GOALS results between the 2 groups

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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