Expert Surgeons Versus Novice Residents: Validating a Novel Knot Tying Simulator for Vessel Ligation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Less extent of force while knot tying for vessel ligation
研究概览
简要总结
The investigators developed a bench-top knot tying simulator (KNOTI), with computer acquired assessment. Fifteen attending surgeons and 30 first year surgical residents were recruited to the study held at tertiary medical center during the years 2017-2018. The participants tied eight knots in different settings (Superficial vs. Deep) and techniques (One hand vs. two hands).
详细描述
The simulator is a bench-top simulator with computer acquired assessments, designed to allow novices to acquire basic surgical skills in knot tying. The simulator measures the forces used and applied on the tissue while ligating a vessel.
Each participant received instructions for approximately 10 minutes with a standardized and detailed explanation of the knot-tying technique. All knots were square knots (double-throw knot) using the same type of sutures (SOLFSILK 3.0). Participants were asked to tie two knots in four types: A superficial one hand square knot; A superficial two hand square knot; A deep one hand square knot; A deep two hand square knot.
For each knot six parameters were extracted from the sensor data: maximum upward force, maximum downward force, total upward force, total downward force, absolute non-zero force and performance time. Maximum force is the highest force applied during the knot tying.
Participants were not aware of what exact parameters the simulator was assessing. Novices were explained to avoid tissue rupture or loose knots. Knot integrity was evaluated by an investigator present during the simulation that discarded "air knots". Videos were reviewed by an investigator at post-study analysis to verify the appropriate technique and knot integrity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •residents within their first year of surgical residency
- •attending physicians from general surgery, vascular surgery, cardio-thoracic surgery and gynecology services.
排除标准
- 未提供
研究组 & 干预措施
Novice
The expert's group included 15 attending surgical faculty members in the general surgery, vascular surgery, cardio-thoracic surgery and gynecology services.
The intervention administered was the use of a simulator by the participants.
干预措施: Simulator training (Other)
Experts
For the novice group, the investigators recruited 30 residents within their first year of surgical residency (Post-Graduate Year [PGY]-1) in general surgery, vascular surgery, plastic surgery, orthopedic surgery, cardio-thoracic surgery, gynecology and urology.
The intervention administered was the use of a simulator by the participants.
干预措施: Simulator training (Other)
结局指标
主要结局
Less extent of force while knot tying for vessel ligation
时间窗: Through study completion, an average of one year.
The simulator will measure the vertical forces (in Newton) exerted while tying 8 knots for vessel ligation.
次要结局
- Identify peak force while knot tying for vessel ligation(Through study completion, an average of one year.)
研究者
Dr. Imri Amiel
Principal Investigator
Sheba Medical Center