Effects of Tissue Sealers on Minor Laparoscopic Procedures Between Obstetrics and Gynecology Residents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Vision of the surgical field
研究概览
简要总结
The kind of equipment used during laparoscopic surgery may have an effect on how quickly resident surgeons improve their skills.
The effects of these technologies on various general and specialized procedures have been the subject of numerous research, all of which have produced comparable results in terms of efficacy and safety. Although a minimally invasive laparoscopy represents the gold standard method in over 70% of procedures for uterine and adnexal benign diseases, there is a paucity of evidence regarding the potential advantages or disadvantages of such kinds of devices in gynecologic laparoscopy.
Based on this, the purpose of this study was to determine whether using a hemostatic surgical device affects how quickly gynecology residents learn to execute simple laparoscopic procedures and how well they perform surgically.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Senior gynecological surgeons
- •At least 4 years of residency in gynecology
排除标准
- •Junior residents, fellows, consultants
- •Operative procedures due to malignancy
- •Women who were not suitable for or denied a laparoscopic approach
- •Declined the procedure
- •Did not sign a written informed consent form
- •Suffering from a gynecologic malignant disease or severe systemic illnesses
- •Laparotomic conversion
结局指标
主要结局
Vision of the surgical field
时间窗: 7 days
Numeric Rate Scale (NRS) 0-10 considering 0 for "inadequate vision" and 10 for "optimal vision"
Interpretation of the difficulty of the intervention
时间窗: 7 days
NRS 0-10 (considering 0 for "extremely easy" and 10 for "extremely difficult")
次要结局
- Overall procedural satisfaction(7 days)
- Procedure time(Procedure)
研究者
Gaetano Riemma
Primary Investigator
University of Campania "Luigi Vanvitelli"