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临床试验/NCT02757690
NCT02757690已完成4 期

Validation and Verification of 3 Dimensional Laparoscopic System in Laparoscopic Distal Pancreatectomy & Splenectomy

Asan Medical Center0 个研究点目标入组 60 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
60
主要终点
Operation time

研究概览

简要总结

Traditionally, laparoscopy has been based on 2-dimensional (2D) imaging, which has represented a considerable challenge for those approaching this technique. Thus, 3-dimensional (3D) visualization technology for laparoscopy has been proposed, since the early 1990s, as a way to facilitate laparoscopic performance. However, early 3D laparoscopic technology was limited in terms of image quality, so that its use had not been implemented. More recently, industry has developed novel 3D systems where the imaging is similar to stereoscopic vision, in which the depth perception is achieved by different unique images received by each eye. Thus, more recent studies have suggested a possible advantage provided by these new 3D systems during laparoscopic performance. However, comparative assessments of new generation 3D vs 2D laparoscopy remain limited, especially in the hepatobiliary and pancreatic field.

To assess the benefits and harms of use of three dimensional systems versus two dimensional systems during laparoscopic distal pancreatectomy.

详细描述

Procedures

  1. the investigators will take the patient consent for this clinical trial.
  2. The participants will be divided with two groups with block randomized method
  3. Skillful pancreatic surgeon will perform 2D or 3D laparoscopic distal pancreatectomy.
  4. The participants will be monitor the intraoperative and postoperative course.

Data collection

  1. operation video : operation time, number of errors (missed grasp, loss of material)

  2. Segmental operation time according to procedure

  3. Numbers of errors during operation

  4. clinical parameters:

研究设计

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

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI > 30 (Kg/m2)
  • History of severe or recurrent pancreatitis
  • Mass size > 10cm
  • History of low abdomen major operation
  • Additional resection for extra-pancreatic organ

排除标准

  • Participants refusal.
  • Additional resection dependent on pathological examination in intraoperative or postoperative period.

研究组 & 干预措施

2-dimenasional distal pancreatectomy

Active Comparator

device: 2 dimensional laparoscopy of Olympus

干预措施: 2-dimensional distal pancreatectomy (Device)

3-dimenasional distal pancreatectomy

Experimental

device : 3 dimensional laparoscopy of Olympus

干预措施: 3-dimensional distal pancreatectomy (Device)

结局指标

主要结局

Operation time

时间窗: expected duration: 200mins (for each operation)

The unedited videos of the operations will be assessed from start to end of the operation by two clinicians. The average of operation time will be compare according to 2D versus 3D laparoscopic system.

次要结局

  • Subjective scoring in the view of operator, 1st assist(During operation (expected duration: 200mins))
  • Numbers of errors during operation(During operation (expected duration: 200mins))

研究者

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

Song Cheol Kim

professor

Asan Medical Center

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