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临床试验/NCT02858986
NCT02858986已完成不适用

A Randomised Controlled Trial to Determine Whether a 3D Laparoscopic System Improves Surgeons' Performance During Laparoscopic Cholecystectomy When Compared to an Ultra-high Definition ('4K') Laparoscopic System

Royal Surrey County Hospital NHS Foundation Trust0 个研究点目标入组 120 人开始时间: 2016年9月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
主要终点
Time for completion of the key steps in laparoscopic cholecystectomy

研究概览

简要总结

Introduction: Three-dimensional key-hole surgery ('laparoscopic') systems are proven to reduce the time required to complete tasks in laboratory settings. This benefit derives from the addition of binocular depth perception cues when compared to two-dimensional (2D) systems. This year a '4K' laparoscopic system has become commercially available, so-named as it provides a high resolution 2D image with four times the number of pixels of 2D full high definition. The improved visualisation is likely to provide additional non-binocular depth cues. It is currently unclear to what degree improving the resolution of 2D systems can compensate for binocular depth cues.

Aim: To determine whether the binocular vision provided by 3D laparoscopic systems provides benefits during laparoscopic cholecystectomy when compared to the monocular vision provided by high-resolution 4K systems.

Methods: A randomised controlled trial of 3D HD versus 4K laparoscopic systems will be performed, comparing the time to complete laparoscopic cholecystectomy, and error scores.

Impact: This study is a unique, first-of-its-kind investigation into two new surgical technologies, and is the first study to involve a 4K system. The uptake of three-dimensional systems has been curbed by financial cost and the limitations of early 3D technologies. This study aims to determine which system may be the safest, quickest and most cost- effective, in order to guide future investment and technological development towards either 3D or 2D systems. In addition, these systems may also aid in the learning curve of trainee surgeons.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Informed, written consent obtained after provision of information leaflets and face-to-face answering of any questions participants may have
  • Elective laparoscopic cholecystectomy
  • Medically fit for discharge as day case
  • Age 18 to 85 years

排除标准

  • Unable to obtain informed, written consent
  • Emergency cholecystectomy
  • Not medically fit for discharge as day case
  • Age <18 or >85 years
  • Conversion to open cholecystectomy
  • History of upper abdominal surgery
  • Recent/current involvement in another clinical trial
  • Common bile duct exploration at time of operation

研究组 & 干预措施

3D laparoscopy

Experimental

Patients will undergo laparoscopic cholecystectomy using a 3D laparoscopic system

干预措施: 3D laparoscopy (Procedure)

4K laparoscopy

Experimental

Patients will undergo laparoscopic cholecystectomy using a 4K laparoscopic system

干预措施: 4K laparoscopy (Procedure)

结局指标

主要结局

Time for completion of the key steps in laparoscopic cholecystectomy

时间窗: Day of surgery

次要结局

  • Errors detected on video analysis of laparoscopic cholecystectomy as defined by a validated checklist(Day of surgery)

研究者

发起方
Royal Surrey County Hospital NHS Foundation Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matt Dunstan

Surgical Research Registrar

Royal Surrey County Hospital NHS Foundation Trust

相似试验

3D Versus 4K Laparoscopic Cholecystectomy | 临床试验