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临床试验/NCT04185116
NCT04185116Unknown不适用

Improvement in Surgical Performance With 3D High Definition Systems: Olympus VISERA ELITE II 3D

Hospital Clinic of Barcelona2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2020年2月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
102
试验地点
2
主要终点
Duration of Surgery

研究概览

简要总结

Randomized controlled trial in which two different laparoscopic systems: standard 2D and Olympus VISERA Elite II 3D will be compared in terms of laparoscopic skills, length of surgery, intraoperative complications and surgeon's fatigue in a group of senior surgeons and senior residents will be measured when performing laparoscopic Roux-en-Y gastric bypass.

详细描述

The introduction of minimally invasive surgery has faced the surgeon with some difficulties that were not present in traditional open surgery. The foremost disadvantage of laparoscopy is the loss of depth perception in 2-dimensional (2D) vision while having to operate in a 3-dimensional (3D) space.

Minimally invasive surgery has become the standard approach for most of the abdominal surgical procedures. It is associated with less surgical trauma, faster recovery, shorter hospital stay and better cosmetic results. These advantages have led laparoscopic skills to become a basic competence for general surgery programs. Advanced laparoscopic surgery involves a long learning curve, including demanding minimally invasive skills such as intracorporeal suturing and knot tying.

Video quality is critical for an accurate training. This is especially important for advanced laparoscopic skills training, where high-definition cameras are needed. HD imaging has been shown to provide subjectively improved image for visualization and to improve surgical task performance.

Some authors have investigated the effect of laparoscopic 3-dimensional view, and have demonstrated an improvement in speed, efficiency, optics and handling as well as surgeon's subjective assessment. Moreover, 3D systems have been demonstrated to provide better optical visualization that allows simpler presentation of anatomical structures, which can decrease intraoperative errors and postoperative morbidity secondary to visual distortions and may reduce postoperative fatigue of the surgeon.

The hypothesis of the study is that the length of surgery is reduced with the use of 3D laparoscopic systems compared with 2D laparoscopic systems, the reduction on the length of surgery will be higher on the training surgeons compared with the senior surgeons, and that the use of 3D laparoscopic systems reduces the postoperative fatigue of the surgeons.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • Morbid obesity (BMI > 30)
  • Laparoscopic Gastric Bypass candidates

排除标准

  • Non-obese patients.
  • Candidates to other surgical procedures than laparoscopic gastric bypass

结局指标

主要结局

Duration of Surgery

时间窗: Day 1

Total time to perform the jejuno-jejunal anastomosis and closure of the mesenteric defect.

次要结局

  • Intraoperative complications(Day 1)
  • Profile of Mood States (POMS)(Day 1)
  • Quick Questionnaire Piper Fatigue Scale (QPFS)(Day 1)
  • Visual Analogue Scale (VAS) - related fatigue(Day 1)
  • Postoperative complications(90 days after surgery)

研究者

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

Víctor Turrado-Rodríguez

Gastrointestinal Surgeon

Hospital Clinic of Barcelona

研究点 (2)

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