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3D-HD Optic Systems Influence Surgical Performance

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状态招聘中
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Hospital Clinic of Barcelona

关键词

抽象

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.

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.

In this study a group of full-trained surgeons and of 4th and 5th year General Surgery Residents performing laparoscopic Roux-en-Y Gastric Bypass will be randomized into the use of 2D standard laparoscopic optics or 3D laparoscopic optics.

日期

最后验证: 06/30/2020
首次提交: 09/04/2019
提交的预估入学人数: 12/02/2019
首次发布: 12/03/2019
上次提交的更新: 07/27/2020
最近更新发布: 07/28/2020
实际学习开始日期: 02/11/2020
预计主要完成日期: 04/30/2021
预计完成日期: 06/30/2021

状况或疾病

Operative Time
Fatigue
Surgery--Complications

干预/治疗

Device: 3D Optic System (Olympus VISERA Elite II 3D)

-

手臂组

干预/治疗
Experimental: 3D Optic Surgeons
Full-trained surgeons randomised into this interventional arm will be performing laparoscopic gastric bypass using a 3D optic system.
No Intervention: 2D Optic Surgeons
Full-trained surgeons randomised into this interventional arm will be performing laparoscopic gastric bypass using a 2D optic system.
Experimental: 3D Optic Residents
4th and 5th year General Surgery residentes randomised into this interventional arm will be performing laparoscopic gastric bypass using a 3D optic system.
No Intervention: 2D Optic Residents
4th and 5th year General Surgery residentes randomised into this interventional arm will be performing laparoscopic gastric bypass using a 2D optic system.

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别All
接受健康志愿者
标准

Inclusion Criteria:

- Morbid obesity (BMI > 30)

- Laparoscopic Gastric Bypass candidates

Exclusion Criteria:

- Non-obese patients.

- Candidates to other surgical procedures than laparoscopic gastric bypass

结果

主要结果指标

1. Duration of Surgery [Day 1]

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

次要成果指标

1. Intraoperative complications [Day 1]

Record of the intraoperative complications that may occur during the procedure (bleeding, bowel injury, mesenteric injury, disruption of the anastomotic suture)

2. Profile of Mood States (POMS) [Day 1]

Measurement of self-perceived fatigue using the POMS scale

3. Quick Questionnaire Piper Fatigue Scale (QPFS) [Day 1]

Measurement of self-perceived fatigue using QPFS

4. Visual Analogue Scale (VAS) - related fatigue [Day 1]

Fatigue measured using the VAS

5. Postoperative complications [90 days after surgery]

Classification of the postoperative complications using the Clavien-Dindo Classification

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