3D-HD Optic Systems Influence Surgical Performance

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Operative Time, Fatigue, Surgery--Complications

Intervention / Treatment
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* Device: 3D Optic System (Olympus VISERA Elite II 3D)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Morbid obesity (BMI > 30) Laparoscopic Gastric Bypass candidates Exclusion Criteria: Non-obese patients. Candidates to other surgical procedures than laparoscopic gastric bypass

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D Optic Surgeons<br>Full-trained surgeons randomised into this interventional arm will be performing laparoscopic gastric bypass using a 3D optic system. | Device: 3D Optic System (Olympus VISERA Elite II 3D)<br>* Use of the 3D Optic System Olympus VISERA Elite II 3D<br>|
| No Intervention: 2D Optic Surgeons<br>Full-trained surgeons randomised into this interventional arm will be performing laparoscopic gastric bypass using a 2D optic system. | |
| Experimental: 3D Optic Residents<br>4th and 5th year General Surgery residentes randomised into this interventional arm will be performing laparoscopic gastric bypass using a 3D optic system. | Device: 3D Optic System (Olympus VISERA Elite II 3D)<br>* Use of the 3D Optic System Olympus VISERA Elite II 3D<br>|
| No Intervention: 2D Optic Residents<br>4th and 5th year General Surgery residentes randomised into this interventional arm will be performing laparoscopic gastric bypass using a 2D optic system. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Surgery | Total time to perform the jejuno-jejunal anastomosis and closure of the mesenteric defect. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative complications | Record of the intraoperative complications that may occur during the procedure (bleeding, bowel injury, mesenteric injury, disruption of the anastomotic suture) | Day 1 | 
| Profile of Mood States (POMS) | Measurement of self-perceived fatigue using the POMS scale | Day 1 | 
| Quick Questionnaire Piper Fatigue Scale (QPFS) | Measurement of self-perceived fatigue using QPFS | Day 1 | 
| Visual Analogue Scale (VAS) - related fatigue | Fatigue measured using the VAS | Day 1 | 
| Postoperative complications | Classification of the postoperative complications using the Clavien-Dindo Classification | 90 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D optic systems, Fatigue, Length of surgery, 3D laparoscopy, Intraoperative complications, Bariatric and metabolic surgery