Clinical trial NCT04185116: 3D-HD Optic Systems Influence Surgical Performance
Official title: Improvement in Surgical Performance With 3D High Definition Systems: Olympus VISERA ELITE II 3D
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Operative Time
Fatigue
Surgery--Complications
Keywords: 3D optic systems
Fatigue
Length of surgery
3D laparoscopy
Intraoperative complications
Bariatric and metabolic surgery
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Morbid obesity (BMI \> 30)
* Laparoscopic Gastric Bypass candidates

Exclusion Criteria:

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

Primary outcomes:
measure: Duration of Surgery
timeFrame: Day 1
Secondary outcomes:
measure: Intraoperative complications
timeFrame: Day 1
measure: Profile of Mood States (POMS)
timeFrame: Day 1
measure: Quick Questionnaire Piper Fatigue Scale (QPFS)
timeFrame: Day 1
measure: Visual Analogue Scale (VAS) - related fatigue
timeFrame: Day 1
measure: Postoperative complications
timeFrame: 90 days after surgery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Victor Turrado-Rodriguez
Study officials:
References:
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