3D-HD Optic Systems Influence Surgical Performance

Hospital Clinic of Barcelona

Status: Unknown

Conditions: Surgery--Complications; Fatigue; Operative Time

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04185116

HCB/2018/1203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 4 patient groups

3D Optic Surgeons

Experimental group

Description:

Full-trained surgeons randomised into this interventional arm will be performing laparoscopic gastric bypass using a 3D optic system.

Treatment:

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

2D Optic Surgeons

No Intervention group

Description:

Full-trained surgeons randomised into this interventional arm will be performing laparoscopic gastric bypass using a 2D optic system.

3D Optic Residents

Experimental group

Description:

4th and 5th year General Surgery residentes randomised into this interventional arm will be performing laparoscopic gastric bypass using a 3D optic system.

Treatment:

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

2D Optic Residents

No Intervention group

Description:

4th and 5th year General Surgery residentes randomised into this interventional arm will be performing laparoscopic gastric bypass using a 2D optic system.