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3D-HD Optic Systems Influence Surgical Performance

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04185116
Enrollment
102
Registered
2019-12-04
Start date
2020-02-12
Completion date
2022-09-30
Last updated
2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Operative Time, Surgery--Complications

Keywords

3D optic systems, Fatigue, Length of surgery, 3D laparoscopy, Intraoperative complications, Bariatric and metabolic surgery

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.

Interventions

DEVICE3D Optic System (Olympus VISERA Elite II 3D)

Use of the 3D Optic System Olympus VISERA Elite II 3D

Sponsors

Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of SurgeryDay 1Total time to perform the jejuno-jejunal anastomosis and closure of the mesenteric defect.

Secondary

MeasureTime frameDescription
Postoperative complications90 days after surgeryClassification of the postoperative complications using the Clavien-Dindo Classification
Intraoperative complicationsDay 1Record of the intraoperative complications that may occur during the procedure (bleeding, bowel injury, mesenteric injury, disruption of the anastomotic suture)
Profile of Mood States (POMS)Day 1Measurement of self-perceived fatigue using the POMS scale
Quick Questionnaire Piper Fatigue Scale (QPFS)Day 1Measurement of self-perceived fatigue using QPFS
Visual Analogue Scale (VAS) - related fatigueDay 1Fatigue measured using the VAS

Countries

Spain

Contacts

Primary ContactVictor Turrado-Rodriguez, MD
turrado@clinic.cat+34690248236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026