3D-HD Optic Systems Influence Surgical Performance

Not Applicable

• Conditions: Fatigue; Operative Time; Surgery--Complications
• Interventions: Device: 3D Optic System (Olympus VISERA Elite II 3D)

• Registration Number: NCT04185116
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Study Timeline

• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-04
• Study Start: 2020-02-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-11
• Last Update Posted: 2021-09-14
• Primary Completion: 2022-08
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D Optic Residents	3D Optic System (Olympus VISERA Elite II 3D)	4th and 5th year General Surgery residentes randomised into this interventional arm will be performing laparoscopic gastric bypass using a 3D optic system.
3D Optic Surgeons	3D Optic System (Olympus VISERA Elite II 3D)	Full-trained surgeons randomised into this interventional arm will be performing laparoscopic gastric bypass using a 3D optic system.

Primary Outcome Measures

Name	Time	Method
Duration of Surgery	Day 1	Total time to perform the jejuno-jejunal anastomosis and closure of the mesenteric defect.

Secondary Outcome Measures

Name	Time	Method
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)
Profile of Mood States (POMS)	Day 1	Measurement of self-perceived fatigue using the POMS scale
Quick Questionnaire Piper Fatigue Scale (QPFS)	Day 1	Measurement of self-perceived fatigue using QPFS
Visual Analogue Scale (VAS) - related fatigue	Day 1	Fatigue measured using the VAS
Postoperative complications	90 days after surgery	Classification of the postoperative complications using the Clavien-Dindo Classification

Trial Locations

Locations (1)

Victor Turrado-Rodriguez; 🇪🇸 Barcelona, Spain