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Clinical Trials/NCT04185116
NCT04185116
Unknown
Not Applicable

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

Hospital Clinic of Barcelona1 site in 1 country102 target enrollmentFebruary 12, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Operative Time
Sponsor
Hospital Clinic of Barcelona
Enrollment
102
Locations
1
Primary Endpoint
Duration of Surgery
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 12, 2020
End Date
September 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Víctor Turrado-Rodríguez

Gastrointestinal Surgeon

Hospital Clinic of Barcelona

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

Outcomes

Primary Outcomes

Duration of Surgery

Time Frame: Day 1

Total time to perform the jejuno-jejunal anastomosis and closure of the mesenteric defect.

Secondary Outcomes

  • Intraoperative complications(Day 1)
  • Profile of Mood States (POMS)(Day 1)
  • Quick Questionnaire Piper Fatigue Scale (QPFS)(Day 1)
  • Visual Analogue Scale (VAS) - related fatigue(Day 1)
  • Postoperative complications(90 days after surgery)

Study Sites (1)

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