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3D-HD Optic Systems Influence Surgical Performance

Primary Purpose

Operative Time, Fatigue, Surgery--Complications

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
3D Optic System (Olympus VISERA Elite II 3D)
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Operative Time focused on measuring 3D optic systems, Fatigue, Length of surgery, 3D laparoscopy, Intraoperative complications, Bariatric and metabolic surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Victor Turrado-RodriguezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

3D Optic Surgeons

2D Optic Surgeons

3D Optic Residents

2D Optic Residents

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Intraoperative complications
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)
Measurement of self-perceived fatigue using the POMS scale
Quick Questionnaire Piper Fatigue Scale (QPFS)
Measurement of self-perceived fatigue using QPFS
Visual Analogue Scale (VAS) - related fatigue
Fatigue measured using the VAS
Postoperative complications
Classification of the postoperative complications using the Clavien-Dindo Classification

Full Information

First Posted
September 5, 2019
Last Updated
September 11, 2021
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT04185116
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Operative Time, Fatigue, Surgery--Complications
Keywords
3D optic systems, Fatigue, Length of surgery, 3D laparoscopy, Intraoperative complications, Bariatric and metabolic surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3D Optic Surgeons
Arm Type
Experimental
Arm Description
Full-trained surgeons randomised into this interventional arm will be performing laparoscopic gastric bypass using a 3D optic system.
Arm Title
2D Optic Surgeons
Arm Type
No Intervention
Arm Description
Full-trained surgeons randomised into this interventional arm will be performing laparoscopic gastric bypass using a 2D optic system.
Arm Title
3D Optic Residents
Arm Type
Experimental
Arm Description
4th and 5th year General Surgery residentes randomised into this interventional arm will be performing laparoscopic gastric bypass using a 3D optic system.
Arm Title
2D Optic Residents
Arm Type
No Intervention
Arm Description
4th and 5th year General Surgery residentes randomised into this interventional arm will be performing laparoscopic gastric bypass using a 2D optic system.
Intervention Type
Device
Intervention Name(s)
3D Optic System (Olympus VISERA Elite II 3D)
Intervention Description
Use of the 3D Optic System "Olympus VISERA Elite II 3D"
Primary Outcome Measure Information:
Title
Duration of Surgery
Description
Total time to perform the jejuno-jejunal anastomosis and closure of the mesenteric defect.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Intraoperative complications
Description
Record of the intraoperative complications that may occur during the procedure (bleeding, bowel injury, mesenteric injury, disruption of the anastomotic suture)
Time Frame
Day 1
Title
Profile of Mood States (POMS)
Description
Measurement of self-perceived fatigue using the POMS scale
Time Frame
Day 1
Title
Quick Questionnaire Piper Fatigue Scale (QPFS)
Description
Measurement of self-perceived fatigue using QPFS
Time Frame
Day 1
Title
Visual Analogue Scale (VAS) - related fatigue
Description
Fatigue measured using the VAS
Time Frame
Day 1
Title
Postoperative complications
Description
Classification of the postoperative complications using the Clavien-Dindo Classification
Time Frame
90 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victor Turrado-Rodriguez, MD
Phone
+34690248236
Email
turrado@clinic.cat
Facility Information:
Facility Name
Victor Turrado-Rodriguez
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Turrado-Rodriguez, MD
Phone
690248236
Email
vturrador@aischannel.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25457567
Citation
Gomez-Gomez E, Carrasco-Valiente J, Valero-Rosa J, Campos-Hernandez JP, Anglada-Curado FJ, Carazo-Carazo JL, Font-Ugalde P, Requena-Tapia MJ. Impact of 3D vision on mental workload and laparoscopic performance in inexperienced subjects. Actas Urol Esp. 2015 May;39(4):229-35. doi: 10.1016/j.acuro.2014.09.008. Epub 2014 Nov 12. English, Spanish.
Results Reference
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PubMed Identifier
25002241
Citation
Alaraimi B, El Bakbak W, Sarker S, Makkiyah S, Al-Marzouq A, Goriparthi R, Bouhelal A, Quan V, Patel B. A randomized prospective study comparing acquisition of laparoscopic skills in three-dimensional (3D) vs. two-dimensional (2D) laparoscopy. World J Surg. 2014 Nov;38(11):2746-52. doi: 10.1007/s00268-014-2674-0.
Results Reference
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PubMed Identifier
22721451
Citation
Honeck P, Wendt-Nordahl G, Rassweiler J, Knoll T. Three-dimensional laparoscopic imaging improves surgical performance on standardized ex-vivo laparoscopic tasks. J Endourol. 2012 Aug;26(8):1085-8. doi: 10.1089/end.2011.0670.
Results Reference
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PubMed Identifier
25772250
Citation
Ozsoy M, Kallidonis P, Kyriazis I, Panagopoulos V, Vasilas M, Sakellaropoulos GC, Liatsikos E. Novice surgeons: do they benefit from 3D laparoscopy? Lasers Med Sci. 2015 May;30(4):1325-33. doi: 10.1007/s10103-015-1739-0. Epub 2015 Mar 15.
Results Reference
background
PubMed Identifier
25893652
Citation
Curro G, La Malfa G, Caizzone A, Rampulla V, Navarra G. Three-Dimensional (3D) Versus Two-Dimensional (2D) Laparoscopic Bariatric Surgery: a Single-Surgeon Prospective Randomized Comparative Study. Obes Surg. 2015 Nov;25(11):2120-4. doi: 10.1007/s11695-015-1674-y.
Results Reference
background
PubMed Identifier
23579515
Citation
Bilgen K, Ustun M, Karakahya M, Isik S, Sengul S, Cetinkunar S, Kucukpinar TH. Comparison of 3D imaging and 2D imaging for performance time of laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech. 2013 Apr;23(2):180-3. doi: 10.1097/SLE.0b013e3182827e17.
Results Reference
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PubMed Identifier
20480710
Citation
Andrade E, Arce C, Torrado J, Garrido J, De Francisco C, Arce I. Factor structure and invariance of the POMS Mood State Questionnaire in Spanish. Span J Psychol. 2010 May;13(1):444-52. doi: 10.1017/s1138741600003991.
Results Reference
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PubMed Identifier
23320955
Citation
Cuesta-Vargas AI, Fernandez-Lao C, Cantarero-Villanueva I, Castro-Sanchez AM, Fernandez-de-Las Penas C, Polley MJ, Arroyo-Morales M. Psychometric properties of the QuickPIPER: a shortened version of the PIPER Fatigue scale. Eur J Cancer Care (Engl). 2013 Mar;22(2):245-52. doi: 10.1111/ecc.12022. Epub 2013 Jan 16.
Results Reference
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3D-HD Optic Systems Influence Surgical Performance

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