Operative TimeNCT04185116
3D-HD Optic Systems Influence Surgical Performance
A study testing 3D Optic System (Olympus VISERA Elite II 3D) in people with Operative Time and Fatigue, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Operative Time, Fatigue, Surgery--Complications
- What is being tested?
- 3D Optic System (Olympus VISERA Elite II 3D)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSpain
- Study dates
- 12 Feb 2020to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Morbid obesity (BMI > 30)
- Laparoscopic Gastric Bypass candidates
Who cannot join
- Non-obese patients.
- Candidates to other surgical procedures than laparoscopic gastric bypass
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Victor Turrado-Rodriguez
Barcelona, 08036
Victor Turrado-Rodriguez, MD, 690248236, vturrador@aischannel.com
About this study
Official title: Improvement in Surgical Performance With 3D High Definition Systems: Olympus VISERA ELITE II 3D
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.
Read the 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.
- Conditions
- Operative Time, Fatigue, Surgery--Complications
- Being tested
- 3D Optic System (Olympus VISERA Elite II 3D)
- Keywords
- 3D optic systems, Fatigue, Length of surgery, 3D laparoscopy, Intraoperative complications, Bariatric and metabolic surgery
- Medical subject headings
- Fatigue, Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Optic System (Olympus VISERA Elite II 3D)Device
Use of the 3D Optic System "Olympus VISERA Elite II 3D"
| Study group | Role | What they receive |
|---|---|---|
| 3D Optic Surgeons | Experimental | Full-trained surgeons randomised into this interventional arm will be performing laparoscopic gastric bypass using a 3D optic system. Receives: Device: 3D Optic System (Olympus VISERA Elite II 3D) |
| 2D Optic Surgeons | No intervention | Full-trained surgeons randomised into this interventional arm will be performing laparoscopic gastric bypass using a 2D optic system. |
| 3D Optic Residents | Experimental | 4th and 5th year General Surgery residentes randomised into this interventional arm will be performing laparoscopic gastric bypass using a 3D optic system. Receives: Device: 3D Optic System (Olympus VISERA Elite II 3D) |
| 2D Optic Residents | No intervention | 4th and 5th year General Surgery residentes randomised into this interventional arm will be performing laparoscopic gastric bypass using a 2D optic system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Surgery
Total time to perform the jejuno-jejunal anastomosis and closure of the mesenteric defect.
Measured: Day 1
Secondary outcomes (5)
Intraoperative complications
Record of the intraoperative complications that may occur during the procedure (bleeding, bowel injury, mesenteric injury, disruption of the anastomotic suture)
Measured: Day 1
Profile of Mood States (POMS)
Measurement of self-perceived fatigue using the POMS scale
Measured: Day 1
Quick Questionnaire Piper Fatigue Scale (QPFS)
Measurement of self-perceived fatigue using QPFS
Measured: Day 1
Visual Analogue Scale (VAS) - related fatigue
Fatigue measured using the VAS
Measured: Day 1
Postoperative complications
Classification of the postoperative complications using the Clavien-Dindo Classification
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start12 Feb 2020
- Primary completionAug 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Operative TimeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Víctor Turrado-Rodríguez, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185116
- Sponsor's protocol ID
- HCB/2018/1203
- Status last verified
- Sep 2021
- First submitted
- 5 Sep 2019
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25457567Alaraimi 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.
PubMed 25002241Honeck 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.
PubMed 22721451Ozsoy 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.
PubMed 25772250Curro 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.
PubMed 25893652Bilgen 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.
PubMed 23579515Andrade 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.
PubMed 20480710Cuesta-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.
PubMed 23320955
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in Surgical Performance With 3D High Definition Systems: Olympus VISERA ELITE II 3D
- ClinicalTrials.gov ID
- NCT04185116
- Acronym / sponsor ID
- HCB/2018/1203
- Conditions
- Operative Time, Fatigue, Surgery--Complications
- Keywords
- 3D optic systems, Fatigue, Length of surgery, 3D laparoscopy, Intraoperative complications, Bariatric and metabolic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 3D Optic Surgeons | Experimental | Device: 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. |
| 2D Optic Surgeons | No intervention | –Full-trained surgeons randomised into this interventional arm will be performing laparoscopic gastric bypass using a 2D optic system. |
| 3D Optic Residents | Experimental | Device: 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. |
| 2D Optic Residents | No intervention | –4th and 5th year General Surgery residentes randomised into this interventional arm will be performing laparoscopic gastric bypass using a 2D optic system. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Morbid obesity (BMI > 30)
- Laparoscopic Gastric Bypass candidates
Key exclusion criteria (2 listed)
- Non-obese patients.
- Candidates to other surgical procedures than laparoscopic gastric bypass
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Optic System (Olympus VISERA Elite II 3D)Use of the 3D Optic System "Olympus VISERA Elite II 3D" | Device | 3D Optic Residents, 3D Optic Surgeons |
Primary outcome
Duration of Surgery
Time frame: Day 1
Total time to perform the jejuno-jejunal anastomosis and closure of the mesenteric defect.
5 secondary outcomes
Intraoperative complications
Time frame: Day 1
Profile of Mood States (POMS)
Time frame: Day 1
Quick Questionnaire Piper Fatigue Scale (QPFS)
Time frame: Day 1
Visual Analogue Scale (VAS) - related fatigue
Time frame: Day 1
Postoperative complications
Time frame: 90 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Background: PubMed 25457567Gomez-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.
- Background: PubMed 25002241Alaraimi 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.
- Background: PubMed 22721451Honeck 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.
- Background: PubMed 25772250Ozsoy 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.
- Background: PubMed 25893652Curro 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.
- Background: PubMed 23579515Bilgen 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.
- Background: PubMed 20480710Andrade 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.
- Background: PubMed 23320955Cuesta-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Optic System (Olympus VISERA Elite II 3D) in people with Operative Time and Fatigue, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victor Turrado-Rodriguez, MD (+34690248236, turrado@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Surgery (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04185116, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021; AzTrials last refreshed its copy on 28 Oct 2026.