Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
102 participants
INTERVENTIONAL
2020-02-12
2022-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy on a Virtual Reality Simulator
NCT01615549
Comparison of 2-Dimensional and 3-Dimensional Laparoscopic Visions
NCT01799577
Image Fusion in the OR
NCT03670849
Validation of 3 Dimensional Laparoscopic System in Disral Pancreatectomy and Splenectomy
NCT02757690
2D Versus 3D Laparoscopic Training on a Virtual Reality Simulator
NCT02361463
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
3D Optic Surgeons
Full-trained surgeons randomised into this interventional arm will be performing laparoscopic gastric bypass using a 3D optic system.
3D Optic System (Olympus VISERA Elite II 3D)
Use of the 3D Optic System "Olympus VISERA Elite II 3D"
2D Optic Surgeons
Full-trained surgeons randomised into this interventional arm will be performing laparoscopic gastric bypass using a 2D optic system.
No interventions assigned to this group
3D Optic Residents
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 System (Olympus VISERA Elite II 3D)
Use of the 3D Optic System "Olympus VISERA Elite II 3D"
2D Optic Residents
4th and 5th year General Surgery residentes randomised into this interventional arm will be performing laparoscopic gastric bypass using a 2D optic system.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
3D Optic System (Olympus VISERA Elite II 3D)
Use of the 3D Optic System "Olympus VISERA Elite II 3D"
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Laparoscopic Gastric Bypass candidates
Exclusion Criteria
* Candidates to other surgical procedures than laparoscopic gastric bypass
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Clinic of Barcelona
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Víctor Turrado-Rodríguez
Gastrointestinal Surgeon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Victor Turrado-Rodriguez
Barcelona, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HCB/2018/1203
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.