3D-HD Optic Systems Influence Surgical Performance

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04185116
• Other study ID #: HCB/2018/1203
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2020
• Est. completion date: September 2022

Study information

• Verified date: September 2021
• Source: Hospital Clinic of Barcelona
• Contact: Victor Turrado-Rodriguez, MD
• Phone: +34690248236
• Email: turrado[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 laparoscopic Roux-en-Y gastric bypass.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: September 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fatigue
• Operative Time
• Surgery--Complications

Intervention

Device:
• 3D Optic System (Olympus VISERA Elite II 3D)
Use of the 3D Optic System "Olympus VISERA Elite II 3D"

Locations

Country	Name	City	State
Spain	Victor Turrado-Rodriguez	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (8)

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. — View 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. — View Citation

Bilgen K, Ustün M, Karakahya M, Isik S, Sengül S, Cetinkünar S, Küçükpinar 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. — View Citation

Cuesta-Vargas AI, Férnandez-Lao C, Cantarero-Villanueva I, Castro-Sánchez AM, Fernández-de-Las Peñas 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. — View Citation

Currò 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. — View Citation

Gómez-Gómez E, Carrasco-Valiente J, Valero-Rosa J, Campos-Hernández 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. — View 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. — View Citation

Özsoy 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Surgery	Total time to perform the jejuno-jejunal anastomosis and closure of the mesenteric defect.	Day 1
Secondary	Intraoperative complications	Record of the intraoperative complications that may occur during the procedure (bleeding, bowel injury, mesenteric injury, disruption of the anastomotic suture)	Day 1
Secondary	Profile of Mood States (POMS)	Measurement of self-perceived fatigue using the POMS scale	Day 1
Secondary	Quick Questionnaire Piper Fatigue Scale (QPFS)	Measurement of self-perceived fatigue using QPFS	Day 1
Secondary	Visual Analogue Scale (VAS) - related fatigue	Fatigue measured using the VAS	Day 1
Secondary	Postoperative complications	Classification of the postoperative complications using the Clavien-Dindo Classification	90 days after surgery