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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04185116
Other study ID # HCB/2018/1203
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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