3D-HD Optic Systems Influence Surgical Performance

NCT04185116 | Unknown

• 1 other identifier: HCB/2018/1203
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Operative Time; Fatigue; Surgery--Complications

Keywords

3D optic systems; Fatigue; Length of surgery; 3D laparoscopy; Intraoperative complications; Bariatric and metabolic surgery

Outcome Measures

Primary Outcomes (1)

• Duration of Surgery

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

  Day 1

Secondary Outcomes (5)

• Intraoperative complications

  Day 1

• Profile of Mood States (POMS)

  Day 1

• Quick Questionnaire Piper Fatigue Scale (QPFS)

  Day 1

• Visual Analogue Scale (VAS) - related fatigue

  Day 1

• Postoperative complications

  90 days after surgery

Study Arms (4)

3D Optic Surgeons

EXPERIMENTAL

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

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.

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.

Interventions

3D Optic System (Olympus VISERA Elite II 3D) DEVICE

Use of the 3D Optic System "Olympus VISERA Elite II 3D"

3D Optic Residents; 3D Optic Surgeons

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Victor Turrado-Rodriguez

Barcelona, 08036, Spain

RECRUITING

Related Publications (8)

• 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.

  PMID: 25457567 BACKGROUND

• 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.

  PMID: 25002241 BACKGROUND

• 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.

  PMID: 22721451 BACKGROUND

• 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.

  PMID: 25772250 BACKGROUND

• 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.

  PMID: 25893652 BACKGROUND

• 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.

  PMID: 23579515 BACKGROUND

• 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.

  PMID: 20480710 BACKGROUND

• 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.

  PMID: 23320955 BACKGROUND

MeSH Terms

Conditions

Fatigue; Intraoperative Complications

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Central Study Contacts

Victor Turrado-Rodriguez, MD

CONTACT

+34690248236; turrado@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastrointestinal Surgeon

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: December 4, 2019
• Study Start: February 12, 2020
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

ES (1)