3D Laparoscopy Versus 2D Laparoscopy
Lap3D
3D vs 2D Colorectal Resections and Valuation of Visual Load of Surgeons
1 other identifier
observational
350
1 country
1
Brief Summary
- To compare surgical and oncological outcomes in patients underwent to colorectal resection with 3D vs 2D laparoscopic technique.
- To evaluate the visual overload in surgeons using 3D laparoscopic technique.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 18, 2016
CompletedFirst Posted
Study publicly available on registry
July 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedAugust 7, 2017
August 1, 2017
1.8 years
July 18, 2016
August 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative complications
The postoperative course is evaluate in all patients undergone to colorectal laparoscopic surgery and classified according to the Dindo-Clavien scale at 30 days after surgery (Dindo-Clavien classification of surgical classification).
through study completion, an average of 2 years
Secondary Outcomes (1)
Oncological radicality
through study completion, an average of 2 years
Eligibility Criteria
All patients affected by neoplastic and inflammatory disease of colorectal tract can be enrolled in the study.
You may qualify if:
- colorectal cancer with or without preoperative radio e chemiotherapy
- inflammatory bowel disease affected colon and rectum that need surgery
You may not qualify if:
- patients under 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital "Dott. Pederzoli"
Peschiera del Garda, Verona, 39100, Italy
Related Publications (11)
Poudel S, Kurashima Y, Watanabe Y, Ebihara Y, Tamoto E, Murakami S, Nakamura T, Tsuchikawa T, Okamura K, Shichinohe T, Hirano S. Impact of 3D in the training of basic laparoscopic skills and its transferability to 2D environment: a prospective randomized controlled trial. Surg Endosc. 2017 Mar;31(3):1111-1118. doi: 10.1007/s00464-016-5074-8. Epub 2016 Jun 28.
PMID: 27351662RESULTSinha RY, Raje SR, Rao GA. Three-dimensional laparoscopy: Principles and practice. J Minim Access Surg. 2017 Jul-Sep;13(3):165-169. doi: 10.4103/0972-9941.181761.
PMID: 27143695RESULTShakir F, Jan H, Kent A. 3D straight-stick laparoscopy versus 3D robotics for task performance in novice surgeons: a randomised crossover trial. Surg Endosc. 2016 Dec;30(12):5380-5387. doi: 10.1007/s00464-016-4893-y. Epub 2016 Apr 8.
PMID: 27059971RESULTSakata S, Watson MO, Grove PM, Stevenson AR. The Conflicting Evidence of Three-dimensional Displays in Laparoscopy: A Review of Systems Old and New. Ann Surg. 2016 Feb;263(2):234-9. doi: 10.1097/SLA.0000000000001504.
PMID: 26501704RESULTUsta TA, Gundogdu EC. The role of three-dimensional high-definition laparoscopic surgery for gynaecology. Curr Opin Obstet Gynecol. 2015 Aug;27(4):297-301. doi: 10.1097/GCO.0000000000000189.
PMID: 26107783RESULTOzsoy 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: 25772250RESULTAshraf A, Collins D, Whelan M, O'Sullivan R, Balfe P. Three-dimensional (3D) simulation versus two-dimensional (2D) enhances surgical skills acquisition in standardised laparoscopic tasks: a before and after study. Int J Surg. 2015 Feb;14:12-6. doi: 10.1016/j.ijsu.2014.12.020. Epub 2015 Jan 2.
PMID: 25560749RESULTKo JK, Li RH, Cheung VY. Two-dimensional versus three-dimensional laparoscopy: evaluation of physicians' performance and preference using a pelvic trainer. J Minim Invasive Gynecol. 2015 Mar-Apr;22(3):421-7. doi: 10.1016/j.jmig.2014.11.007. Epub 2014 Nov 21.
PMID: 25461685RESULTSmith R, Schwab K, Day A, Rockall T, Ballard K, Bailey M, Jourdan I. Effect of passive polarizing three-dimensional displays on surgical performance for experienced laparoscopic surgeons. Br J Surg. 2014 Oct;101(11):1453-9. doi: 10.1002/bjs.9601. Epub 2014 Aug 18.
PMID: 25131843RESULTAlaraimi 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: 25002241RESULTMarcus HJ, Hughes-Hallett A, Cundy TP, Di Marco A, Pratt P, Nandi D, Darzi A, Yang GZ. Comparative effectiveness of 3-dimensional vs 2-dimensional and high-definition vs standard-definition neuroendoscopy: a preclinical randomized crossover study. Neurosurgery. 2014 Apr;74(4):375-80; discussion 380-1. doi: 10.1227/NEU.0000000000000249.
PMID: 24220007RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Inama, MD PhDs
Hospital "Dott. Pederzoli"
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- General Surgeon
Study Record Dates
First Submitted
July 18, 2016
First Posted
July 22, 2016
Study Start
January 1, 2016
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
August 7, 2017
Record last verified: 2017-08