- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02841657
3D Laparoscopy Versus 2D Laparoscopy (Lap3D)
3D vs 2D Colorectal Resections and Valuation of Visual Load of Surgeons
- 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.
Study Overview
Status
Conditions
Detailed Description
3 Dimensional (3D) Camera system is a new technique introduced into laparoscopic surgery field, adding the depth perception. Even if in the first 2000' the old 3D camera had negative results in terms of quality of images, thanks to technological progress the new 3D systems have reached high quality.
This new technology has been widely tested in pelvic trainer, not yet in live surgery. Moreover effects on surgeons visual work load are unknown.
Aim of the present study is to evaluate the potential superiority of 3D laparoscopic technique on 2D one in terms on postoperative complications and oncological radicality (in case of neoplastic disease).
Secondary aim is to study the possible major visual stress on surgeons brain caused by 3D camera rather than 2D videos.
ENROLLMENT All patients affected by neoplastic or inflammatory colorectal disease are enrolled in the study.
Preoperative, intraoperative e postoperative data are collected dividing all the patients according the camera system used during the operation: 2D group vs 3D group.
Preoperative data: sex, age, date of birth, id, date of admission, past medical history Intraoperative data: date of surgery, pathology, site of pathology, type of surgery and duration, intraoperative blood loss, other intraoperative problems, loop ileostomy, colostomy, drain positioning, intensive care unit admission Postoperative data (at 30th postoperative day): complications according to Dindo-Clavien scale (Dindo-Clavien classification of surgical complications), type of complications, transfusion, reoperation, other treatments, histology specimen report.
At the end of every operation, the 1st surgeon has to fill in the NASA (The National Aeronautics and Space Administration) task load index and the Simulator Sickness questionnaire.
Number of participants: 350 Years necessary: 2
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Marco Inama, MD PhDs
- Phone Number: +39 0456449319
- Email: inama.marco@gmail.com
Study Contact Backup
- Name: Gianluigi Moretto, MD
- Phone Number: +39 0456449319
- Email: g_moretto@libero.it
Study Locations
-
-
Verona
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Peschiera del Garda, Verona, Italy, 39100
- Recruiting
- Hospital "Dott. Pederzoli"
-
Contact:
- Marco Inama, MD, PhDs
- Email: inama.marco@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- colorectal cancer with or without preoperative radio e chemiotherapy
- inflammatory bowel disease affected colon and rectum that need surgery
Exclusion Criteria:
- patients under 18 years
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative complications
Time Frame: through study completion, an average of 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oncological radicality
Time Frame: through study completion, an average of 2 years
|
The R0/R1 rate is evaluate in patients undergone to 3 dimensional or 2 dimensional laparoscopic colorectal surgery.
|
through study completion, an average of 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marco Inama, MD PhDs, Hospital "Dott. Pederzoli"
Publications and helpful links
General Publications
- 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.
- Sinha 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.
- Shakir 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.
- Sakata 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.
- Usta 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.
- 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.
- Ashraf 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.
- Ko 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.
- Smith 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.
- 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.
- Marcus 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3Dvs2D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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