3D Laparoscopy Versus 2D Laparoscopy

Colorectal Cancer Clinical Trial

— Lap3D  

Official title:

3D vs 2D Colorectal Resections and Valuation of Visual Load of Surgeons

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02841657
• Other study ID #: 3Dvs2D
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2016
• Last updated: August 4, 2017
• Start date: January 2016
• Est. completion date: October 2017

Study information

• Verified date: August 2017
• Source: Casa di Cura Dott. Pederzoli
• Contact: Marco Inama, MD PhDs
• Phone: +39 0456449319
• Email: inama.marco[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Locations

Country	Name	City	State
Italy	Hospital "Dott. Pederzoli"	Peschiera del Garda	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Casa di Cura Dott. Pederzoli

Country where clinical trial is conducted

Italy, 

References & Publications (11)

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 Sur — View Citation

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: 10.10 — View Citation

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 — View Citation

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. Neurosu — 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

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 — View Citation

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. Review. — View Citation

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. Epub 2016 Apr 8. — View Citation

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. Review. — View Citation

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 201 — View Citation

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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Oncological radicality	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