3D Laparoscopy Versus 2D Laparoscopy — Lap3D  

Colorectal Cancer Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

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

• NCT number: NCT02841657
• Study type: Observational
• Source: Casa di Cura Dott. Pederzoli
• Contact: Marco Inama, MD PhDs
• Phone: +39 0456449319
• Email: inama.marco@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: January 2016
• Completion date: October 2017