Evaluation of 3D Visualization for Total Colectomy
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      The anticipated advantages of 3D laparoscopic visualization for the surgeon are greater
      accuracy and speed in manual skills, translating to decreased operative time, reduced
      learning curve, and superior safety.We aimed to determine the feasibility of the laparoscopic
      approach using 3D visualization in the surgical treatment of ulcerative colitis
    

Detailed description: 
      Three-dimensional (3D) visualization technology for laparoscopy has been proposed, since the
      early 1990's, as a method to facilitate laparoscopic performance. However, early 3D
      laparoscopic technology was limited in terms of image quality, so that its use had not been
      implemented. The latest technical developments ensure high-definition 3D visualization with
      the same quality that current two-dimensional (2D) systems provide.

      The anticipated advantages of 3D laparoscopic visualization for the surgeon are greater
      accuracy and speed in manual skills, translating to decreased operative time, reduced
      learning curve, and superior safety . It was reported that, 3D laparoscopic visualization
      offers significant advantages in enhancing laparoscopic performance, even in novice surgeons,
      comparing to the 2D systems . We hypothesize that 3D visualization may allow surgeons to
      reduce the overall operating time with a rate of 10% with comparable perioperative and
      postoperative outcomes. The primary endpoint of this study is to determine the feasibility of
      the laparoscopic approach using 3D visualization in the surgical treatment of ulcerative
      colitis. Secondary endpoints are to determine whether 3D visualization confers benefits such
      as reduced operating time and intra-operative complications with comparable postoperative
      outcomes.

      Device Description: The EXERA III Universal Platform will be used in this study, in
      conjunction with the ENDOEYE FLEX 3D. The ENDOEYE FLEX 3D can also be used in 2D mode, by
      utilizing a programmed button on the handle of the scope, or by using the 2D/3D button on the
      3D Visualization Unit. The articulating tip of the ENDOEYE FLEX allows for the scope to be
      used in both single-site and multi-port procedures, providing critical views and allowing a
      bird's eye view so that the scope is out of the way of other instruments (while still
      capturing the image at the surgical site). All equipment used in this trial has been cleared
      under 510(k) approval by the FDA, and has been on the market in the US since April 2013.

      The Olympus HD 3D Laparoscopic Surgical Video System consists of the following components:

        -  CV-190 Processor

        -  CLV-190 Light Source

        -  3DV-190 3D Visualization Unit

        -  LMD-2451MT/3G4 Sony 24" 3D Monitor

        -  IMH-20 Image Capture System

        -  UHI-4 Insufflator

        -  K10021611 Cart

        -  OL-0015-08 Tall Rollstand

        -  LTF-190-10-3D ENDOEYE FLEX 3D Videoscope

        -  3D glasses (regular and clip-on styles)

      Study Size:Mean operating time for laparoscopic subtotal colectomy for medically refractory
      UC was reported longer with a comparison to open surgery in the recently published studies.

      Therefore the effort to decrease operating time in laparoscopic colectomy has gained
      importance. We assumed that, in order to be able to determine a 10% reduction in mean
      operating time, each group should include 27 patients (80% power and 5% significance).

      Patients who will undergo laparoscopic total abdominal colectomy (TAC) for UC will be
      included in the study. All subjects will be randomized into two groups: 3D laparoscopy, and
      2D laparoscopy. Three staff surgeons (EG, HK, FR) at the department of colorectal surgery,
      Cleveland Clinic, Ohio will perform the procedures with 2D and 3D laparoscopy. Each surgeon
      will perform 9 total colectomies with 3D, and 9 total colectomies with the 2D laparoscopy
      system. In total, 54 patients will be included (27 patients for each group).
    

Intervention name(s): 3-dimensional visualization; 2-dimensional visualization
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode; Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment