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Validation of 3 Dimensional Laparoscopic System in Disral Pancreatectomy and Splenectomy

NCT02757690 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-05-02

No results posted yet for this study

Summary

Traditionally, laparoscopy has been based on 2-dimensional (2D) imaging, which has represented a considerable challenge for those approaching this technique. Thus, 3-dimensional (3D) visualization technology for laparoscopy has been proposed, since the early 1990s, as a way to facilitate laparoscopic performance. However, early 3D laparoscopic technology was limited in terms of image quality, so that its use had not been implemented. More recently, industry has developed novel 3D systems where the imaging is similar to stereoscopic vision, in which the depth perception is achieved by different unique images received by each eye. Thus, more recent studies have suggested a possible advantage provided by these new 3D systems during laparoscopic performance. However, comparative assessments of new generation 3D vs 2D laparoscopy remain limited, especially in the hepatobiliary and pancreatic field.

To assess the benefits and harms of use of three dimensional systems versus two dimensional systems during laparoscopic distal pancreatectomy.

Conditions

  • Benign Neoplasm of Body of Pancreas
  • Benign Neoplasm of Tail of Pancreas

Interventions

DEVICE

3-dimensional distal pancreatectomy

3D laparoscopy

DEVICE

2-dimensional distal pancreatectomy

2D laparoscopy

Sponsors & Collaborators

  • Olympus

    collaborator INDUSTRY

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Songcheol Kim, MD PhD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-02-29
Completion
2016-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02757690 on ClinicalTrials.gov