A Phase 4 interventional study of 3-dimensional distal pancreatectomy and 2-dimensional distal pancreatectomy in Benign Neoplasm of Body of Pancreas and Benign Neoplasm of Tail of Pancreas, sponsored by Asan Medical Center. Completed. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-05-02.
Sponsored by Asan Medical Center · Phase 4 and Interventional
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.
Procedures
Data collection
operation video : operation time, number of errors (missed grasp, loss of material)
clinical parameters:
Subjective scoring in the view of operator, 1st assist.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
device: 2 dimensional laparoscopy of Olympus
Device: 2-dimensional distal pancreatectomy
device : 3 dimensional laparoscopy of Olympus
Device: 3-dimensional distal pancreatectomy
3D laparoscopy
Also known as: 3D
2D laparoscopy
Also known as: 2D
Operation time
The unedited videos of the operations will be assessed from start to end of the operation by two clinicians. The average of operation time will be compare according to 2D versus 3D laparoscopic system.
Time frame: expected duration: 200mins (for each operation)
Numbers of errors during operation
The investigators will check the error number of operator during operation with review the video record of the operation
Time frame: During operation (expected duration: 200mins)
Subjective scoring in the view of operator, 1st assist
The investigators will check the subjective scoring of operator and 1st assist during operation. For example, depth perception, sharpness, visual strain, headache, etc.
Time frame: During operation (expected duration: 200mins)
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Asan Medical Center