Validation of 3 Dimensional Laparoscopic System in Disral Pancreatectomy and Splenectomy
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|ClinicalTrials.gov Identifier: NCT02757690|
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : May 2, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Benign Neoplasm of Body of Pancreas Benign Neoplasm of Tail of Pancreas||Device: 3-dimensional distal pancreatectomy Device: 2-dimensional distal pancreatectomy||Phase 4|
- the investigators will take the patient consent for this clinical trial.
- The participants will be divided with two groups with block randomized method
- Skillful pancreatic surgeon will perform 2D or 3D laparoscopic distal pancreatectomy.
- The participants will be monitor the intraoperative and postoperative course.
operation video : operation time, number of errors (missed grasp, loss of material)
- Segmental operation time according to procedure
- Numbers of errors during operation
- Blood examination : complete blood count (hemoglobin, white blood cell count), amylase, lipase, etc.
- Radiological examination: X-ray, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), etc
- Medical records : hospital stay after operation, the time to eating, pathologic examination
Subjective scoring in the view of operator, 1st assist.
- Scoring for imaging quality
- Scoring for harms of 3D/2D laparoscopic system
- Scoring for overall demand
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Validation and Verification of 3 Dimensional Laparoscopic System in Laparoscopic Distal Pancreatectomy & Splenectomy|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Active Comparator: 2-dimenasional distal pancreatectomy
device: 2 dimensional laparoscopy of Olympus
Device: 2-dimensional distal pancreatectomy
Other Name: 2D
Experimental: 3-dimenasional distal pancreatectomy
device : 3 dimensional laparoscopy of Olympus
Device: 3-dimensional distal pancreatectomy
Other Name: 3D
- Operation time [ Time Frame: expected duration: 200mins (for each operation) ]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.
- Numbers of errors during operation [ Time Frame: During operation (expected duration: 200mins) ]The investigators will check the error number of operator during operation with review the video record of the operation
- Subjective scoring in the view of operator, 1st assist [ Time Frame: During operation (expected duration: 200mins) ]The investigators will check the subjective scoring of operator and 1st assist during operation. For example, depth perception, sharpness, visual strain, headache, etc.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757690
|Principal Investigator:||Songcheol Kim, MD PhD||Asan Medical Center|