Benign Neoplasm of Body of Pancreas Clinical Trial
Official title:
Validation and Verification of 3 Dimensional Laparoscopic System in Laparoscopic Distal Pancreatectomy & Splenectomy
| Verified date | April 2016 |
| Source | Asan Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Ministry of Food and Drug Safety |
| Study type | 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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | February 2016 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - BMI > 30 (Kg/m2) - History of severe or recurrent pancreatitis - Mass size > 10cm - History of low abdomen major operation - Additional resection for extra-pancreatic organ Exclusion Criteria: - Participants refusal. - Additional resection dependent on pathological examination in intraoperative or postoperative period. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Asan Medical Center | Olympus |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | expected duration: 200mins (for each operation) | Yes |
| Secondary | Numbers of errors during operation | The investigators will check the error number of operator during operation with review the video record of the operation | During operation (expected duration: 200mins) | Yes |
| Secondary | 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. | During operation (expected duration: 200mins) | No |