Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576336
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-17
Brief Title:
A Randomized Clinical Trial About Use of 3D Laparoscopy Versus 2D Laparoscopy in Adrenal Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
3D is Better for Adrenal a Randomized Clinical Trial About Use of 3D Laparoscopy Versus 2D Laparoscopy in Adrenal Surgery
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
3DAdrenal
Brief Summary:
Comparison between 2D traditional laparoscopic surgery and 3D laparoscopy for adrenal surgery
Detailed Description:
Laparoscopic adrenalectomy is today considered the gold standard of treatment for adrenal tumors This technique was described for the first time by Gagner in 1992 and in the past years several studies have shown the advantages of laparoscopic approach with decrease of the perioperative morbidity lower complication rates less operative blood loss less postoperative pain and shorter hospital stay compared with open adrenalectomy Laparoscopic surgery is more difficult to learn and requires different psychomotor skills than open laparotomy In fact the surgeons have to work in a three-dimensional space but are guided by two-dimensional images The development of high definition cameras does not eliminate the major limitation of two-dimensional 2D laparoscopy lack of depth perception and lose of spatial orientation with potential increasing the strain for the surgeon the risk of errors and the operative time Three-dimensional 3D HD laparoscopy was developed as an alternative to conventional 2D laparoscopy
In literature there are still few clinical studies on use of 3D in laparoscopic adrenalectomies with different results
For these reasons the investigators propose an international multicenter study to compare 3D laparoscopic adrenalectomy with standard laparoscopic adrenalectomy
In literature there are still few clinical studies on use of 3D in laparoscopic adrenalectomies with different results
For these reasons the investigators propose an international multicenter study to compare 3D laparoscopic adrenalectomy with standard laparoscopic adrenalectomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None