NCT06576336

A Randomized Clinical Trial About Use of 3D Laparoscopy Versus 2D Laparoscopy in Adrenal Surgery

3D is Better for Adrenal: a Randomized Clinical Trial About Use of 3D Laparoscopy Versus 2D Laparoscopy in Adrenal Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: University of Palermo · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adrenal Mass
• Adrenal Adenoma
• Adrenal Gland Neoplasms

Interventions

Type	Name	Description
PROCEDURE	laparoscopic adrenalectomy	laparoscopic adrenalectomy

Timeline

• Start date: 2018-01-01
• Primary completion: 2023-12-31
• Completion: 2024-06-30
• First posted: 2024-08-28
• Last updated: 2024-08-28

Locations

2 sites across 1 country: Italy