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

University of Palermo

Status and phase: Completed; Phase 4

Conditions: Adrenal Mass; Adrenal Gland Neoplasms; Adrenal Adenoma

Treatments: Procedure: laparoscopic adrenalectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06576336

3D is better

Details and patient eligibility

About

Comparison between 2D traditional laparoscopic surgery and 3D laparoscopy for adrenal surgery.

Full 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.

Enrollment: 350 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients competent to give consent
• aged between 18 and 85 years
• functioning and not functioning benign adrenal lesions,
• adrenal malignancies candidate to laparoscopic adrenal surgery.

Exclusion criteria

• open adrenal surgery
• preoperative signs of local periadrenal invasiveness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

2D group

Active Comparator group

Description:

patients underwent to 2D laparoscopic adrenalectomy for adrenal mass.

Treatment:

Procedure: laparoscopic adrenalectomy

3D group

Experimental group

Description:

patients underwent to 3D laparoscopic adrenalectomy for adrenal mass.

Treatment:

Procedure: laparoscopic adrenalectomy