Clinical trial NCT06576336: A Randomized Clinical Trial About Use of 3D Laparoscopy Versus 2D Laparoscopy in Adrenal Surgery
Official title: 3D is Better for Adrenal: a Randomized Clinical Trial About Use of 3D Laparoscopy Versus 2D Laparoscopy in Adrenal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adrenal Mass
Adrenal Adenoma
Adrenal Gland Neoplasms
Keywords: adrenal surgery
laparoscopic adrenalectomy
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: periperative surgical outcomes
timeFrame: 30-postoperative days
Secondary outcomes:
measure: depth perception
timeFrame: intraoperatory time
measure: definition of surgical plane
timeFrame: intraoperatory time
measure: evaluation of surgical strain
timeFrame: intraoperatory time
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Giuseppe Di Buono
state: PA
city: Palermo
country: Italy
facility: Italy
Study officials:
References:
citation: Agrusa A, di Buono G, Chianetta D, Sorce V, Citarrella R, Galia M, Vernuccio L, Romano G, Gulotta G. Three-dimensional (3D) versus two-dimensional (2D) laparoscopic adrenalectomy: A case-control study. Int J Surg. 2016 Apr;28 Suppl 1:S114-7. doi: 10.1016/j.ijsu.2015.12.055. Epub 2015 Dec 18.