Adrenal Adenoma, Adrenal Gland Neoplasms, Adrenal Mass
Conditions
Keywords
adrenal surgery, laparoscopic adrenalectomy
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.
Interventions
PROCEDURElaparoscopic adrenalectomy
laparoscopic adrenalectomy
Sponsors
University of Palermo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| periperative surgical outcomes | 30-postoperative days | evaluation of intraoperative surgical complication during laparoscopic adrenalectomy with YES or NO and questionnaire about resolution of complications. In details the investigators evaluates: vascular complications (Major lesions: renal artery, renal vein; aorta; vena cava; sovrahepatic veins. Minor lesions: adrenal vessels; accessory renal vessels; others); complication hollow viscus (bowel; colonic; stomach; urether); complication parenchymatous viscus (renal; adrenal; spleen; diaphragm); resolution of complications; conversion to open surgery. 30-day postoperative complications (only grade 3 - 4 - 5 sec. Clavien-Dindo classification) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| definition of surgical plane | intraoperatory time | definition of surgical plane during surgery with a questionnaire administered to surgical team with a score from 1 (min definition) to 5 (max definition) |
| evaluation of surgical strain | intraoperatory time | variables of surgical strain: wrist, hand, neck, back, dizziness and/or headache (Yes=1; No=0). |
| depth perception | intraoperatory time | evaluation of depth perception during surgical procedure with a questionnaire administered to surgical team with a score from 1 (min depth) to 5 (max depth) |
Countries
Italy
Outcome results
None listed