laparoscopic adrenalectomy
Procedurelaparoscopic adrenalectomy
NCT Number: NCT06576336
Comparison between 2D traditional laparoscopic surgery and 3D laparoscopy for adrenal surgery.
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Notify Me18 year–85 year
All sexes
Interventional
Phase 4
Giuseppe Di Buono, Palermo, PA, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
laparoscopic adrenalectomy
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: intraoperatory time
variables of surgical strain: wrist, hand, neck, back, dizziness and/or headache (Yes=1; No=0).
University of Palermo
Other
3D is Better for Adrenal: a Randomized Clinical Trial About Use of 3D Laparoscopy Versus 2D Laparoscopy in Adrenal Surgery
Acronym: 3DAdrenal
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