The main drawbacks of conventional 2D laparoscopy are limited depth perception and loss of spatial orientation. High-quality 3D laparoscopy systems might improve surgical outcomes for adrenalectomy.
Over recent decades, technological advances such as improved video imaging (high-definition cameras), better instrumentation for dissection and hemostasis, articulating staplers, and optimized operating room lighting have added safety, efficacy, and precision to minimally invasive procedures. However, until recently, laparoscopy required surgeons to operate in a three-dimensional (3D) space with only two-dimensional (2D) images to guide their movements, resulting in a lack of depth perception and loss of spatial orientation that increased the risk of errors, fatigue, operative time, and operating room stress and made the technique difficult to learn. High-quality 3D laparoscopy was developed as an alternative to conventional 2D laparoscopy. Several clinical trials and observational studies have compared surgical outcomes between 2D and 3D laparoscopic systems; however, few clinical studies have examined the usefulness of 3D laparoscopy systems for adrenalectomies.
Study Type
OBSERVATIONAL
Enrollment
300
Hospital Universitari Dr. Josep Trueta de Girona
Girona, Girona, Spain
RECRUITINGPostoperative complications rate of 3D laparoscopic adrenalectomy
Rate of medical and surgical complications within 30 days after surgery using the Dindo-Clavien classification, described as: Grade I = Any deviation from the normal postoperative course. Grade 2 = Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III = Requiring surgical, endoscopic or radiological intervention, not under (Grade IIIa) or under general anesthesia (Grade IIIb) Grade IV = Life-threatening complication with single organ (Grade IVa) or Multiorgan dysfunction (Grade IVb) Grade V = Death of a patient.
Time frame: Within 30 days after surgery
Length of hospital stay
Total length of hospital stay will be recorded in days beginning at admission for surgery until discharge (number of days) .
Time frame: Up to 4 weeks
Conversion rate trough 3D laparoscopic adrenalectomy
Conversion to open surgery (Yes vs No).
Time frame: Intraoperatively
Intraoperative bleeding during 3D laparoscopic adrenalectomy
Blood loss during surgery (millilitres)
Time frame: Intraoperatively
Operative time trough 3D laparoscopic adrenalectomy
Duration of intervention (minutes)
Time frame: Intraoperatively
Routine use of abdominal drainage in 3D laparoscopic adrenalectomy
Use of abdominal drainage intraoperatively (Yes vs No).
Time frame: Intraoperatively
Comparison of morbidity between obese and non obese patients operated by 3D laparoscopic system
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No obese: \<30 kg/m2 Obese: ≥30 kg/m2
Time frame: Within 30 days after surgery
Comparison of morbidity in patients with prior abdominal surgery versus non operated by 3D laparoscopic system
Prior abdominal surgery (Yes vs No).
Time frame: Within 30 days after surgery
Comparison of morbidity between elderly and young patients operated by 3D laparoscopic system
Young \<65 years, Elderly ≥65 years
Time frame: Within 30 days after surgery
Comparison of morbidity between American Society of Anesthesiologists I+II and III+IV operated by 3D laparoscopic system
ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes
Time frame: Within 30 days after surgery
Comparison of morbidity between adrenal mass size <6 cm versus ≥6 cm operated by 3D laparoscopic system
Adrenal mass \<6 cm, Adrenal mass ≥6 cm
Time frame: Within 30 days after surgery
Comparison of adrenal mass diagnosis operated by 3D laparoscopic system
Incidentaloma, Aldosteronoma, Pheochromocytoma, Cushing's Adenoma and malignant adrenal tumors (primary or metastasis)
Time frame: Within 30 days after surgery
Comparison of adrenal mass laterality operated by 3D laparoscopic system
Right adrenal mass, left adrenal mass
Time frame: Within 30 days after surgery
Comparison of morbidity between 2D versus 3D laparoscopic system
Conversion (Yes vs No), operative time (min), bleeding (ml), Clavien-Dindo Classification
Time frame: Within 30 days after surgery