3D Laparoscopic Adrenalectomies for Adrenal Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut d'Investigació Biomèdica de Girona Dr. Josep Trueta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All adult patients (age ≥ 18 years)
Patients diagnosed with adrenal masses (benign and malignant tumors)
Underwent a unilateral 3D laparoscopic adrenalectomy from January 2013 to December 2033.
Disqualifiers
Emergency surgery.
Open adrenalectomy.
Bilateral adrenalectomies (open or laparoscopy).
Patients who underwent laparoscopic adrenalectomy together with another laparoscopic surgical procedure in the same intervention.
Trial population
All adult patients (age ≥ 18 years) who underwent a unilateral 3D laparoscopic adrenalectomy for adrenal masses (benign and malignant tumors) from January 2013 to December 2033.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 1 trial groupGroup A: 3D laparoscopic adrenalectomy
Trial outcomes
Primary outcomes
1
Postoperative 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 surgery2
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 weeksSecondary outcomes
1
Conversion rate trough 3D laparoscopic adrenalectomy
Conversion to open surgery (Yes vs No).
Time frame
Intraoperatively2
Intraoperative bleeding during 3D laparoscopic adrenalectomy
Blood loss during surgery (millilitres)
Time frame
Intraoperatively3
Operative time trough 3D laparoscopic adrenalectomy
Duration of intervention (minutes)
Time frame
Intraoperatively4
Routine use of abdominal drainage in 3D laparoscopic adrenalectomy
Use of abdominal drainage intraoperatively (Yes vs No).
Time frame
IntraoperativelySponsors and contacts
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Source ClinicalTrials.gov