3D Laparoscopic Adrenalectomies for Adrenal Tumors
Three-dimensional Laparoscopic Adrenalectomies for Benign and Malignant Adrenal Tumors
1 other identifier
observational
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 14, 2021
CompletedFirst Posted
Study publicly available on registry
May 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2033
May 9, 2025
May 1, 2025
20.9 years
May 14, 2021
May 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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) .
Up to 4 weeks
Secondary Outcomes (12)
Conversion rate trough 3D laparoscopic adrenalectomy
Intraoperatively
Intraoperative bleeding during 3D laparoscopic adrenalectomy
Intraoperatively
Operative time trough 3D laparoscopic adrenalectomy
Intraoperatively
Routine use of abdominal drainage in 3D laparoscopic adrenalectomy
Intraoperatively
Comparison of morbidity between obese and non obese patients operated by 3D laparoscopic system
Within 30 days after surgery
- +7 more secondary outcomes
Study Arms (1)
3D laparoscopic adrenalectomy
Operations are done with an high definition 3D laparoscopic system (Olympus, Tokyo, Japan); all personnel wear polarized glasses to achieve stereoscopic imaging in the operating room. Dissection is realized using a hybrid energy system (Thunderbeat, Olympus Europe Se \& Co, Hamburg, Germany).
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Emergency surgery.
- Open adrenalectomy.
- Bilateral adrenalectomies (open or laparoscopy).
- Patients who underwent laparoscopic adrenalectomy together with another laparoscopic surgical procedure in the same intervention.
- Patients without complete follow-up for at least 30 days after hospital discharge.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitari Dr. Josep Trueta de Girona
Girona, Girona, 17007, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 14, 2021
First Posted
May 28, 2021
Study Start
January 1, 2013
Primary Completion (Estimated)
November 30, 2033
Study Completion (Estimated)
December 31, 2033
Last Updated
May 9, 2025
Record last verified: 2025-05