Adrenal TumorNCT04905706
3D Laparoscopic Adrenalectomies for Adrenal Tumors
An observational study of Adrenal Tumor and Adrenalectomy; Status, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenal Tumor, Adrenalectomy; Status
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2013to 31 Dec 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Dr. Josep Trueta de Girona
Girona, Girona, 17007
José Ignacio Rodríguez-Hermosa, MD, PhD, 972940256, jirodriguez.girona.ics@gencat.cat
About this study
Official title: Three-dimensional Laparoscopic Adrenalectomies for Benign and Malignant Adrenal Tumors
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.
Read the detailed description
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.
- Conditions
- Adrenal Tumor, Adrenalectomy; Status
- Keywords
- Three-dimensional laparoscopy, Adrenal tumors, 3D laparoscopic adrenalectomy
- Medical subject headings
- Adrenal Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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) .
Measured: Up to 4 weeks
Secondary outcomes (12)
Conversion rate trough 3D laparoscopic adrenalectomy
Conversion to open surgery (Yes vs No).
Measured: Intraoperatively
Intraoperative bleeding during 3D laparoscopic adrenalectomy
Blood loss during surgery (millilitres)
Measured: Intraoperatively
Operative time trough 3D laparoscopic adrenalectomy
Duration of intervention (minutes)
Measured: Intraoperatively
Routine use of abdominal drainage in 3D laparoscopic adrenalectomy
Use of abdominal drainage intraoperatively (Yes vs No).
Measured: Intraoperatively
Comparison of morbidity between obese and non obese patients operated by 3D laparoscopic system
No obese: <30 kg/m2 Obese: ≥30 kg/m2
Measured: 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).
Measured: Within 30 days after surgery
Comparison of morbidity between elderly and young patients operated by 3D laparoscopic system
Young <65 years, Elderly ≥65 years
Measured: 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
Measured: 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
Measured: 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)
Measured: Within 30 days after surgery
Comparison of adrenal mass laterality operated by 3D laparoscopic system
Right adrenal mass, left adrenal mass
Measured: 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
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Jan 2013
- Primary completion30 Nov 2033 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Ignacio Rodríguez-Hermosa, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905706
- Sponsor's protocol ID
- 2020.141
- Status last verified
- May 2025
- First submitted
- 14 May 2021
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Laparoscopic Adrenalectomies for Benign and Malignant Adrenal Tumors
- ClinicalTrials.gov ID
- NCT04905706
- Acronym / sponsor ID
- 2020.141
- Conditions
- Adrenal Tumor, Adrenalectomy; Status
- Keywords
- Three-dimensional laparoscopy, Adrenal tumors, 3D laparoscopic adrenalectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Nov 2033 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative complications rate of 3D laparoscopic adrenalectomy
Time frame: Within 30 days after surgery
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.
Length of hospital stay
Time frame: Up to 4 weeks
Total length of hospital stay will be recorded in days beginning at admission for surgery until discharge (number of days) .
12 secondary outcomes
Conversion rate trough 3D laparoscopic adrenalectomy
Time frame: Intraoperatively
Intraoperative bleeding during 3D laparoscopic adrenalectomy
Time frame: Intraoperatively
Operative time trough 3D laparoscopic adrenalectomy
Time frame: Intraoperatively
Routine use of abdominal drainage in 3D laparoscopic adrenalectomy
Time frame: Intraoperatively
Comparison of morbidity between obese and non obese patients operated by 3D laparoscopic system
Time frame: Within 30 days after surgery
Comparison of morbidity in patients with prior abdominal surgery versus non operated by 3D laparoscopic system
Time frame: Within 30 days after surgery
Comparison of morbidity between elderly and young patients operated by 3D laparoscopic system
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
Time frame: Within 30 days after surgery
Comparison of morbidity between adrenal mass size <6 cm versus ≥6 cm operated by 3D laparoscopic system
Time frame: Within 30 days after surgery
Comparison of adrenal mass diagnosis operated by 3D laparoscopic system
Time frame: Within 30 days after surgery
Comparison of adrenal mass laterality operated by 3D laparoscopic system
Time frame: Within 30 days after surgery
Comparison of morbidity between 2D versus 3D laparoscopic system
Time frame: Within 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Tumor and Adrenalectomy; Status, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact José Ignacio Rodríguez-Hermosa, MD, PhD (+34 972 94 02 56, jirodriguez.girona.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications rate of 3D laparoscopic adrenalectomy (time frame: Within 30 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.