Adrenal MassPhase 43DAdrenalNCT06576336
A Randomized Clinical Trial About Use of 3D Laparoscopy Versus 2D Laparoscopy in Adrenal Surgery
A Phase 4 study testing laparoscopic adrenalectomy in people with Adrenal Mass and Adrenal Adenoma, run by University of Palermo at 2 sites in Italy.
Trial summary
Comparison between 2D traditional laparoscopic surgery and 3D laparoscopy for adrenal surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Adrenal Mass, Adrenal Adenoma, Adrenal Gland Neoplasms
- What is being tested?
- laparoscopic adrenalectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jan 2018to 30 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients competent to give consent
- aged between 18 and 85 years
- functioning and not functioning benign adrenal lesions,
- adrenal malignancies candidate to laparoscopic adrenal surgery.
Who cannot join
- open adrenal surgery
- preoperative signs of local periadrenal invasiveness
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 3D is Better for Adrenal: a Randomized Clinical Trial About Use of 3D Laparoscopy Versus 2D Laparoscopy in Adrenal Surgery
Comparison between 2D traditional laparoscopic surgery and 3D laparoscopy for adrenal surgery.
Read the detailed description
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.
- Conditions
- Adrenal Mass, Adrenal Adenoma, Adrenal Gland Neoplasms
- Being tested
- laparoscopic adrenalectomy
- Keywords
- adrenal surgery, laparoscopic adrenalectomy
- Medical subject headings
- ACTH Syndrome, Ectopic, Adrenal Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic adrenalectomyProcedure or surgery
laparoscopic adrenalectomy
| Study group | Role | What they receive |
|---|---|---|
| 2D group | Active comparator | patients underwent to 2D laparoscopic adrenalectomy for adrenal mass. Receives: Procedure: laparoscopic adrenalectomy |
| 3D group | Experimental | patients underwent to 3D laparoscopic adrenalectomy for adrenal mass. Receives: Procedure: laparoscopic adrenalectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
periperative surgical outcomes
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)
Measured: 30-postoperative days
Secondary outcomes (3)
depth perception
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)
Measured: intraoperatory time
definition of surgical plane
definition of surgical plane during surgery with a questionnaire administered to surgical team with a score from 1 (min definition) to 5 (max definition)
Measured: intraoperatory time
evaluation of surgical strain
variables of surgical strain: wrist, hand, neck, back, dizziness and/or headache (Yes=1; No=0).
Measured: intraoperatory time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adrenal MassStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Antonino Agrusa, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576336
- Sponsor's protocol ID
- 3D is better
- Acronym
- 3DAdrenal
- Status last verified
- Aug 2024
- First submitted
- 17 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: databse is in the possession of the corresponding author and available upon request after publication of research.
Publications
Agrusa A, di Buono G, Chianetta D, Sorce V, Citarrella R, Galia M, Vernuccio L, Romano G, Gulotta G. Three-dimensional (3D) versus two-dimensional (2D) laparoscopic adrenalectomy: A case-control study. Int J Surg. 2016 Apr;28 Suppl 1:S114-7. doi: 10.1016/j.ijsu.2015.12.055. Epub 2015 Dec 18.
PubMed 26708842
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D is Better for Adrenal: a Randomized Clinical Trial About Use of 3D Laparoscopy Versus 2D Laparoscopy in Adrenal Surgery
- ClinicalTrials.gov ID
- NCT06576336
- Acronym / sponsor ID
- 3DAdrenal / 3D is better
- Conditions
- Adrenal Mass, Adrenal Adenoma, Adrenal Gland Neoplasms
- Keywords
- adrenal surgery, laparoscopic adrenalectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 28 Aug 2024 (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.
Comparison between 2D traditional laparoscopic surgery and 3D laparoscopy for adrenal surgery.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2D group | Active comparator | Procedure: laparoscopic adrenalectomypatients underwent to 2D laparoscopic adrenalectomy for adrenal mass. |
| 3D group | Experimental | Procedure: laparoscopic adrenalectomypatients underwent to 3D laparoscopic adrenalectomy for adrenal mass. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients competent to give consent
- aged between 18 and 85 years
- functioning and not functioning benign adrenal lesions,
- adrenal malignancies candidate to laparoscopic adrenal surgery.
Key exclusion criteria (2 listed)
- open adrenal surgery
- preoperative signs of local periadrenal invasiveness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic adrenalectomylaparoscopic adrenalectomy | Procedure or surgery | 2D group, 3D group |
Primary outcome
periperative surgical outcomes
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)
3 secondary outcomes
depth perception
Time frame: intraoperatory time
definition of surgical plane
Time frame: intraoperatory time
evaluation of surgical strain
Time frame: intraoperatory time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Results publication: PubMed 26708842Agrusa A, di Buono G, Chianetta D, Sorce V, Citarrella R, Galia M, Vernuccio L, Romano G, Gulotta G. Three-dimensional (3D) versus two-dimensional (2D) laparoscopic adrenalectomy: A case-control study. Int J Surg. 2016 Apr;28 Suppl 1:S114-7. doi: 10.1016/j.ijsu.2015.12.055. Epub 2015 Dec 18.
- Individual participant dataSharing planned: No. databse is in the possession of the corresponding author and available upon request after publication of research.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing laparoscopic adrenalectomy in people with Adrenal Mass and Adrenal Adenoma, run by University of Palermo at 2 sites in Italy.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
periperative surgical outcomes (time frame: 30-postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06576336, which also lists 1 linked publication.
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 28 Aug 2024.