Adrenal DiseaseCLARASNCT05322265
Complication in Laparoscopic Renal and Adrenal Surgery (CLARAS)
An observational study of Adrenal Disease and Renal Cancer, run by University of Palermo at 1 site in Italy.
Trial summary
the aim of this study is clarify complication and their resolution in laparoscopic renal and adrenal surgery. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Adrenal Disease, Renal Cancer, Surgery--Complications
- What is being tested?
- laparoscopic surgery for renal and adrenal diseases
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2017to 30 May 2022
- Phase
- Observational
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients underwent to laparoscopic renal and adrenal surgery form april 2017 to march 2022 in several high volume surgical center
Who may be able to join
- renal diseases with indication to surgery adrenal masses
Who cannot join
- open surgery in principle
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Palermo
Palermo, 90127
Giuseppe Di Buono, Medicine, +390916552611, giuseppe.dibuono@unipa.it
Antonino Agrusa, Medicine, +390916552612, antonino.agrusa@unipa.it
About this study
Official title: Complication in Laparoscopic Renal and Adrenal Surgery (CLARAS): an International Multicenter Study
the aim of this study is clarify complication and their resolution in laparoscopic renal and adrenal surgery.
Read the detailed description
the aim of this study is clarify complication and their resolution in laparoscopic renal and adrenal surgery.
- Conditions
- Adrenal Disease, Renal Cancer, Surgery--Complications
- Being tested
- laparoscopic surgery for renal and adrenal diseases
- Keywords
- laparoscopic surgery, renal surgery, adrenalectomy, complication in laparoscopic surgery
- Medical subject headings
- Adrenal Gland Diseases, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic surgery for renal and adrenal diseasesProcedure or surgery
type of treatment for patients underwent to laparoscopic surgery for renal and adrenal diseases with intraoperative complications
| Study group | Role | What they receive |
|---|---|---|
| complicated patients | patients underwent to laparoscopic renal and adrenal surgery with intraoperative complications Receives: Procedure: laparoscopic surgery for renal and adrenal diseases | |
| uncomplicated patients | patients underwent to laparoscopic renal and adrenal surgery with no complication during surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative complications
evaluation of intraoperative complication and their resolution
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Apr 2017
- Primary completion31 Mar 2022
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal DiseaseStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacio Puigvert
- Responsible party
- Principal investigator, Prof. Antonino Agrusa, University of Palermo
- Investigators
- Antonino Agrusa, Medicine, Study director, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322265
- Sponsor's protocol ID
- CLARAS study
- Acronym
- CLARAS
- Status last verified
- Apr 2022
- First submitted
- 3 Apr 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complication in Laparoscopic Renal and Adrenal Surgery (CLARAS): an International Multicenter Study
- ClinicalTrials.gov ID
- NCT05322265
- Acronym / sponsor ID
- CLARAS / CLARAS study
- Conditions
- Adrenal Disease, Renal Cancer, Surgery--Complications
- Keywords
- laparoscopic surgery, renal surgery, adrenalectomy, complication in laparoscopic surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Collaborators
- Fundacio Puigvert
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 11 Apr 2022 (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 aim of this study is clarify complication and their resolution in laparoscopic renal and adrenal surgery.
Detailed description
the aim of this study is clarify complication and their resolution in laparoscopic renal and adrenal surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complicated patients | – | Procedure: laparoscopic surgery for renal and adrenal diseasespatients underwent to laparoscopic renal and adrenal surgery with intraoperative complications |
| uncomplicated patients | – | –patients underwent to laparoscopic renal and adrenal surgery with no complication during surgical procedure |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients underwent to laparoscopic renal and adrenal surgery form april 2017 to march 2022 in several high volume surgical center
Key inclusion criteria (1 listed)
- renal diseases with indication to surgery adrenal masses
Key exclusion criteria (1 listed)
- open surgery in principle
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 surgery for renal and adrenal diseasestype of treatment for patients underwent to laparoscopic surgery for renal and adrenal diseases with intraoperative complications | Procedure or surgery | complicated patients |
Primary outcome
intraoperative complications
Time frame: 5 years
evaluation of intraoperative complication and their resolution
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Antonino Agrusa, Medicine study director
University of Palermo
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 Disease and Renal Cancer, run by University of Palermo at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Apr 2022. 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 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Di Buono, Medicine (+0916552611, giuseppe.dibuono@unipa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative complications (time frame: 5 years). 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 11 Apr 2022.