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Complication in Laparoscopic Renal and Adrenal Surgery (CLARAS) (CLARAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05322265
Recruitment Status : Recruiting
First Posted : April 11, 2022
Last Update Posted : April 11, 2022
Sponsor:
Collaborator:
Fundacio Puigvert
Information provided by (Responsible Party):
Prof. Antonino Agrusa, University of Palermo

Study Description
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Brief Summary:
the aim of this study is clarify complication and their resolution in laparoscopic renal and adrenal surgery.

Condition or disease Intervention/treatment
Adrenal Disease Renal Cancer Surgery--Complications Procedure: laparoscopic surgery for renal and adrenal diseases

Detailed Description:
the aim of this study is clarify complication and their resolution in laparoscopic renal and adrenal surgery.
Study Design
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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Complication in Laparoscopic Renal and Adrenal Surgery (CLARAS): an International Multicenter Study
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : March 31, 2022
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
complicated patients
patients underwent to laparoscopic renal and adrenal surgery with intraoperative complications
 Procedure: laparoscopic surgery for renal and adrenal diseases
type of treatment for patients underwent to laparoscopic surgery for renal and adrenal diseases with intraoperative complications
uncomplicated patients
patients underwent to laparoscopic renal and adrenal surgery with no complication during surgical procedure


Outcome Measures
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Primary Outcome Measures :
  1. intraoperative complications [ Time Frame: 5 years ]
    evaluation of intraoperative complication and their resolution


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients underwent to laparoscopic renal and adrenal surgery form april 2017 to march 2022 in several high volume surgical center
Criteria

Inclusion Criteria:

renal diseases with indication to surgery adrenal masses

Exclusion Criteria:

open surgery in principle

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05322265


Contacts
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Contact: Giuseppe Di Buono, Medicine +0916552611 giuseppe.dibuono@unipa.it
Contact: Antonino Agrusa, Medicine +390916552612 antonino.agrusa@unipa.it

Locations
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Italy
University of Palermo Recruiting
Palermo, Italy, 90127
Contact: Giuseppe Di Buono, Medicine    +390916552611    giuseppe.dibuono@unipa.it   
Contact: Antonino Agrusa, Medicine    +390916552612    antonino.agrusa@unipa.it   
Sponsors and Collaborators
University of Palermo
Fundacio Puigvert
Investigators
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Study Director: Antonino Agrusa, Medicine University of Palermo
More Information
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Responsible Party: Prof. Antonino Agrusa, full professor of surgery, University of Palermo
ClinicalTrials.gov Identifier: NCT05322265    
Other Study ID Numbers: CLARAS study
First Posted: April 11, 2022    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Antonino Agrusa, University of Palermo:
laparoscopic surgery
renal surgery
adrenalectomy
complication in laparoscopic surgery
Additional relevant MeSH terms:
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Kidney Neoplasms
Adrenal Gland Diseases
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Endocrine System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents