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Sponsor study identifier
observational
300
1 country
1
Study Start
June 1, 2019
Actual (reported)Primary Completion
September 30, 2022
Actual (reported)Study Completion
September 30, 2022
Actual (reported)STUDY DESIGN: prospective multicentric observational SAMPLE SIZE OF THE STUDY: The estimated number of patients to enroll in the multicenter study is at least 270 patients (statistically calculated referring to the results of a monocentric analysis including 101 patients with the same design, already performed by the Coordinator Center). NUMBER OF CENTERS INVOLVED: Considering a total number of patients enrolled of at least 270, number of Centers to be involved: 5. STUDY PROCEDURES: 3D virtual model rendering
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2022
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2019
Actual (reported)September 30, 2022
Actual (reported)September 30, 2022
Actual (reported)January 23, 2023
Actual (reported)February 15, 2023
Actual (reported)PADUA nephrometry score calculated via 3D virtual modelling and standard bidimensional CT scan images
The PADUA nephrometry score predicts the risk of surgical and medical perioperative complications in patients who underwent partial nephrectomy. The PADUA nephrometry score evaluates different tumor characteristics: * Longitudinal (polar) location (Superior/inferior: 1pt; Middle: 2 pt), * Exophytic rate (\>=50%: 1pt; \<50%: 2pt; Endophytic: 3pt) * Renal rim (Lateral: 1pt; Medial: 2pt) * Renal sinus (Not involved: 1pt; Involved: 2pt) * Urinary collecting system (Not involved: 1pt; Dislocated/infiltrated: 2pt) * Tumor size (\<=4 cm: 1pt; 4.1-7 cm: 2pt; \>7: 3pt) The PADUA score, calculated as the sum of these parameters, stratify patients from PADUA 6 tumors, that have low risk of complications, to PADUA 14, with high risk of perioperative complications.
Baseline
To compare the occurrence of postoperative complications, assessed by Clavien-Dindo classification
90 days after surgery
Patients with localized renal tumor scheduled for minimally invasive partial nephrectomy in which 2D- and 3D-PADUA nephrometric score assessment was performed preoperatively
Evaluation of the PADUA nephrometric score with 3D images
Evaluation of the PADUA nephrometric score with 2D images
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with localized renal tumor scheduled for partial nephrectomy
San Luigi Gonzaga Hospital
Orbassano, TO, 10048, Italy
300 participants (actual enrollment reported by the registry).
First Submitted
January 23, 2023
First Posted
February 15, 2023
Study Start
June 1, 2019
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
September 30, 2022
Actual (reported)Study Completion
September 30, 2022
Actual (reported)Last Updated
February 15, 2023
Record last verified: 2023-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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