Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000627358
Ethics application status
Approved
Date submitted
13/01/2017
Date registered
1/05/2017
Date last updated
1/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Partial nephrectomy in renal cell carcinoma stage pT2: A retrospective outcome analysis and historical comparison.
Scientific title
Partial nephrectomy in renal cell carcinoma stage pT2: A retrospective outcome analysis and historical comparison.
Secondary ID [1] 290907 0
None
Universal Trial Number (UTN)
U1111-1191-5973
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal cell carcinoma stage T2 301624 0
Condition category
Condition code
Cancer 301331 301331 0 0
Kidney
Surgery 301475 301475 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A retrospective review of our prospectively entered nephrectomy registry (Departement of Urology, University of Bern) was performed between 2015-2016. 25 patients were identified who underwent partial nephrectomy for renal cell carcinoma stage pT2 at our institution between 1979 and 2014. Data were analyzed regarding perioperative, oncological and overall outcomes.
Intervention code [1] 296850 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300737 0
Overall survival after partial nephrectomy assessed by review of medical records.
Timepoint [1] 300737 0
After the median follow-up of 21 month.
Secondary outcome [1] 330756 0
Postoperative complication rate by review of medical records and classified according to the Clavien-Dindo classification.
Timepoint [1] 330756 0
Within 30 days after surgery.
Secondary outcome [2] 330757 0
Cancer-specific outcome after partial nephrectomy assesed by review of medical records. Cancer-specific outcome was grouped as cancer-free survival, distant or local recurrence or death from cancer.
Timepoint [2] 330757 0
After the median follow-up of 21 month.
Secondary outcome [3] 332405 0
Comparison between pre- and postoperative renal function by comparing pre- with postoperative serume creatinine. The data was collected through review of medical records.
Timepoint [3] 332405 0
Postoperative renal function was assessed before discharge from the hospital.
Secondary outcome [4] 332406 0
Tumor characteristics.
Timepoint [4] 332406 0
According to the histopathological report.

Eligibility
Key inclusion criteria
Patients with renal cell carcinoma stage pT2 that underwent a partial nephrectomy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
All patients that underwent partial nephrectomy and met the inclusion criteria were included.
The SPSS software package version 23.0. (IBM Corp., Somers, NY, USA) was used for all statistical analyses. Comparisons between pre- and postoperative renal function groups were performed using Paired T-test. Overall and cancer-specific survival were estimated using the Kaplan-Meier method.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
Actual
30/06/2016
Date of last data collection
Anticipated
Actual
29/07/2016
Sample size
Target
50
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 8571 0
Switzerland
State/province [1] 8571 0
Bern

Funding & Sponsors
Funding source category [1] 295329 0
University
Name [1] 295329 0
University of Bern, Department of Urology
Country [1] 295329 0
Switzerland
Primary sponsor type
University
Name
Urologische Universitaetsklinik, Inselspital Bern
Address
Urologische Universitaetsklinik, Inselspital
Anna Seiler-Haus
Freiburgstrasse 5
3010 Bern
Country
Switzerland
Secondary sponsor category [1] 294152 0
None
Name [1] 294152 0
Address [1] 294152 0
Country [1] 294152 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296665 0
Swissethics - Ethikkommission fuer Forschung am Menschen
Ethics committee address [1] 296665 0
Ethics committee country [1] 296665 0
Switzerland
Date submitted for ethics approval [1] 296665 0
04/10/2016
Approval date [1] 296665 0
12/12/2016
Ethics approval number [1] 296665 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71686 0
Prof Prof Dr. med. George Niklaus Thalmann
Address 71686 0
Universitaetsklinik fuer Urologie
Anna Seiler Haus
3010 Bern
Country 71686 0
Switzerland
Phone 71686 0
+41 31 362 21 11
Fax 71686 0
Email 71686 0
george.thalmann@insel.ch
Contact person for public queries
Name 71687 0
Prof Dr. med. George Niklaus Thalmann
Address 71687 0
Universitaetsklinik fuer Urologie
Anna Seiler Haus
3010 Bern
Country 71687 0
Switzerland
Phone 71687 0
+41 31 362 21 11
Fax 71687 0
Email 71687 0
george.thalmann@insel.ch
Contact person for scientific queries
Name 71688 0
Prof Dr. med. George Niklaus Thalmann
Address 71688 0
Universitaetsklinik fuer Urologie
Anna Seiler Haus
3010 Bern
Country 71688 0
Switzerland
Phone 71688 0
+41 31 362 21 11
Fax 71688 0
Email 71688 0
george.thalmann@insel.ch

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.