UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048486 |
|---|---|
| Receipt number | R000055254 |
| Scientific Title | analysis of operative outcomes of lateral retroperitoneal adrenalectomy in a teaching hospital |
| Date of disclosure of the study information | 2022/08/31 |
| Last modified on | 2022/07/27 14:00:43 |
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Basic information
Public title
analysis of operative outcomes of lateral retroperitoneal adrenalectomy in a teaching hospital
Acronym
analysis of operative outcomes of lateral retroperitoneal adrenalectomy in a teaching hospital
Scientific Title
analysis of operative outcomes of lateral retroperitoneal adrenalectomy in a teaching hospital
Scientific Title:Acronym
analysis of operative outcomes of lateral retroperitoneal adrenalectomy in a teaching hospital
Region
| Japan |
Condition
Condition
adrenal disease
Classification by specialty
| Surgery in general | Endocrine surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
analysis of operative outcomes in the introduction period and the educational period
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
operative time, estimate blood loss, complication
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients underwent LRPA for a variety of benign and malignant diseases between January 2006 and December 2020.
Key exclusion criteria
Patients with severe systemic illnesses who do not tolerate surgery in the lateral recumbent position and patients who did not want to undergo LRPA were excluded.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | ENDO |
Organization
Jichi Medical University
Division name
Department of Surgery
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL
0285587371
kendo@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | ENDO |
Organization
Jichi Medical University
Division name
Department of Surgery
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL
0285587371
Homepage URL
kendo@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Institutional Review Board of Jichi Medical University
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
Tel
0285442111
kendo@jichi.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
自治医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
179
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2006 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observational study
Management information
Registered date
| 2022 | Year | 07 | Month | 27 | Day |
Last modified on
| 2022 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055254
