UMIN-CTR Clinical Trial

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
Email	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
Email	kendo@jichi.ac.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055254