UMIN-CTR Clinical Trial

Basic information
Public title	Characteristics of Medical Adverse Events in Laparoscopic/ Thoracoscopic Surgery: A Retrospective study from the Japanese National Database of Medical Adverse Events.
Acronym	Characteristics of Medical Adverse Events in Laparoscopic/ Thoracoscopic Surgery
Scientific Title	Characteristics of Medical Adverse Events in Laparoscopic/ Thoracoscopic Surgery: A Retrospective study from the Japanese National Database of Medical Adverse Events.
Scientific Title:Acronym	Characteristics of Medical Adverse Events in Laparoscopic/ Thoracoscopic Surgery
Region	Japan

Condition
Condition	Medical Adverse Events in Laparoscopic/ Thoracoscopic Surgery from the Japanese National Database of Medical Adverse Events.
Classification by specialty	Surgery in general Obsterics and gynecology Urology Anesthesiology Operative medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify characteristics of medical adverse events in laparoscopic/ thoracoscopic surgery
Basic objectives2	Others
Basic objectives -Others	To clarify characteristics of medical adverse events in laparoscopic/ thoracoscopic surgery
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To clarify the common adverse events. To clarify the reproducible severe events.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Medical adverse events associated with laparoscopic/ thoracoscopic surgery, occurring in operating room, are included in this study. Data are openly available through website of the Japanese National Database of Medical Adverse Events.
Key exclusion criteria	After review of event reports, we exclude the events which are not actually associated with laparoscopic/ thoracoscopic surgery.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takashige Abe
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Urology
Zip code
Address	Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-716-1161
Email	takataka@rf6.so-net.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Sachiyo Murai
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Urology
Zip code
Address	Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-716-1161
Homepage URL
Email	sa0034@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1	015-0008
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 25 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
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	Completed
Date of protocol fixation	2015 Year 03 Month 01 Day
Date of IRB	2015 Year 06 Month 15 Day
Anticipated trial start date	2015 Year 03 Month 31 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To clarify the characteristics of medical adverse events in laparoscopic/ thoracoscopic surgery by using the Japanese national database of medical adverse events.

Management information
Registered date	2015 Year 06 Month 22 Day
Last modified on	2022 Year 07 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020557