UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective single-center study for identifying risk factors of postoperative complications in general and digestive surgery
Acronym	Retrospective single-center study for identifying risk factors of postoperative complications in general and digestive surgery
Scientific Title	Retrospective single-center study for identifying risk factors of postoperative complications in general and digestive surgery
Scientific Title:Acronym	Retrospective single-center study for identifying risk factors of postoperative complications in general and digestive surgery
Region	Japan

Condition
Condition	Patients underwent digestive and general surgery
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To identify risk factors for postoperative complications
Basic objectives2	Others
Basic objectives -Others	To examine the impact of postoperative ambulation on short-term outcome
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Presence/Absence of Postoperative complications
Key secondary outcomes	Hospitalization Discharge destination

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent major digestive surgery (surgical procedures with resection of the gastrointestinal tract, liver, biliary tract, or pancreas)
Key exclusion criteria	1) patients were under 19 years old 2) patients underwent emergency surgery
Target sample size	1300

Research contact person
Name of lead principal investigator	1st name Tsutomu Middle name Last name Fujii
Organization	Faculty of Medicine, Academic Assembly University of Toyama
Division name	Department of Surgery and Science
Zip code	930-0194
Address	2630, Sugitani, Toyama
TEL	+81-76-434-7331
Email	fjt@med.u-toyama.ac.jp

Public contact
Name of contact person	1st name Hayato Middle name Last name Baba
Organization	Faculty of Medicine, Academic Assembly University of Toyama
Division name	Department of Surgery and Science
Zip code	930-0194
Address	2630, Sugitani, Toyama
TEL	+81-76-434-7331
Homepage URL
Email	h881088@med.u-toyama.ac.jp

Sponsor
Institute	University of Toyama
Institute
Department

Funding Source
Organization	University of Toyama
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics Committee, University of Toyama
Address	2630, Sugitani, Toyama
Tel	+81-76-415-8857
Email	rinri@adm.u-toyama.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

Other administrative information
Date of disclosure of the study information	2020 Year 05 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
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	Suspended
Date of protocol fixation	2016 Year 01 Month 01 Day
Date of IRB	2020 Year 04 Month 30 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A retrospective study

Management information
Registered date	2020 Year 04 Month 03 Day
Last modified on	2020 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045657