UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The risk of preoparative factors influencing postoperative complications and early mobilization undergoing thoracic and abdominal surgery.
Title of the study (Brief title)	The factors influencing of postoperative course undergoing thoracic and abdominal surgery.
Region	Japan

Condition
Condition	Patients undergoing thoracic and abdominal surgery
Classification by specialty	Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is conduct to investigate preoparative factors influencing postoperative complications and early mobilization undergoing thoracic and abdominal surgery.
Basic objectives2	Others
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The factor influencing postoperative mobilization examine preoperative physical function.
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	Inclusion criteria were planned surgery and written informed consent.
Key exclusion criteria	Exclusion criteria were comorbid conditions affecting exercise performance (e.g. musculoskeletal or neurological impairment) and re-operation.
Target sample size	1000

Research contact person
Name of lead principal investigator	Masatoshi Hanada
Organization	Nagasaki University Hospital
Division name	Department of Rehabilitation Medicine
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7258
Email	mstshnd@nagasaki-u.ac.jp

Public contact
Name of contact person	Masatoshi Hanada
Organization	Nagasaki University Hospital
Division name	Department of Rehabilitation Medicine
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7258
Homepage URL
Email	mstshnd@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

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

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

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	長崎大学病院（長崎県），製鉄記念八幡病院(福岡県)，公立陶性病院（愛知県），長崎みなとメディカルセンター市民病院（長崎県），JCHO北海道病院（北海道），聖隷三方原病院（静岡県），KKR高松病院（香川県）

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 01 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study design prospective observational study Inclusion criteria We enrolled in patients underwent cardiac surgery group and thoracic surgery group, abdominal surgery group. Statistical analyses Variables of preoperative physical function, age, gender, body mass index, operative time and blood loss

Management information
Registered date	2016 Year 04 Month 11 Day
Last modified on	2018 Year 02 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025219