UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021875
Receipt number R000025219
Scientific Title The risk of preoparative factors influencing postoperative complications and early mobilization undergoing thoracic and abdominal surgery.
Date of disclosure of the study information 2016/05/01
Last modified on 2018/02/11 09:44:36

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Basic information

Public title

The risk of preoparative factors influencing postoperative complications and early mobilization undergoing thoracic and abdominal surgery.

Acronym

The factors influencing of postoperative course undergoing thoracic and abdominal surgery.

Scientific Title

The risk of preoparative factors influencing postoperative complications and early mobilization undergoing thoracic and abdominal surgery.

Scientific Title:Acronym

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

1st name
Middle name
Last name Masatoshi Hanada

Organization

Nagasaki University Hospital

Division name

Department of Rehabilitation Medicine

Zip code


Address

1-7-1 Sakamoto, Nagasaki

TEL

095-819-7258

Email

mstshnd@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masatoshi Hanada

Organization

Nagasaki University Hospital

Division name

Department of Rehabilitation Medicine

Zip code


Address

1-7-1 Sakamoto, Nagasaki

TEL

095-819-7258

Homepage URL


Email

mstshnd@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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 12 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025219


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name