UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027012
Receipt number R000030972
Scientific Title Incidence of chronic post surgical pain, associated factors and burden in quality of life.
Date of disclosure of the study information 2017/04/29
Last modified on 2017/04/17 03:28:47

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Basic information

Public title

Incidence of chronic post surgical pain, associated factors and burden in quality of life.

Acronym

Incidence of chronic post surgical pain, associated factors and burden in quality of life.

Scientific Title

Incidence of chronic post surgical pain, associated factors and burden in quality of life.

Scientific Title:Acronym

Incidence of chronic post surgical pain, associated factors and burden in quality of life.

Region

South America


Condition

Condition

CHRONIC POSTOPERATIVE PAIN

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Calculate the incidence of chronic post surgical pain in patients with major surgical procedures in the University Hospital Fundacion Santa Fe de Bogota with the aim of understanding the epidemiologic behavior of this pain syndrome, and identifying risk and protective factors.

Basic objectives2

Others

Basic objectives -Others

Measure changes in quality of life originated by chronic postsurgical pain in patients with major surgery using the life quality questionnaire SF-36. "

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Prevalence in chronic postsurgical pain

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

Patients in the hospital university Fundacion Santa Fe de Bogota, over 18 years old, taken to elective surgery knee hip and shoulder arthroplasty, mastectomy, thoracothomy, cesarean
etc who have accepted and signed the informed consent

Key exclusion criteria

Patients with cognitive impairment who cannot answer the questionnaire correctly or patients who do not want to take part of the study

Target sample size

208


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jairo R Moyano

Organization

Hospital University Fundacion Santa Fe de Bogota

Division name

Pain Clinic

Zip code


Address

Calle 119#7-75

TEL

5716030303

Email

jmoyano@unbosque.edu.co


Public contact

Name of contact person

1st name
Middle name
Last name Jairo R Moyano

Organization

Hospital University Fundacion Santa Fe de Bogota

Division name

Pain Clinic

Zip code


Address

Calle 119#7-75

TEL

5716030303

Homepage URL


Email

jmoyano@unbosque.edu.co


Sponsor or person

Institute

Hospital University Fundacion Santa Fe de Bogota

Institute

Department

Personal name



Funding Source

Organization

Self funding

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


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



Other administrative information

Date of disclosure of the study information

2017 Year 04 Month 29 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

Terminated

Date of protocol fixation

2014 Year 06 Month 10 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 19 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

patients with major surgical procedures were followed over a period of three months in which pain socres and quality of life were evaluated.


Management information

Registered date

2017 Year 04 Month 17 Day

Last modified on

2017 Year 04 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030972


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name