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
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
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
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
