UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Incidence of chronic post surgical pain, associated factors and burden in quality of life.
Title of the study (Brief title)	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	Jairo R Moyano
Organization	Hospital University Fundacion Santa Fe de Bogota
Division name	Pain Clinic
Address	Calle 119#7-75
TEL	5716030303
Email	jmoyano@unbosque.edu.co

Public contact
Name of contact person	Jairo R Moyano
Organization	Hospital University Fundacion Santa Fe de Bogota
Division name	Pain Clinic
Address	Calle 119#7-75
TEL	5716030303
Homepage URL
Email	jmoyano@unbosque.edu.co

Sponsor
Institute	Hospital University Fundacion Santa Fe de Bogota
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 06 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030972