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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041002
Receipt No. R000046820
Scientific Title An observational cohort study to clarify the prevalence and severity of chronic postsurgical pain after mitral valve repair
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/04

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Basic information
Public title An observational cohort study to clarify the prevalence and severity of chronic postsurgical pain after mitral valve repair
Acronym PAIN-MVP
Scientific Title An observational cohort study to clarify the prevalence and severity of chronic postsurgical pain after mitral valve repair
Scientific Title:Acronym PAIN-MVP
Region
Japan

Condition
Condition patients who underwent mitral valve repair in conjunction with other cardiac surgery
Classification by specialty
Surgery in general Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We hypothesized that the prevalence and severity of CPSP is higher among patients after mitral valve repair via thoracotomy versus sternotomy. To test this hypothesis, we conducted a prospective cohort study
Basic objectives2 Others
Basic objectives -Others We hypothesized that the prevalence and severity of CPSP is higher among patients after mitral valve repair via thoracotomy versus sternotomy. To test this hypothesis, we conducted a prospective cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The main outcomes were the severity of CPSP evaluated using NRS and the prevalence of CPSP. CPSP was defined as pain > 0 that developed after a surgical procedure and persisted for at least 3 months after surgery. Between-group differences in severity were compared
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients who underwent mitral valve repair after January 2014.
Key exclusion criteria none
Target sample size 450

Research contact person
Name of lead principal investigator
1st name Kimito
Middle name
Last name Minami
Organization National Cerebral and Cardiovascular Center
Division name Department of Surgical Intensive Care
Zip code 564-8565
Address 6-1 Kishibeshinmachi, Suita, Osaka
TEL 06-6170-1070
Email k.minami@ncvc.go.jp

Public contact
Name of contact person
1st name Kimito
Middle name
Last name Minami
Organization National Cerebral and Cardiovascular Center
Division name Department of surgical intensive care
Zip code 564-8565
Address 6-1 Kishibeshinmachi, Suita, Osaka
TEL 06-6170-1070
Homepage URL
Email k.minami@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization National Cerebral and Cardiovascular Center
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 National Cerebral and Cardiovascular Center
Address 6-1 Kishibeshinmachi, Suita, Osaka
Tel 06-6170-1070
Email k.minami@ncvc.go.jp

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
2020 Year 08 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 Enrolling by invitation
Date of protocol fixation
2020 Year 07 Month 01 Day
Date of IRB
2020 Year 07 Month 01 Day
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2021 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This observational cohort study included surviving patients who underwent mitral valve repair via thoracotomy or sternotomy. A questionnaire about the severity of surgical wound pain evaluated with a numerical rating scale (NRS) was sent to patients who underwent mitral valve repair via sternotomy or thoracotomy. NRS responses for current pain, peak pain in the last 4 weeks, and average pain in the last 4 weeks were evaluated. The main outcomes were the severity of CPSP evaluated using NRS and the prevalence of CPSP. CPSP was defined as pain > 0 that developed after a surgical procedure and persisted for at least 3 months after surgery. Between-group differences in severity were compared using multivariable ordinal logistic regression. Between-group differences in prevalence were compared using multivariable logistic regression.

Management information
Registered date
2020 Year 07 Month 04 Day
Last modified on
2020 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046820

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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