UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052054 |
|---|---|
| Receipt number | R000059416 |
| Scientific Title | An exploratory prospective observational study on the effects of gut microbiota and diet on acute postoperative pain. |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2025/03/13 17:37:30 |
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Basic information
Public title
An exploratory prospective observational study on the effects of gut microbiota and diet on acute postoperative pain.
Acronym
An exploratory prospective observational study on the effects of gut microbiota and diet on acute postoperative pain.
Scientific Title
An exploratory prospective observational study on the effects of gut microbiota and diet on acute postoperative pain.
Scientific Title:Acronym
An exploratory prospective observational study on the effects of gut microbiota and diet on acute postoperative pain.
Region
| Japan |
Condition
Condition
shoulder rotator cuff tear
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between diet and postoperative acute pain as a background factor for gut microbiota by means of a questionnaire.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum pain score (NRS) at 24 hours postoperatively
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All adult patients aged 18 years and over undergoing specoscopic shoulder joint surgery under general anaesthesia at Chiba University Hospital
Key exclusion criteria
under 18 years of age
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Natsuko |
| Middle name | |
| Last name | Taguchi |
Organization
Chiba University Hospital
Division name
Department of Anesthesiology
Zip code
260-8677
Address
1-8-1 Inohana Chuo Chiba JAPAN
TEL
+81-43-226-2303
nn_taguchi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | KOTONO |
| Middle name | |
| Last name | YAMADA |
Organization
Chiba University Hospital
Division name
Department of Anesthesiology
Zip code
260-8677
Address
1-8-1 Inohana Chuo Chiba JAPAN
TEL
+81-43-226-2303
Homepage URL
kotono1004@yahoo.co.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba University Hospital
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
Chiba University Hospital
Address
1-8-1 Inohana Chuo Chiba JAPAN
Tel
+81-43-226-2303
masui@office.chiba-u.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
HK202305-16
Org. issuing International ID_1
Chiba University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | 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
Terminated
Date of protocol fixation
| 2023 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A preoperative questionnaire (Food Frequency Questionnaire) is used to determine the frequency and intake of dietary fibre, which is said to be closely related to the gut microbiota. In addition to age, body mass index (BMI), preoperative pain score (Numerical Rating Scale) and anxiety score (GAD-7), the diversity of the intestinal microbiota (alpha diversity) and defecation status (Bristol Stool Scale) as risk factors for increased postoperative pain Multivariate analysis of the association of the postoperative NRS with 12 items: dietary fibre intake, opioids, antidepressants, acetaminophen, NSAIDs and analgesic aids as oral medications.
Management information
Registered date
| 2023 | Year | 08 | Month | 30 | Day |
Last modified on
| 2025 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059416
