UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048615 |
|---|---|
| Receipt number | R000055332 |
| Scientific Title | A single-center prospective cohort study in the association between digit ratio and postoperative nausea and vomiting |
| Date of disclosure of the study information | 2022/08/08 |
| Last modified on | 2024/03/05 23:08:03 |
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Basic information
Public title
Relationship between digit ratio and postoperative nausea and vomiting
Acronym
Relationship between digit ratio and postoperative nausea and vomiting
Scientific Title
A single-center prospective cohort study in the association between digit ratio and postoperative nausea and vomiting
Scientific Title:Acronym
A single-center prospective cohort study in the association between digit ratio and postoperative nausea and vomiting
Region
| Japan |
Condition
Condition
postoperative nausea and vomiting
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the relationship between digit ratio and postoperative nausea and vomiting.
Basic objectives2
Others
Basic objectives -Others
To evaluate whether the digit ratio is a risk for postoperative nausea and vomiting to determine if more aggressive PONV prophylaxis is needed.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Digit ratio and incidence of postoperative nausea and vomiting
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 undergoing general anesthesia for elective surgery
Key exclusion criteria
Emergency surgery, anesthesia less than 90 minutes, dementia, patients scheduled to be discharged within 24 hours or difficult to evaluate after 24 hours, patients under 18 years of age, and patients with difficulty measuring finger length.
Target sample size
882
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Chiba |
Organization
Jichi Medical University Saitama Medical Center
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
330-0834
Address
1-847, Amanuma, Omiya, Saitama, Saitama, 330-8503, Japan
TEL
048-647-2111
yoshihiko.chiba92@gmail.com
Public contact
Name of contact person
| 1st name | Ifumi |
| Middle name | |
| Last name | Takeuchi |
Organization
Jichi Medical University Saitama Medical Center
Division name
Department of Clinical Trial Promotion
Zip code
330-0834
Address
1-847, Amanuma, Omiya, Saitama, Saitama, 330-8503, Japan
TEL
048-647-2111
Homepage URL
s-suishin@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University Saitama Medical Center
Address
1-847, Amanuma, Omiya, Saitama, Saitama, 330-8503, Japan
Tel
048-647-2111
s-suishin@jichi.ac.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
自治医科大学附属さいたま医療センター(埼玉県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 08 | 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
870
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A single-center prospective cohort study.
Participants in the study are patients undergoing scheduled surgery at Jichi Medical University Saitama Medical Center.
Management information
Registered date
| 2022 | Year | 08 | Month | 07 | Day |
Last modified on
| 2024 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055332
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
