UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054675 |
|---|---|
| Receipt number | R000062462 |
| Scientific Title | A Study on the Necessity of Discontinuing Antiplatelet and Anticoagulant Therapy Before Hand Surgery A Randomized, Open-Label, Parallel Group Trial |
| Date of disclosure of the study information | 2024/06/17 |
| Last modified on | 2025/06/17 10:11:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Study on the Necessity of Discontinuing Antiplatelet and Anticoagulant Therapy in Patients with Carpal Tunnel Syndrome
Acronym
A Study on the Necessity of Discontinuing Antiplatelet and Anticoagulant Therapy in Patients with Carpal Tunnel Syndrome
Scientific Title
A Study on the Necessity of Discontinuing Antiplatelet and Anticoagulant Therapy Before Hand Surgery A Randomized, Open-Label, Parallel Group Trial
Scientific Title:Acronym
A Study on the Necessity of Discontinuing Antiplatelet and Anticoagulant Therapy Before Hand Surgery A Randomized, Open-Label, Parallel Group Trial
Region
| Japan |
Condition
Condition
Carpal Tunnel Syndrome
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this prospective, randomized, open-label, parallel-group comparative study is to elucidate the impact of discontinuing versus continuing antiplatelet and anticoagulant therapy on postoperative clinical outcomes in patients undergoing endoscopic carpal tunnel release.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient-Rated Functional Assessment Scale:Carpal tunnel syndrome instrument-JSSH
Key secondary outcomes
Complications: Severe bleeding requiring reoperation, wound dehiscence, infection, cardiovascular events
Swelling Assessment: Circumference measurements at the middle finger, hand, and wrist; VAS scores (patient and physician assessment)
Grip Strength and Pinch Strength
Sensory Evaluation: Semmes-Weinstein test
Pain Assessment: VAS scores (patient and physician assessment)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Antithrombotic drugs(Antiplatelet drugs + Anticoagulant drugs) Continuation
Interventions/Control_2
Antithrombotic drugs(Antiplatelet drugs + Anticoagulant drugs) interruption
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for endoscopic carpal tunnel release who are taking antiplatelet or anticoagulant medications, aged 20 years and older
Key exclusion criteria
1 Patients who do not have the capacity to provide informed consent
2 Patients for whom it is not possible to obtain written consent
3 Patients who have not consistently taken antiplatelet or anticoagulant medications
4 Patients deemed unsuitable by the principal investigator or co-investigator, or those whose primary care physician deems it unsafe to discontinue antiplatelet or anticoagulant therapy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tadahiro |
| Middle name | |
| Last name | Natsume |
Organization
Kariya Toyota General Hospital
Division name
Orthopedics
Zip code
448-8505
Address
Aichi, Kariya city, Sumiyoshi cho,5-15
TEL
0566-21-2450
natta197511@gmail.com
Public contact
Name of contact person
| 1st name | Tadahiro |
| Middle name | |
| Last name | Natsume |
Organization
Kariya Toyota General Hospital
Division name
Orthopedics
Zip code
448-8505
Address
Aichi, Kariya city, Sumiyoshi cho,5-15
TEL
0566-21-2450
Homepage URL
natta197511@gmail.com
Sponsor or person
Institute
others
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Kariya Toyota General Hospital
Address
Aichi, Kariya city,Sumiyoshi chou,5-15
Tel
0566-21-2450
natta197511@gmail.com
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
| 2024 | Year | 06 | Month | 17 | 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
65
Results
Results date posted
| 2025 | Year | 06 | Month | 17 | Day |
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
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 16 | Day |
Last modified on
| 2025 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062462
