UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015362 |
|---|---|
| Receipt number | R000017876 |
| Scientific Title | The prospective study of the effect of periodic oral NSAIDs for wound pain after hepatectomy |
| Date of disclosure of the study information | 2014/10/07 |
| Last modified on | 2017/04/09 11:08:46 |
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Basic information
Public title
The prospective study of the effect of periodic oral NSAIDs for wound pain after hepatectomy
Acronym
The prospective study of the effect of periodic oral NSAIDs for wound pain after hepatectomy
Scientific Title
The prospective study of the effect of periodic oral NSAIDs for wound pain after hepatectomy
Scientific Title:Acronym
The prospective study of the effect of periodic oral NSAIDs for wound pain after hepatectomy
Region
| Japan |
Condition
Condition
Patients of open or laparoscopic hepatectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is evaluating the early postoperative degree of the wonud pain and quantity of exercise by administering periodic NSAIDs for wound pain after hepatectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. The subjective assessment of the degree of the postoperative wound pain according to VAS (Visual Analog Scale)
2. The objective assessment of the degree of the postoperative wound pain according to PainVision (Measurement device of the quantity of pain)
3. The assessment of the property of postoperative wound pain according to SF-MPQ(Short-Form McGill pain questionnaire)
4. The assessment of the quantity of exercise according to Calorie Counter (pedometer)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Open hepatectomy: Patients are administered 1 tablets of loxoprofen, 3 times a day and 1 tablets of H2 blocker, twice a day from 1 to 10 postoperative days.
Laparoscopic hepatectomy: Patients are administered 1 tablets of loxoprofen, twice a day and 1 tablets of H2 blocker, twice a day from 1 to 10 postoperative days.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria:
1. Patients who agree with written informed consent for the present study
2. Patients who can press a hand switch by sensing the stimulation current
Key exclusion criteria
Exclusion criteria:
1. Patients with impaired skin in the forearm ulnar portion
2. Patients with history of duodenal or stomach ulcer
3. Patients with renal dysfunction (Creatinin 2mg/dl or more)
4. Patients with using electronic implants or other cardiac pacemaker
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroya Iida |
Organization
Kansai Medical University
Division name
Surgery
Zip code
Address
2-3-1 Shin-machi Hirakata Osaka
TEL
072-804-0101
iidahiro@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroya Iida |
Organization
Kansai Medical University
Division name
Surgery
Zip code
Address
2-3-1 Shin-machi Hirakata Osaka
TEL
072-804-0101
Homepage URL
iidahiro@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical Univresity
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Address
Tel
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
| 2014 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We demonstrated the usefulness of NSAIDs for pain after hepatectomy.
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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 07 | Day |
Last modified on
| 2017 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017876
