UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021842 |
|---|---|
| Receipt number | R000025170 |
| Scientific Title | A pilot study of the analgesia after laparoscopic inguinal hernia repair |
| Date of disclosure of the study information | 2016/04/12 |
| Last modified on | 2020/10/11 12:43:43 |
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Basic information
Public title
A pilot study of the analgesia after laparoscopic inguinal hernia repair
Acronym
A pilot study of the analgesia after laparoscopic inguinal hernia repair
Scientific Title
A pilot study of the analgesia after laparoscopic inguinal hernia repair
Scientific Title:Acronym
A pilot study of the analgesia after laparoscopic inguinal hernia repair
Region
| Japan |
Condition
Condition
Inguinal hernia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the analgesia of laparoscopic inguinal hernia to perform day surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative pain score
Key secondary outcomes
Complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TAP block
Interventions/Control_2
Celecoxib(200mg)
Interventions/Control_3
Celecoxib(200mg)+Diclofenac Sodium sup(50mg)
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
Patients who are personally provided written
consent after adequately explained about this study
Key exclusion criteria
Patients who judged as inadequacy due to other reasons by the doctor
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Saito |
Organization
Aichi Medical University
Division name
Gastroenterological Surgery
Zip code
480-1195
Address
1-1, Yazakokarimata, Nagakute-city, Aichi, Japan, 480-1195
TEL
0561-62-3311
tsaito0726@gmail.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Saito |
Organization
Aichi Medical University
Division name
Gastroenterological Surgery
Zip code
480-1195
Address
1-1, Yazakokarimata, Nagakute-city, Aichi, Japan, 480-1195
TEL
0561-62-3311
Homepage URL
tsaito0726@gmail.com
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
no
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
Aichi Medical University
Address
1-1, Yazakokarimata, Nagakute-city, Aichi, Japan, 480-1195
Tel
0561-62-3311
tsaito0726@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
| 2016 | Year | 04 | Month | 12 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 08 | Day |
Last modified on
| 2020 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025170
