UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024128 |
|---|---|
| Receipt number | R000027782 |
| Scientific Title | The Effect of Quinine Hydrochloride on Pain after Hemorrhoidectomy |
| Date of disclosure of the study information | 2016/09/22 |
| Last modified on | 2016/09/29 11:04:12 |
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Basic information
Public title
The Effect of Quinine Hydrochloride on Pain after Hemorrhoidectomy
Acronym
The Effect of Quinine Hydrochloride on Pain after Hemorrhoidectomy
Scientific Title
The Effect of Quinine Hydrochloride on Pain after Hemorrhoidectomy
Scientific Title:Acronym
The Effect of Quinine Hydrochloride on Pain after Hemorrhoidectomy
Region
| Japan |
Condition
Condition
Hemorrhoids(Goligher 3rd or 4th degree)
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have evaluated the effects of topical quinine hydrochloride
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The postoperative pain scores (until 7 days after surgery)
Key secondary outcomes
1) Post operative adverse effects
2) Patients satisfaction postoperatively
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Subcutaneous injection of 2% quinine hydrochloride for wound immediately after surgery(4ml/body).
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who had Goligher 3rd or 4th degree hemorrhoids
Key exclusion criteria
1) patients with anticoagulant therapy
2) Pregnancy, nursing women
3) Attending doctors judgement
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shirahata Atsushi |
Organization
Yokohama Asahi Chuo General Hospital
Division name
Gastrointestinal Surgery
Zip code
Address
4-20-1, Wakabadai, Asahi-ku, Yokohama-city, Kanagawa
TEL
045-921-6111
shirahataa@asahi-hp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shirahata Atsushi |
Organization
Yokohama Asahi Chuo General Hospital
Division name
Gastrointestinal Surgery
Zip code
Address
4-20-1, Wakabadai, Asahi-ku, Yokohama-city, Kanagawa
TEL
045-921-6111
Homepage URL
shirahataa@asahi-hp.jp
Sponsor or person
Institute
Yokohama Asahi Chuo General Hospital Gastrointestinal Surgery
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
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
| 2016 | Year | 09 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 05 | 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
| 2016 | Year | 09 | Month | 22 | Day |
Last modified on
| 2016 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027782
