UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050838 |
|---|---|
| Receipt number | R000057938 |
| Scientific Title | Manual reduction of strangulated internal hemorrhoids using sugar |
| Date of disclosure of the study information | 2023/04/13 |
| Last modified on | 2024/06/10 12:11:30 |
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Basic information
Public title
Manual reduction of strangulated internal hemorrhoids using sugar
Acronym
Manual reduction of strangulated internal hemorrhoids using sugar
Scientific Title
Manual reduction of strangulated internal hemorrhoids using sugar
Scientific Title:Acronym
Manual reduction of strangulated internal hemorrhoids using sugar
Region
| Japan |
Condition
Condition
strangulated internal hemorrhoids
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Report on manual reduction of strangulated internal hemorrhoids using sugar
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
manual reduction of strangulated internal hemorrhoids
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 51 | years-old | <= |
Age-upper limit
| 51 | years-old | > |
Gender
Female
Key inclusion criteria
Patient with strangulated internal hemorrhoids
Key exclusion criteria
none
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Goshi |
| Middle name | |
| Last name | Fujimoto |
Organization
Koga Community Hospital
Division name
Department of Gastroenterological Surgery
Zip code
425-0088
Address
2-30-1 Daikakuji, Yaizu, Shizuoka 425-0088, Japan
TEL
0546285500
goshi-fujimoto@ymail.ne.jp
Public contact
Name of contact person
| 1st name | Goshi |
| Middle name | |
| Last name | Fujimoto |
Organization
Koga Community Hospital
Division name
Gastroenterological surgery
Zip code
425-0088
Address
2-30-1 Daikakuji, Yaizu, Shizuoka 425-0088, Japan
TEL
0546285500
Homepage URL
goshi-fujimoto@ymail.ne.jp
Sponsor or person
Institute
Koga Community Hospita
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Koga Community Hospital
Address
2-30-1 Daikakuji, Yaizu, Shizuoka 425-0088, Japan
Tel
0546285500
goshi-fujimoto@ymail.ne.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 13 | Day |
Related information
URL releasing protocol
https://www.cureus.com/articles/234941-manual-reduction-of-strangulated-internal-hemorrhoids-using-s
Publication of results
Published
Result
URL related to results and publications
https://www.cureus.com/articles/234941-manual-reduction-of-strangulated-internal-hemorrhoids-using-s
Number of participants that the trial has enrolled
1
Results
We applied sugar directly to the prolapsed internal hemorrhoids. Ten minutes later, the number of prolapsed hemorrhoids decreased, and manual reduction was possible.
Results date posted
| 2024 | Year | 06 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A 51-year-old female patient presented prolapsed internal hemorrhoids.
Participant flow
Due to significant pain and difficulty during the manual reduction of the hemorrhoids, the patient was transported to the emergency room.
Adverse events
none
Outcome measures
Manual reduction of prolapsed internal hemorrhoids
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 04 | Month | 13 | Day |
Last modified on
| 2024 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057938
