UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039604 |
|---|---|
| Receipt number | R000045165 |
| Scientific Title | Evaluation of hemorrhoidectomy for elderly patients |
| Date of disclosure of the study information | 2020/02/26 |
| Last modified on | 2020/02/26 11:16:44 |
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Basic information
Public title
Evaluation of hemorrhoidectomy for elderly patients
Acronym
Evaluation of hemorrhoidectomy for elderly patients
Scientific Title
Evaluation of hemorrhoidectomy for elderly patients
Scientific Title:Acronym
Evaluation of hemorrhoidectomy for elderly patients
Region
| Japan |
Condition
Condition
Hemorrhoids
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate short-term outcomes in surgical indications for elderly patients with hemorrhoids and to clarify the risk factors for complications and recurrence, thereby assisting medical treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative complications
Key secondary outcomes
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| 91 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing hemorrhoidectomy for hemorrhoids with a Goligher classification of Grade 3 and 4 at our hospital between January 2014 and December 2018
Key exclusion criteria
Patients with previous hemorrhoid surgeries, intestinal bowel disease or colorectal carcinoma
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masateru |
| Middle name | |
| Last name | Yamamoto |
Organization
National Hospital Organization Yanai Medical Center
Division name
Department of Surgery
Zip code
742-1352
Address
95 Ihonosho, Yanai, Yamaguchi
TEL
0820-27-0211
mayamamoto@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Masateru |
| Middle name | |
| Last name | Yamamoto |
Organization
National Hospital Organization Yanai Medical Center
Division name
Department of Surgery
Zip code
742-1352
Address
95 Ihonosho, Yanai, Yamaguchi
TEL
0820-27-0211
Homepage URL
mayamamoto@hiroshima-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Yanai Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Yanai Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Yanai Medical Center
Address
95 Ihonosho, Yanai, Yamaguchi
Tel
0820-27-0211
514-kanri@mail.hosp.go.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
| 2020 | Year | 02 | Month | 26 | 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
100
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
| 2019 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The baseline clinicopathological findings were retrieved and reviewed from the hospital database.
Management information
Registered date
| 2020 | Year | 02 | Month | 26 | Day |
Last modified on
| 2020 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045165
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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