UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026532 |
|---|---|
| Receipt number | R000030466 |
| Scientific Title | A Randomized Trial of Transanal Hemorrhoidal Dearterialization With Mucopexy Compared With Hemorrhoidectomy Using an Ultrasonic Scalpel for Grade III hemorrhoids |
| Date of disclosure of the study information | 2017/03/14 |
| Last modified on | 2023/09/20 16:25:49 |
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Basic information
Public title
A Randomized Trial of Transanal Hemorrhoidal Dearterialization With Mucopexy Compared With Hemorrhoidectomy Using an Ultrasonic Scalpel for Grade III hemorrhoids
Acronym
Randomized Trial of THD with hemorrhoidectomy
Scientific Title
A Randomized Trial of Transanal Hemorrhoidal Dearterialization With Mucopexy Compared With Hemorrhoidectomy Using an Ultrasonic Scalpel for Grade III hemorrhoids
Scientific Title:Acronym
Randomized Trial of THD with hemorrhoidectomy
Region
| Japan |
Condition
Condition
Third degree internal hemorrhoids
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study was to compare early and midterm results of transanal Doppler-guided hemorrhoidal dearterialization with mucopexy (DM) versus hemorrhoidectomy using an ultrasonic scalpel (US) for third degree hemorrhoids.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative pain scores
Key secondary outcomes
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
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
operation:one day
Interventions/Control_2
pain score: 2 weeks
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with symptomatic grade III hemorrhoids
Key exclusion criteria
thrombosed hemorrhoids, anal fissure, anal fistulas, anal polyps
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Tsunoda |
Organization
Kameda Medical Center
Division name
Department of Gastroenterological Surgery
Zip code
296-8602
Address
929 Higashicho, Kamogawa-City, Chiba
TEL
04-7092-2211
tsunoda.akira@kameda.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Tsunoda |
Organization
Kameda Medical Center
Division name
Department of Gastroenterological Surgery
Zip code
296-8602
Address
929 Higashicho, Kamogawa-City, Chiba
TEL
04-7092-2211
Homepage URL
tsunoda.akira@kameda.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kameda Medical Center Research Foundation
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
Ethical Committee of Kameda Medical Center
Address
929 Higashicho, Kamogawa City, Chiba
Tel
04-7092-2211
clinical_research@kameda.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
| 2017 | Year | 03 | Month | 14 | 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
| 2013 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 13 | Day |
Last modified on
| 2023 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030466
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/09/16 | 実施計画書.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/09/16 | ケースカード .xls |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/09/16 | 2017-05-30 完全解析用(n=44) RCT comparing THD with HS.sav |
Single case data URL
Value
https://center6.umin.ac.jp/ice/30466
