UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039654 |
|---|---|
| Receipt number | R000045228 |
| Scientific Title | A study on the usefulness of robot-assisted radical inguinal hernia repair |
| Date of disclosure of the study information | 2020/03/10 |
| Last modified on | 2023/03/03 14:25:07 |
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Basic information
Public title
A study on the usefulness of robot-assisted radical inguinal hernia repair
Acronym
A study on the usefulness of robot-assisted radical inguinal hernia repair
Scientific Title
A study on the usefulness of robot-assisted radical inguinal hernia repair
Scientific Title:Acronym
A study on the usefulness of robot-assisted radical 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
To explore the indices related to the effectiveness of robot-assisted inguinal hernia repair for inguinal hernia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
conversion rate to other approaches
Key secondary outcomes
Bleeding volume
Transfusion volume
Total surgery time
Console time
Intraoperative adverse events
Postoperative adverse events
recurrence
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Robot-assisted inguinal hernia repair
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Operable patients diagnosed as inguinal hernia
2) ECOG Performance Status (PS) is 0-2
3) Age is over 20 years old
4) Consent has been obtained for robot-assisted inguinal hernia repair with off-label medical care
5) The written consent has been obtained from the person
Key exclusion criteria
1) Cases with severe organ damage
2) Other cases judged by the investigator or investigator to be inappropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Takemasa |
Organization
SAPPORO MEDICAL UNIVERSITY
Division name
DEPARTMENT OF SURGERY, SURGICAL ONCOLOGY AND SCIENCE
Zip code
060-8556
Address
S1W16,Chuoh-ku Sapporo,Hokkaido Japan
TEL
011-611-2111
okuya@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Okuya |
Organization
SAPPORO MEDICAL UNIVERSITY
Division name
DEPARTMENT OF SURGERY, SURGICAL ONCOLOGY AND SCIENCE
Zip code
060-8556
Address
S1W16,Chuoh-ku Sapporo,Hokkaido Japan
TEL
011-611-2111
Homepage URL
okuya@sapmed.ac.jp
Sponsor or person
Institute
SAPPORO 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
Sapporo medical university hospital institutional review board
Address
S1W16,Chuoh-ku Sapporo,Hokkaido Japan
Tel
011-611-2111
ji-rskk@sapmed.ac.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 | 03 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2020 | Year | 03 | Month | 01 | Day |
Last modified on
| 2023 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045228
