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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039654
Receipt No. 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 2020/04/03

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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
Email 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
Email okuya@sapmed.ac.jp

Sponsor
Institute SAPPORO MEDICAL UNIVERSITY
Institute
Department

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
Email 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
2022 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
2020 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045228

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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