UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015365 |
|---|---|
| Receipt number | R000017880 |
| Scientific Title | Clinical study of robot assisted laparoscopic colorectal surgery |
| Date of disclosure of the study information | 2014/10/07 |
| Last modified on | 2022/10/17 11:48:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical study of robot assisted laparoscopic colorectal surgery
Acronym
Clinical study of robot assisted laparoscopic colorectal surgery
Scientific Title
Clinical study of robot assisted laparoscopic colorectal surgery
Scientific Title:Acronym
Clinical study of robot assisted laparoscopic colorectal surgery
Region
| Japan |
Condition
Condition
colorectal malignant diseases
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of robot assisted colorectal surgery
Basic objectives2
Others
Basic objectives -Others
Oncological outcome
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
rate of adverse event
Key secondary outcomes
overall survival
disease free survival
completion rate of robot assisted surgery
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Robot assisted surgery
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Resectable colorectal malignant diseases
Key exclusion criteria
transverse colon malignant diseases
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Tomoharu |
| Middle name | |
| Last name | Shimizu |
Organization
Shiga University of Medical Science
Division name
Division of Gastrointestinal Surgery, Department of Surgery
Zip code
520-2192
Address
Seta, Tsukinowa-cho, Otsu, Shiga, 520-2192 JAPAN
TEL
077-548-2238
tomoharu@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoharu |
| Middle name | |
| Last name | Shimizu |
Organization
Shiga University of Medical Science
Division name
Division of Gastrointestinal Surgery, Department of Surgery
Zip code
520-2192
Address
Seta, Tsukinowa-cho, Otsu, Shiga, 520-2192 JAPAN
TEL
077-548-2111
Homepage URL
tomoharu@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
Shiga University of Medical Science, Research Ethics Office
Address
Seta, Tsukinowa-cho, Otsu, Shiga, 520-2192 JAPAN
Tel
077-548-2111
hqrec@belle.shiga-med.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
滋賀医科大学附属病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
5
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 | 07 | Month | 23 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 31 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 06 | 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
| 2014 | Year | 10 | Month | 07 | Day |
Last modified on
| 2022 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017880
