UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011535 |
|---|---|
| Receipt number | R000013492 |
| Scientific Title | Study of robot assisted laparoscopic lateral lymph node dissection for advanced lower rectal cancer |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2017/02/21 12:25:48 |
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Basic information
Public title
Study of robot assisted laparoscopic lateral lymph node dissection for advanced lower rectal cancer
Acronym
Study of robot assisted laparoscopic lateral lymph node dissection for advanced lower rectal cancer
Scientific Title
Study of robot assisted laparoscopic lateral lymph node dissection for advanced lower rectal cancer
Scientific Title:Acronym
Study of robot assisted laparoscopic lateral lymph node dissection for advanced lower rectal cancer
Region
| Japan |
Condition
Condition
advanced rectal cancer
Classification by specialty
| Gastrointestinal surgery | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
assessment of safety and efficacy of robot-assisted lateral lymph node dissection for rectal surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
number of dessected lymph nodes
Key secondary outcomes
frequency of adverse events
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
| Device,equipment |
Interventions/Control_1
The use of robot-assisted surgical system for laparoscopic rectal 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
| Not applicable |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients with rectal cancer who are applicable for laparoscopic rectal surgery.
(2) Written informed consent is essential.
Key exclusion criteria
(1)Woman in pregnancy or woman of child bearing potential and breast-feeding woman.
(2)Patients with psychiatric disease.
(3)Cases which the investigators think inadequate to this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Kakeji |
Organization
Kobe University
Division name
Department of Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuou-ku, Kobe, Japan
TEL
078-382-5925
kakeji@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Sumi |
Organization
Kobe University
Division name
Department of Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuou-ku, Kobe, Japan
TEL
078-382-5925
Homepage URL
sumiy@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2013 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 20 | Day |
Last modified on
| 2017 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013492
