UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033355 |
|---|---|
| Receipt number | R000038023 |
| Scientific Title | Prospective study of laparoscopic lateral lymph node dissection for rectal cancer |
| Date of disclosure of the study information | 2018/07/10 |
| Last modified on | 2018/07/10 16:41:47 |
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Basic information
Public title
Prospective study of laparoscopic lateral lymph node dissection for rectal cancer
Acronym
Prospective study of laparoscopic lateral lymph node dissection for rectal cancer
Scientific Title
Prospective study of laparoscopic lateral lymph node dissection for rectal cancer
Scientific Title:Acronym
Prospective study of laparoscopic lateral lymph node dissection for rectal cancer
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of laparoscopic lateral lymph node dissection.
Basic objectives2
Others
Basic objectives -Others
Observational Study
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety; rate of Grade 3 or 4 adverse events
Key secondary outcomes
Blood loss, Operation time, sexual function, urinary function, relapse free survival rate, and overall survival rate
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. Rectal cancer is proved histologically by biopsy of rectal primary tumor.
2. Preoperative findings indicate clinical stage II or III.
Key exclusion criteria
1. Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma
2. Cases with uncontrollable diabetes
3. Cases with uncontrollable congestive heart failure, angina pectoris, hypertension, arrhythmia
4. It is judged that psychosis or psychiatric symptoms are merged and it is difficult to participate in the study.
5. In addition, it is a case that the doctor in charge judged that registration of this study is inappropriate.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Nishimura |
Organization
Osaka International Cancer Institute
Division name
Department of Gastroenterological surgery
Zip code
Address
541-8567 Ohteme 3-1-69, Osaka, Osaka, Japan
TEL
0669451181
jnishimura@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Nishimura |
Organization
Osaka International Cancer Institute
Division name
Department of Gastroenterological surgery
Zip code
Address
541-8567 Ohteme 3-1-69, Osaka, Osaka, Japan
TEL
0669451181
Homepage URL
jnishimura@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Multi-Center Clinical Study Group of Osaka; Colorectal Cancer Treatment Group (MCSGO)
Institute
Department
Personal name
Funding Source
Organization
SCCRE
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
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
| 2018 | Year | 07 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 05 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not yet
Management information
Registered date
| 2018 | Year | 07 | Month | 10 | Day |
Last modified on
| 2018 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038023
