UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040640 |
|---|---|
| Receipt number | R000046384 |
| Scientific Title | Improved oncologic outcomes with increase of laparoscopic surgery in complete mesocolic excision with D3 lymph node dissection for T3/4a colon cancer: results of 1191 consecutive patients during a 10-year period: A retrospective cohort study |
| Date of disclosure of the study information | 2021/01/01 |
| Last modified on | 2020/06/03 17:01:13 |
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Basic information
Public title
Improved oncologic outcomes with increase of laparoscopic surgery in complete mesocolic excision with D3 lymph node dissection for T3/4a colon cancer: results of 1191 consecutive patients during a 10-year period: A retrospective cohort study
Acronym
laparoscopic CME with D3 improves prognosis
Scientific Title
Improved oncologic outcomes with increase of laparoscopic surgery in complete mesocolic excision with D3 lymph node dissection for T3/4a colon cancer: results of 1191 consecutive patients during a 10-year period: A retrospective cohort study
Scientific Title:Acronym
laparoscopic CME with D3 improves prognosis
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study investigated the oncological safety of laparoscopic CME with D3 dissection for pT3/4a colon cancer and whether the increase in laparoscopic surgery has changed clinical outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
5-year RFS
Key secondary outcomes
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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
clinical T3/T4a
Colon cancer
R0 resection
Key exclusion criteria
synchronous malignancies, emergency surgery, appendiceal tumor, familial tumor, inflammatory bowel disease,neuroendocrine tumor
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Tetsuro |
| Middle name | |
| Last name | Tominaga |
Organization
Nagasaki University Hospital
Division name
Surgical Oncology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-819-7304
tetsuro.tominaga@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuro |
| Middle name | |
| Last name | Tominaga |
Organization
Nagasaki University Hospital
Division name
Surgical Oncology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-819-7304
Homepage URL
tetsuro.tominaga@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
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
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki, Japan
Tel
095-819-7304
tetsuro.tominaga@nagasaki-u.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
| 2021 | Year | 01 | 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
| 2020 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No
Management information
Registered date
| 2020 | Year | 06 | Month | 03 | Day |
Last modified on
| 2020 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046384
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| Registered date | File name |
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