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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040640
Receipt No. 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

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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
Email 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
Email tetsuro.tominaga@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
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 Nagasaki University Hospital
Address 1-7-1 Sakamoto, Nagasaki, Japan
Tel 095-819-7304
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046384

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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