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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024428
Receipt No. R000028115
Scientific Title Intraluminal exfoliated malignant cells in laparoscopic colectomy for colon cancer
Date of disclosure of the study information 2016/11/30
Last modified on 2017/02/26

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Basic information
Public title Intraluminal exfoliated malignant cells in laparoscopic colectomy for colon cancer
Acronym Intraluminal exfoliated malignant cells in laparoscopic colectomy for colon cancer
Scientific Title Intraluminal exfoliated malignant cells in laparoscopic colectomy for colon cancer
Scientific Title:Acronym Intraluminal exfoliated malignant cells in laparoscopic colectomy for colon cancer
Region
Japan

Condition
Condition Colon Cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of our study was to assess the relationship between the incidence of exfoliated malignant cells and various factors and to compare the influence of laparoscopic with open colectomy on the incidence of exfoliated malignant cells in colon cancer surgery.
Basic objectives2 Others
Basic objectives -Others retrospective observational study
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes the incidence of exfoliated malignant cells
Key secondary outcomes The relationship between various clinical parameters

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

Not applicable
Gender Male and Female
Key inclusion criteria patients who underwent colectomy for colon cancer at department of Surgery in Nagasaki University Hospital
Key exclusion criteria the neoplasms have been already resected endoscopically
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Eguchi
Organization Nagasaki University Hospital
Division name Surgery
Zip code
Address sakamoto, 1-7-1
TEL 095-819-7316
Email sueguchi@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Kobayashi
Organization Nagasaki University Graduate School of Biomedical Sciences,
Division name Department of Surgery
Zip code
Address sakamoto 1-7-1
TEL 0958197316
Homepage URL
Email shinichirokobayashi@nagasaki-u.ac.jp

Sponsor
Institute Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
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
Email

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
2016 Year 11 Month 30 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 Completed
Date of protocol fixation
2006 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2007 Year 01 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information From 2007 to 2011, 93 patients who underwent colectomy for colon cancer at department of Surgery in Nagasaki University Hospital were enrolled prospectively in this study. 4 out of 93 patients were excluded because the neoplasms had been already resected endoscopically. Other data from 89 consecutive patients were collected and analyzed.

Management information
Registered date
2016 Year 10 Month 16 Day
Last modified on
2017 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028115

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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