UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024428 |
|---|---|
| Receipt number | 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 23:08:46 |
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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
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
shinichirokobayashi@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028115
