UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intraluminal exfoliated malignant cells in laparoscopic colectomy for colon cancer
Title of the study (Brief title)	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	Susumu Eguchi
Organization	Nagasaki University Hospital
Division name	Surgery
Address	sakamoto, 1-7-1
TEL	095-819-7316
Email	sueguchi@nagasaki-u.ac.jp

Public contact
Name of contact person	Shinichiro Kobayashi
Organization	Nagasaki University Graduate School of Biomedical Sciences,
Division name	Department of Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 12 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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