UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000015570
Receipt No. R000018094
Scientific Title Cystine & Theanine (CT) study: for less invasiveness of laparoscopic colorectomy
Date of disclosure of the study information 2014/11/01
Last modified on 2014/10/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Cystine & Theanine (CT) study: for less invasiveness of laparoscopic colorectomy
Acronym CT study
Scientific Title Cystine & Theanine (CT) study: for less invasiveness of laparoscopic colorectomy
Scientific Title:Acronym CT study
Region
Japan

Condition
Condition colon cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Intervention for less invasiveness of laparoscopic colectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Serum CRP and albumine at POD 1/3/5/7
Key secondary outcomes Postoperative appetite

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Administration of cystine and theanine from pre-operative day 5 to post-operative day 5
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients who take laparoscopic colectomy
Key exclusion criteria Past surgical history of laparotomy except appendectomy
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideo Terahima
Organization Hitachi, Ltd. Hitachinaka General Hospital
Division name Department of surgery
Zip code
Address 20-1 Ishikawa-cho Hitachinaka-shi Ibaraki 312-0057 JAPAN
TEL 029-354-5111
Email h-tera@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Hiyama
Organization Hitachi, Ltd. Hitachinaka General Hospital
Division name Department of surgery
Zip code
Address 20-1 Ishikawa-cho Hitachinaka-shi Ibaraki 312-0057 JAPAN
TEL 029-354-5111
Homepage URL
Email kazuhiro.hiyama.hb@hitachi.com

Sponsor
Institute Hitachi, Ltd. Hitachinaka General Hospital
Institute
Department

Funding Source
Organization Hitachi, Ltd. Hitachinaka General Hospital
Organization
Division
Category of Funding Organization Self funding
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
2014 Year 11 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
2014 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 10 Month 30 Day
Last modified on
2014 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018094

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.