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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032697
Receipt No. R000037165
Scientific Title Evaluation of safety and efficacy of perioperative administration of TJ-100 in patients with postoperative functional aberration of the gastrointestinal tract due to surgery for colon cancer
Date of disclosure of the study information 2018/05/24
Last modified on 2019/05/26

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Basic information
Public title Evaluation of safety and efficacy of perioperative administration of TJ-100 in patients with postoperative functional aberration of the gastrointestinal tract due to surgery for colon cancer
Acronym Evaluation of safety and efficacy of perioperative administration of TJ-100 in patients with postoperative functional aberration of the gastrointestinal tract due to surgery for colon cancer
Scientific Title Evaluation of safety and efficacy of perioperative administration of TJ-100 in patients with postoperative functional aberration of the gastrointestinal tract due to surgery for colon cancer
Scientific Title:Acronym Evaluation of safety and efficacy of perioperative administration of TJ-100 in patients with postoperative functional aberration of the gastrointestinal tract due to surgery for colon cancer
Region
Japan

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

Objectives
Narrative objectives1 To determine whether perioperative administration of TJ-100 affects postoperative recovery of gastrointestinal function in patients undergoing surgery for colon cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the time until first flatus following colon surgery
Key secondary outcomes 1.The time until first defecation following colon surgery
2.CRP, WBC, neutrophil of POD 1,3
3.The maximumu of body temperature
4.Hospital stay after colorectal surgery
5.Postoperative complication
6.Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 oral administration of TJ-100(15g/day) in perioperative surgery

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 1.Patients with curative resection for colon cancer including cancer of the rectosigmoid that had been diagnosed pre-operatively
2.Patients with a performance status of 0 or 1
3.Patients able to tolerate oral administration of TJ-100
4.Patients aged 20 years or older
5.Patients able to provide written informed consent
Key exclusion criteria 1.Patients taking other Kampo medicines
2.Patients were pregnant, possibly pregnant or considering pregnancy
3.Patients with serious ischemic heart disease
4.Patients with cirrhosis or active hepatitis
5.Patients with dyspnea requiring oxygen administration
6.Patients under dialysis due to chronic renal failure
7.Patients requiring combined resection of any other organ
8.Patients ineligible for the study for any other reason, as judged by the investigator
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Takemasa
Organization Sapporo Medical University
Division name Department of Surgery, Surgical Oncology and Science
Zip code 060-8543
Address Sapporo, Hokkaido 060-8543, Japan
TEL 011-611-2111
Email itakemasa@sapmed.ac.jp

Public contact
Name of contact person
1st name Toshihiko
Middle name
Last name Nishidate
Organization Sapporo Medical University
Division name Department of Surgery, Surgical Oncology and Science
Zip code 060-8543
Address Sapporo, Hokkaido 060-8543, Japan
TEL 011-611-2111
Homepage URL
Email nisidate@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University
Institute
Department

Funding Source
Organization Sapporo Medical University
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 Sapporo Medical University
Address Sapporo, Hokkaido 060-8543, Japan
Tel 011-611-2111
Email rskk@sapmed.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
2018 Year 05 Month 24 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
2017 Year 12 Month 14 Day
Date of IRB
2017 Year 12 Month 15 Day
Anticipated trial start date
2018 Year 01 Month 18 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 24 Day
Last modified on
2019 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037165

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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