UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038179
Receipt No. R000043335
Scientific Title Multicenter observational study on noninvasive gastrointestinal tissue oxygen saturation measurement using near infrared spectroscopy in left colorectal surgery.
Date of disclosure of the study information 2019/10/02
Last modified on 2019/11/27

* 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 Multicenter observational study on noninvasive gastrointestinal tissue oxygen saturation measurement using near infrared spectroscopy in left colorectal surgery.
Acronym Observational study on noninvasive gastrointestinal tissue oxygen saturation measurement in left colorectal surgery.
Scientific Title Multicenter observational study on noninvasive gastrointestinal tissue oxygen saturation measurement using near infrared spectroscopy in left colorectal surgery.
Scientific Title:Acronym Observational study on noninvasive gastrointestinal tissue oxygen saturation measurement in left colorectal surgery.
Region
Japan

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

Objectives
Narrative objectives1 To measure changes in gastrointestinal tissue oxygen saturation due to surgical procedures and vascular dissection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in gastrointestinal tissue oxygen saturation with or without preservation of left colic artery.
Key secondary outcomes

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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Patient who is planed to receive colorectal dissection and anastomosis with DST.
2) Any T, N, M, Stage is allowed.
3) Eastern Cooperative Oncology Group (ECOG) Performance Status is 0 or 1.
4) American Society of Anesthetists (ASA) - Physical Status is class 1 or 2.
5) Patient's age is 20 years or more and less than 80 years.
6) Written informed consent is obtained for participation in this study.
Key exclusion criteria 1) Patient who is planed to receive two or more anastomoses due to multiple colorectal cancer
2) Patient scheduled to undergo simultaneous resection of other organs due to double cancer
3) Patient with intraperitoneal infection (peritonitis or intraabdominal abscess)
4) Patient who is judged not suitable for this study by the doctor.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Hideki
Middle name
Last name Ohdan
Organization Hiroshima University
Division name Department of Ganstroenterological and Transplant Surgery
Zip code 734-8551
Address 1-2-3 Kasumi Minamiku Hiroshima
TEL 082-257-5222
Email hohdan@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Yuji
Middle name
Last name Takakura
Organization Hiroshima University
Division name Department of Ganstroenterological and Transplant Surgery
Zip code 734-8551
Address 1-2-3 Kasumi Minamiku Hiroshima
TEL 082-257-5222
Homepage URL
Email takakura@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization Hiroshima Surgical study group of Clinical Oncology (HiSCO)
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 Hiroshima University Epidemiological Research Ethics Review Committee
Address 1-2-3 Kasumi Minamiku Hiroshima
Tel 082-257-5907
Email iryo-seisaku@office.hiroshima-u.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 広島大学病院(広島県)、安佐市民病院(広島県)、尾道総合病院(広島県)、県立広島病院(広島県)、中国労災病院(広島県)、東広島医療センター(広島県)、広島市民病院(広島県)

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 02 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 Open public recruiting
Date of protocol fixation
2019 Year 09 Month 05 Day
Date of IRB
2019 Year 09 Month 05 Day
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2023 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Measure changes in gastrointestinal tissue oxygen saturation before and after mesenteric dissection.
Observe the relationship between surgical procedure and postoperative complications and gastrointestinal tissue oxygen saturation.

Management information
Registered date
2019 Year 10 Month 02 Day
Last modified on
2019 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043335

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.