UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038179 |
|---|---|
| Receipt number | 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 | 2021/11/25 09:52:18 |
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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
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
takakura@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
303
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
No longer 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
| 2021 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043335
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| Registered date | File name |
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