UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032317 |
|---|---|
| Receipt number | R000036858 |
| Scientific Title | Profiling of preoperative intestinal microenvironment and muscle mass, and its association with postoperative outcomes in patients undergoing gastrointestinal surgery. A multiple institutional prospective study |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2021/04/21 09:56:45 |
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Basic information
Public title
Profiling of preoperative intestinal microenvironment and muscle mass, and its association with postoperative outcomes in patients undergoing gastrointestinal surgery. A multiple institutional prospective study
Acronym
Profiling of preoperative intestinal microenvironment and muscle mass in patients undergoing gastrointestinal surgery
Scientific Title
Profiling of preoperative intestinal microenvironment and muscle mass, and its association with postoperative outcomes in patients undergoing gastrointestinal surgery. A multiple institutional prospective study
Scientific Title:Acronym
Profiling of preoperative intestinal microenvironment and muscle mass in patients undergoing gastrointestinal surgery
Region
| Japan |
Condition
Condition
Patients who are going to undergo gastrointestinal surgery in Nagoya University Hospital and its associated hospitals.
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between the preoperative intestinal microenvironment/muscle mass and postoperative complications/long term outcome in patients undergoing a gastrointestinal surgery.
Basic objectives2
Others
Basic objectives -Others
To clarify the impact of intestinal microenvironment and muscle mass on the postoperative and long term outcomes in patients undergoing gastrointestinal surgery.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the association between the preoperative intestinal microenvironment/muscle mass and postoperative complications/postoperative hospital stay in patients undergoing a gastrointestinal surgery.
Key secondary outcomes
To investigate the association between the preoperative intestinal microenvironment/muscle mass and preoperative patient characteristics.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
all patients undergoing gastrointestinal surgery
Key exclusion criteria
not applicable
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Yokoyama |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2222
yyoko@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Yokoyama |
Organization
Nagoya University Hospital
Division name
Department of Surgery 1
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
0527442222
Homepage URL
yyoko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine
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
Nagoya University Ethics Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
0527442479
ethics@med.nagoya-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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not applicable
Management information
Registered date
| 2018 | Year | 04 | Month | 19 | Day |
Last modified on
| 2021 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036858
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
