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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032317
Receipt No. 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 2018/05/20

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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
Middle name
Last name Yukihiro Yokoyama
Organization Nagoya University Graduate School of Medicine
Division name Division of Surgical Oncology, Department of Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL 052-744-2222
Email yyoko@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihiro Yokoyama
Organization Nagoya University Hospital
Division name Department of Surgery 1
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL 052-744-2222
Homepage URL
Email yyoko@med.nagoya-u.ac.jp

Sponsor
Institute Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine
Institute
Department

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
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
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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 10 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
2018 Year 04 Month 19 Day
Last modified on
2018 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036858

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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