UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051059 |
|---|---|
| Receipt number | R000058221 |
| Scientific Title | A study on the relationship between intestinal microbiota before and after colectomy and patient factors in colorectal cancer patients |
| Date of disclosure of the study information | 2023/05/22 |
| Last modified on | 2024/03/29 09:42:46 |
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Basic information
Public title
A study on the relationship between intestinal microbiota before and after colectomy and patient factors in colorectal cancer patients
Acronym
A study on the relationship between intestinal microbiota before and after colectomy and patient factors in colorectal cancer patients
Scientific Title
A study on the relationship between intestinal microbiota before and after colectomy and patient factors in colorectal cancer patients
Scientific Title:Acronym
A study on the relationship between intestinal microbiota before and after colectomy and patient factors in colorectal cancer patients
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery | Operative medicine | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify patient factors related to dysbiosis due to colectomy in colorectal cancer patients
Basic objectives2
Others
Basic objectives -Others
Relationship between changes in intestinal microbiota (diversity of bacteria, types of bacteria) from preoperative to postoperative and patient factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between changes in intestinal microbiota (diversity of bacteria, types of bacteria) from preoperative to postoperative and patient factors
Key secondary outcomes
Relationship between the following patient factors, intestinal microbiota, and fecal content of organic acids
･ Preoperative patient factors [presence/absence of sarcopenia, skeletal muscle mass index (SMI), grip strength, drinking/smoking status]
･ Postoperative patient's factor( postoperative days)
･ Patient factors related to surgical operation (anesthesia method, presence/absence of epidural anesthesia, amount of transfusion, amount of bleeding, anesthesia time, type and amount of narcotics used, surgical site, surgical time)
･ Intestinal microbiota before surgery, 2 days after surgery, 5 days after surgery, and 14 days after surgery
･ Fecal content of organic acid before surgery and 5 days after surgery
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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Subjects aged 65 or over but under 85
(2) Patients scheduled for surgery
(3) Subjects with American Society of Anesthesiologists physical status (ASA-PS) I or II
(4) Subjects who plan to undergo laparoscopic-assisted colectomy due to colorectal cancer
(5) Subjects who understand the contents of this research and have obtained written consent
Key exclusion criteria
(1) Subjects who plan to have an artificial anus installed in the small intestine
(2) Subjects who underwent or are scheduled to undergo preoperative chemotherapy within one year prior to the scheduled date of surgery.
(3) Subjects who received antibacterial agents within 2 weeks prior to the scheduled date of surgery
(4) Subjects with chronic constipation, such as not having a bowel movement for more than a week.
(5) Subjects with concurrent cancer other than colorectal cancer
(6) Subjects with dementia or Parkinson's disease
(7) Subjects Participating in clinical research on pharmaceuticals, etc.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Taniguchi |
Organization
Saiseikai Yokohamashi Tobu Hospital
Division name
Department of Patient Support Center
Zip code
230-8765
Address
3-6-1 Shimosueyoshi Tsurumiku Yokohamashi Kanagawa
TEL
045-576-3000
taniguchihideki@outlook.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Taniguchi |
Organization
Saiseikai Yokohamashi Tobu Hospital
Division name
Department of Patient Support Center
Zip code
230-8765
Address
3-6-1 Shimosueyoshi Tsurumiku Yokohamashi Kanagawa
TEL
045-576-3000
Homepage URL
taniguchihideki@outlook.jp
Sponsor or person
Institute
Saiseikai Yokohamashi Tobu Hospital
Institute
Department
Personal name
Hideki Taniguchi
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Yokohamashi Tobu Hospital Institutional Review Board
Address
Shimosueyoshi Tsurumiku Yokohamashi Kanagawa
Tel
045-576-3000
k_harita@tobu.saiseikai.or.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
済生会横浜市東部病院（神奈川県）
Saiseikai Yokohamashi Tobu Hosptital, Kanagawa
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 05 | Month | 15 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058221
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