UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052095 |
|---|---|
| Receipt number | R000059457 |
| Scientific Title | Correlation between changes in intestinal microbiota and defecatory function before and after radical resection of right- and left-sided colon cancer. |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2024/09/29 01:58:04 |
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Basic information
Public title
Correlation between changes in intestinal microbiota and defecatory function before and after radical resection of right- and left-sided colon cancer.
Acronym
Correlation between changes in intestinal microbiota and defecatory function before and after radical resection of right- and left-sided colon cancer.
Scientific Title
Correlation between changes in intestinal microbiota and defecatory function before and after radical resection of right- and left-sided colon cancer.
Scientific Title:Acronym
Correlation between changes in intestinal microbiota and defecatory function before and after radical resection of right- and left-sided colon cancer.
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to statistically examine the changes in intestinal microbiota and defecation function before and after radical resection of right-sided with resection of the ileal valve and left-sided colon cancer, and to rescue patients suffering from reduced quality of life due to defecation function after surgery.
Basic objectives2
Others
Basic objectives -Others
By examining the specific intestinal microflora that affect defecation function, it is significant to help in the development of optimal probiotics.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pre- and postoperative voiding function
Key secondary outcomes
Pre- and postoperative intestinal flora
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with primary colorectal cancer
2) Patients who are 20 years of age or older at the time of consent
3) Patients whose gastrointestinal surgeon determines that surgical therapy is necessary
4) Patients whose written consent for this study has been obtained
5) Patients who will undergo ileal resection or right hemicolectomy of the colon for right-sided colorectal cancer or left hemicolectomy, descending colon resection, or sigmoid colon resection for left-sided colorectal cancer
Key exclusion criteria
1) Patients with multiple cancers
2) Patients with a history of autoimmune bowel disease
3) Patients with a history of severe hepatic dysfunction
4) Patients with a history of severe renal dysfunction
5) Patients receiving antimicrobial agents on a regular basis
6) Patients who received preparations that affect intestinal bacteria such as intestinal antiflatulents and probiotics preoperatively.
7) Patients who receive chemotherapy (antimetabolites, platinum, molecular-targeted drugs, immune checkpoint inhibitors) preoperatively and postoperatively.
8) Patients who receive chemotherapy (antimetabolite, platinum, molecular-targeted drug, immune checkpoint inhibitor) before and after surgery
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Sohei |
| Middle name | |
| Last name | Akuta |
Organization
Saitama Medical University International medical center
Division name
Gastrointestinal Surgery
Zip code
350-1298
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL
042-984-4111
sa46101@5931.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Sohei |
| Middle name | |
| Last name | Akuta |
Organization
Saitama Medical University International medical center
Division name
Gastrointestinal Surgery
Zip code
350-1298
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL
042-984-4111
Homepage URL
sohei.3402@gmail.com
Sponsor or person
Institute
Saitama Medical University International medical center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University International medical center
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
Saitama Medical University International medical center
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
Tel
042-984-4523
chikens@saitama-med.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
| 2023 | Year | 11 | 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
60
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
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1)Defecation function will be evaluated by interview four times before surgery, immediately after surgery, 6 months after surgery, and 12 months after surgery.
2)Defecation function will be evaluated using a questionnaire that combines the CSS, Wexner, and Brillstol stool shape scales, and the total score, individual defecation frequency, stool shape, and other parameters will be considered.
3)The intestinal microbiota will be identified from fecal samples taken three times before surgery, immediately after surgery, and 6 months later, and the distribution, occupancy, and quantity will be comprehensively evaluated. Pre- and postoperative will be statistically analyzed between the two groups as the comparison groups.
Chromosomal DNA of intestinal bacteria will be extracted from feces using Qiagen QiAamp DNA Microbiome Kit.
The 16S rRNA gene sequence of the chromosomal DNA is determined using a next-generation sequencer(Oxford Nanopore).
The intestinal microflora will be clarified by annotation.
Comprehensive evaluation of distribution, occupancy, and quantity, and comparative analysis will be performed.
4)Operative time, blood loss, number of lymph nodes dissected, postoperative complication rate, postoperative hospital stay, pathology, gender, age, BMI, American Society of Anesthesiologists - Physical Status, patient background factors such as history, comorbidities, history of laparotomy, defecation before and after surgery, and probiotic products. The results will also be reviewed with regard to the patient's preoperative and postoperative defecation status, and oral probiotic preparations.
Management information
Registered date
| 2023 | Year | 09 | Month | 03 | Day |
Last modified on
| 2024 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059457
