UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038787 |
|---|---|
| Receipt number | R000044218 |
| Scientific Title | The influence of rectal surgery for pelvic function. |
| Date of disclosure of the study information | 2019/12/04 |
| Last modified on | 2019/12/04 13:35:23 |
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Basic information
Public title
The influence of rectal surgery for pelvic function.
Acronym
The influence of rectal surgery for pelvic function.
Scientific Title
The influence of rectal surgery for pelvic function.
Scientific Title:Acronym
The influence of rectal surgery for pelvic function.
Region
| Japan |
Condition
Condition
rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, the difference in the effect on the pelvic function due to the difference in the surgical procedure (open surgery, laparoscopic surgery, robot-assisted surgery) and radiation (total pelvic irradiation, IMRT) technique, anal function test (rectal Internal pressure measurement), and surveys on defecation, urination, and sexual functions, and measurement of anal canal and tumor hardness by transanal ultrasonography (in the latter case, depth of penetration diagnosis) over time Go on. By clarifying the relationship between these results and pelvic function, the selection of the surgical procedure and the usefulness of the current treatment method are evaluated, and the usefulness of the current treatment method is evaluated. I would like to contribute to the development of functional preservation therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
anorectal function:
manometry, Wexner score, FIQL at before surgery, 1, 3, 6, 9, 12, 24, and 36 months after surgery.
Key secondary outcomes
urinary function:
IPSS, QOL score at before surgery, 1, 3, 6, 9, 12, 24, and 36 months after surgery.
sexsual function:
IIEF at before surgery, 1, 3, 6, 9, 12, 24, and 36 months after surgery for men.
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
patient with rectal surgery
Key exclusion criteria
none
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Soichiro |
| Middle name | |
| Last name | Ishihara |
Organization
the university of tokyo
Division name
surgical oncology
Zip code
113-8655
Address
7-3-1 hongo, bunkyo-ku
TEL
03-3815-5411
soichiro.ishihara@gmail.com
Public contact
Name of contact person
| 1st name | yugo |
| Middle name | |
| Last name | Hirata |
Organization
the university of tokyo
Division name
surgical oncology
Zip code
113-8655
Address
7-3-1 hongo, bunkyo-ku
TEL
03-3815-5411
Homepage URL
yugoism777@yahoo.co.jp
Sponsor or person
Institute
the university of tokyo
Institute
Department
Personal name
Funding Source
Organization
none
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
the university of tokyo
Address
7-3-1 hongo, bunkyo-ku
Tel
03-3815-5411
yugoism777@yahoo.co.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
東京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 04 | 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
| 2013 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Targeting patients undergoing rectal surgery in our department. Preoperative, 1-month, 3-month, 6-month, 9-month, 12-month, 24-month, and 36-month anal function tests (intrarectal pressure measurement) and surveys using questionnaires regarding defecation, urination, and sexual functions In addition, elastography with transanal ultrasound is evaluated. In the anal function test, a microchip transducer catheter is inserted into the rectum about 5 cm from the anal margin, and the functional anal canal length, maximum static pressure, and voluntary contraction pressure are measured by the withdrawal method. Anal function tests have been performed in the usual practice, and the test time is about 15 minutes at a time. The questionnaire survey is conducted for research purposes, and it takes about 10 minutes to complete.
Management information
Registered date
| 2019 | Year | 12 | Month | 04 | Day |
Last modified on
| 2019 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044218
