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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038787
Receipt No. 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

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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
Email 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
Email yugoism777@yahoo.co.jp

Sponsor
Institute the university of tokyo
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044218

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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