UMIN-CTR Clinical Trial

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