UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of anorectal functions using high-definition anorectal manometry in patients with anal diseases or after colorectal surgery
Acronym	Evaluation of anorectal functions using high-definition anorectal manometry in patients with anal diseases or after colorectal surgery
Scientific Title	Evaluation of anorectal functions using high-definition anorectal manometry in patients with anal diseases or after colorectal surgery
Scientific Title:Acronym	Evaluation of anorectal functions using high-definition anorectal manometry in patients with anal diseases or after colorectal surgery
Region	Japan

Condition
Condition	patients with anal diseases, anorectal dysfunction or after colorectal surgery
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the change in defecation function after surgery, the process of recovery of defecation dysfunction, and the comparison of defecation function with anastomotic sites using high definition anorectal manometory (HD-ARM)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	anorectal pressures in rest, squeeze, and bear down
Key secondary outcomes	presence of rectoanal inhibitory reflex

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	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with anal diseases, anorectal dysfunction or after colorectal surgery
Key exclusion criteria	patients who had surgical complication such as anastomotic leakage or anastomotic stricture
Target sample size	160

Research contact person
Name of lead principal investigator	1st name Ken Middle name Last name Eto
Organization	The Jikei University School of Medicine
Division name	Department of Surgery
Zip code	105-8461
Address	3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Email	kyanaga@jikei.ac.jp

Public contact
Name of contact person	1st name Ken Middle name Last name Eto
Organization	The Jikei University School of Medicine
Division name	Department of Surgery
Zip code	105-8461
Address	3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Homepage URL
Email	etoken@jikei.ac.jp

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	The Jikei University School of Medicine
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 Ethical Committee of the Jikei University School of Medicine.
Address	3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo
Tel	03-3433-1111
Email	rinri@jikei.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	2017 Year 08 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
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	2017 Year 07 Month 18 Day
Date of IRB	2016 Year 07 Month 04 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2022 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Evaluation of anorectal functions using high-definition anorectal manometry

Management information
Registered date	2017 Year 07 Month 18 Day
Last modified on	2020 Year 07 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032354