UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028267
Receipt number R000032354
Scientific Title Evaluation of anorectal functions using high-definition anorectal manometry in patients with anal diseases or after colorectal surgery
Date of disclosure of the study information 2017/08/01
Last modified on 2020/07/21 07:58:35

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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 or person

Institute

The Jikei University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032354


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name