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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024950
Receipt No. R000028600
Scientific Title A prospective multicenter clinical research of transanal irrigation in patients with faecal incontinence or chronic constipation resistant to conservative bowel management
Date of disclosure of the study information 2016/11/24
Last modified on 2018/06/03

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Basic information
Public title A prospective multicenter clinical research of transanal irrigation in patients with faecal incontinence or chronic constipation resistant to conservative bowel management
Acronym A prospective multicenter clinical research of transanal irrigation in patients with faecal incontinence or chronic constipation resistant to conservative bowel management
Scientific Title A prospective multicenter clinical research of transanal irrigation in patients with faecal incontinence or chronic constipation resistant to conservative bowel management
Scientific Title:Acronym A prospective multicenter clinical research of transanal irrigation in patients with faecal incontinence or chronic constipation resistant to conservative bowel management
Region
Japan

Condition
Condition chronic faecal incontinence and constipation
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For Japanese patients suffering from faecal incontinence or chronic constipation resistant to conservative bowel care, Peristeen transanal irrigation system has been registered in Japan to support the use of transanal irrigation as an additional treatment modality. This clinical research is intended to evaluate the safety and efficacy of transanal irrigation using Peristeen in a Japanese setting.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Using a VAS (Visual Analogue Scale), patients are asked to evaluate their satisfaction with current bowel management
Key secondary outcomes Number and ratio of patients who wish to continue using transanal irrigation after end of clinical research
Quality of Life improvement as measured by EQ-5D instrument
Need for and frequency of use of bowel medications
Need for digital evacuation
Daily time required for bowel management
Need for use if diapers/pads, number of diapers/pads used weekly
Number of new urinary tract infections(UTI)
Transanal irrigation-specific items
NBD Score
CCFIS Score
CSS Score
LARS Score

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 Faecal incontinence and/or constipation resistant to conservative bowel management (medicinal treatment, suppositories, enemas, bio feedback etc.)
Transanal irrigation naive
Post-surgical patients: a valid endoscopy or barium enema must be available to exclude rectal conditions contraindicating irrigation
Be at least 20 years of age and have full legal capacity
Be willing and able to comply with investigation procedures
Have given written informed consent
Key exclusion criteria Known anal or colorectal stenosis
Known colorectal cancer
Acute inflammatory bowel disease
Acute diverticulitis
Within 3 months of anal or colorectal surgery
Within 4 weeks of endoscopic polypectomy
Ischaemic colitis
Current or planned pregnancy or nursing women, in the investigational period
Currently performs transanal irrigation using a device other than Peristeen Anal Irrigation System
Depending on the condition each patient, the patient who the physician judged that it is not aplicable in this clinical research
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koutaro Maeda
Organization Fujita Health University, School of Medicine
Division name Department of Surgery
Zip code
Address Dengakugakubo 1-98, Kutsukake-cho, Toyoake, Aichi, Japan
TEL 0562-93-2111
Email kmaeda@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koutaro Maeda
Organization Fujita Health University, School of Medicine
Division name Department of Surgery
Zip code
Address Dengakugakubo 1-98, Kutsukake-cho, Toyoake, Aichi, Japan
TEL 0562-93-2111
Homepage URL
Email kmaeda@fujita-hu.ac.jp

Sponsor
Institute Department of Surgery, Fujita Health University, School of Medicine
Institute
Department

Funding Source
Organization Coloplast. K. K
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Denmark

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/jcoloproctology/71/2/71_70/_pdf
Number of participants that the trial has enrolled
Results
TAI was performed in 32 patients. Out of the 25 patients who completed the 10 weeks TAI therapy, 23 patients wished to continue TAI after the study. The VAS of the satisfaction in the 23 success patients significantly improved from a median of 2.2 before TAI to 7.5 at the 10th week after its commencement. Colonic perforation occurred in 3 patients.
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 Completed
Date of protocol fixation
2016 Year 11 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 20 Day
Last follow-up date
2017 Year 05 Month 25 Day
Date of closure to data entry
2017 Year 05 Month 25 Day
Date trial data considered complete
2017 Year 05 Month 25 Day
Date analysis concluded
2017 Year 07 Month 31 Day

Other
Other related information "This clinical trial will include patients who fulfill the selection criteria and submit written informed consent.
Through patients evaluating Peristeen satisfaction of use and improvement of applicable scores related to bowel movements, this clinical research aims to confirm that Peristeen is also useful for Japanese patients with bowel dysfuntion. "

Management information
Registered date
2016 Year 11 Month 22 Day
Last modified on
2018 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028600

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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