UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024950 |
|---|---|
| Receipt number | 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 10:10:25 |
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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
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
kmaeda@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Surgery, Fujita Health University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028600
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
