A prospective multicenter clinical research of transanal irrigation in patients with faecal incontinence or chronic constipation resistant to conservative bowel management
- Conditions
- chronic faecal incontinence and constipation
- Registration Number
- JPRN-UMIN000024950
- Lead Sponsor
- Department of Surgery, Fujita Health University, School of Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method sing a VAS (Visual Analogue Scale), patients are asked to evaluate their satisfaction with current bowel management
- Secondary Outcome Measures
Name Time Method umber 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