Effect of MiniGo as add-on to Oral Laxatives for Children With Constipation and Fecal Incontinence
Functional Constipation, Fecal Incontinence in Children
About this trial
This is an interventional treatment trial for Functional Constipation focused on measuring trans anal irrigation, retentive fecal incontinence, low volume TAI
Eligibility Criteria
Inclusion Criteria:
- age 4-14 years
- medical history with fecal incontinence >1/week on a non-neurogenic but retentive basis (fulfills ROME-IV-criteria)
- non-responsive after min. 2 months treatment with polyethylene glycols and behavioral interventions (set times for toilet use)
Exclusion Criteria:
- Hirschsprungs disease
- anorectal malformations
- use of medications known to cause constipation (eg. anticholinergics)
- former use of low or high volume TAI or enemas
Contraindications for use of MiniGo-irrigation device:
- known stenosis of the rectum or intestinal tract
- colorectal cancer prior to surgical removal
- acute inflammatory bowel disease
- acute diverticulitis
- within 3 months of surgical procedures in the rectum or intestinal tract
- within 4 weeks of endoscopic polypectomy
- ischemic colitis
Sites / Locations
- Aalborg UniversitetshospitalRecruiting
- Aarhus UniversitetshospitalRecruiting
- Regionshospitalet GødstrupRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Polyethylene glycols
Polyethylene glycols and low volume trans anal irrigation
This group consists of children who have already been treated with oral laxatives (PEG) for at least 2 months, but still experience symptoms of constipation and fecal incontinence. Their PEG dosage will be adjusted to the ideal dose for the individual child (this will be evaluated by a health care professional), with the minimum dosage being the maintenance dose of 0,5mg/kg/day, and the maximum dosage being the disimpaction dose of 1,5mg/kg/day
This group consists of children who have already been treated with oral laxatives (PEG) for at least 2 months, but still experience symptoms of constipation and fecal incontinence. PEG dose will be adjusted in the same manner as in group a, but this group will also receive daily treatment with low volume trans anal irrigation.