Healthy Bowels Study - A randomised controlled trial of transcutaneous electrical stimulation to treat constipation caused by anorectal retention in children.

Not Applicable

Completed

Conditions: Chronic Constipation
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Registration Number: ACTRN12612001009808

Lead Sponsor: Murdoch Childrens Research Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 120

Inclusion Criteria

Children (4-18yrs) with treatment-resistant Anorectal Retention constipation confirmed by Nuclear Transit Study. Patients with faecaloma will be included.

For entry patients will be assessed for anorectal retention by
a/ History and presence of palpable faecaloma
b/ Confirmation by radio-nuclear transit study (scintigraphy)

Exclusion Criteria

1. Has a heart pacemaker, neurological defects (including slow transit constipation, epilepsy), cochlear implant or ventricular-peritoneal shunt inserted.
2. Hormonal/metabolic disorder, bowel surgery, cancer or pregnancy.
3. Previous TES therapy.
4. Unable to access the internet each day to login to the computer program for medication dose and to send copies of paper diary Charts.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
axative: Medication dosage administered to patient to maintain bowel consistency of type 4 Bristol Stool Chart.<br>(as per IMPACT Paediatric Bowel Care Pathway - Australia) 2006[End of week 8 of CBT+TES/ CBT];Percent of patients using laxatives at end of 8 weeks of CBT+TES/ CBT[End of week 8 of CBT+TES/ CBT]

Secondary Outcome Measures

Name	Time	Method
Time to ceasing laxative use[Daily collection of laxative use data for the full term of the study.];Number of patients ceasing laxative use[Daily collection of laxative use data for the full term of the study.];Defecation episodes/day[Daily collection of patient diary data for the full term of the study.];soiling episodes/day[Daily collection of patient diary data for the full term of the study.];Quality of life - PAC qol, PAC sym questionnaire[Before starting trial, post disimpaction (pre CBT commencing), Post 8 weeks CBT+TES/ CBT];Consistency of stool- as per Bristol Stool Chart.[Daily collection of patient diary data for the full term of the study.]