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

Children (aged 4-8 years) with chronic constipation caused by anorectal retention treated with current best treatment (CBT) plus transcutaneous electrical stimulation compared to CBT alone comparing laxative usage after 8 weeks of TES.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001009808

Acronym

Healthy Bowels Study

Enrollment

119

Registered

2012-09-19

Start date

2014-08-01

Completion date

2015-05-29

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will assess if a safe non-invasive transcutantous electrical stimulation can treat chronic constipation from the anorectal retention sub-group (the most common type of chronic constipation). Hypothesis TESIC can increase large bowel motility and defecation to overcome chronic constipation in children with AR, and is more effective than current best treatment (CBT, laxatives, diet, toilet timing and posture, education about brain-gut axis) alone.

Interventions

Randomised Current Best Treatment (CBT) vs. CBT plus transcutaneous electrical stimulation (TES). Open treatment, Blinded analysis. CBT involves 4 x 3hours patient education sessions (12 hours in total) which include basic digestive function, prescriptive diet and maintenance medication. These are given over 4 weeks before the 8 weeks of TES commences. TES involves patients having daily stimulation using the TES device (4 electrode pads over the abdomen and lower back) for one hour daily for 8 weeks. For entry patients will be assessed for anorectal retention by A/ History and presence of palpable faecaloma B/ confirmation by radio-nuclear transit study All subjects receive: a disimpaction regime using over the counter stool softener and laxative (similar to bowel washout used before colonoscopy), education on how the bowel works, controlled diet and fluid intake, Maintenance medication: Stool softener and laxative for 14 weeks. Amount of laxative will be increased or decreased to maintain stool at 1 cup per day and medium consistency (measured using Bristol Stool Chart) and Patients will fill in an online diary each day. At 4 weeks, patients will be randomised to Group A or B. Group A (control group) continue current best treatment. Which involves a combination of detailed education and laxative medication for the duration of 8 weeks. Group B (electrical stimulation group) continue with current best treatment (as mentioned above) plus the use of the Transcutaneous Electrical Stimulation (TES) used daily for 1 hour each day, for the duration of 8 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

4 Years to 18 Years

Healthy volunteers

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.

Outcome results